IEC 60601-1-2:2014
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Amended by
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Superseded date
11-09-2020
Superseded by
Language(s)
English - French
Published date
25-02-2014
Publisher
Important note : Users cannot be edited or removed once added to your Multi user PDF.
IEC 60601-1-2:2014 applies to the basic safety and essential performance of Medical Equipment (ME) equipment and ME systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by me equipment and me systems. This collateral standard to IEC 60601-1 specifies general requirements and tests for basic safety and essential performance with regard to electromagnetic disturbances and for electromagnetic emissions of ME equipment and ME systems. They are in addition to the requirements of the general standard IEC 60601-1 and serve as the basis for particular standards. This fourth edition cancels and replaces the third edition of IEC 60601-1-2, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications:
- specification of immunity test levels according to the environments of intended use, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments;
- specification of tests and test levels to improve the safety of medical electrical equipment and medical electrical systems when portable RF communications equipment is used closer to the medical electrical equipment than was recommended based on the immunity test levels that were specified in the third edition;
- specification of immunity tests and immunity test levels according to the ports of the medical electrical equipment or medical electrical system;
- specification of immunity test levels based on the reasonably foreseeable maximum level of electromagnetic disturbances in the environments of intended use, resulting in some immunity test levels that are higher than in the previous edition; and
- better harmonization with the risk concepts of basic safety and essential performance, including deletion of the defined term "life-supporting". This new edition includes the following main additions:
- guidance for determination of immunity test levels for special environments;
- guidance for adjustment of immunity test levels when special considerations of mitigations or intended use are applicable;
- guidance on risk management for basic safety and essential performance with regard to electromagnetic disturbances; and
- guidance on identification of immunity pass/fail criteria.
| Committee |
TC 62/SC 62A
|
| DevelopmentNote |
NEW CHILD AMD 1 2020 IS NOW ADDED
|
| DocumentType |
Standard
|
| Pages |
285
|
| ProductNote |
NEW CHILD AMD 1 2020 IS NOW ADDED
|
| PublisherName |
International Electrotechnical Committee
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| JIS T 0601-1-2:2023 | Identical |
| AS IEC 60601.1.2:2017 | Identical |
| IS 13450 : Part 1 : SEC 2 : 2018 | Identical |
| NEN EN IEC 60601-1-2 : 2015 | Identical |
| DIN EN 60601-1-2:2016-05 | Identical |
| JIS T 0601-1-2:2018 | Identical |
| SN EN 60601-1-2 : 2015 | Identical |
| BS 5724-1.2(1993) : 1993 AMD 10002 | Identical |
| VDE 0750-1-2 : 2016 | Identical |
| NEN 10601-1-2 : 1993 | Identical |
| DIN EN 60601-1-2 : 2006-10 | Identical |
| CEI EN 60601-1-2 : 2016 | Identical |
| ONORM OVE EN 60601-1-2 : 2016 | Identical |
| NF EN 60601-1-2 : 2016 | Identical |
| NBN EN 60601 1-2 : 2015 | Identical |
| EN 60601-1-2:2015 | Identical |
| CSA C22.2 No. 60601.1.2A : 2006 | Identical |
| GOST R IEC 60601-1-2 : 2014 | Identical |
| ANSI/AAMI/IEC 60601-1-2:2014 | Identical |
| PNE-FprEN 60601-1-2 | Identical |
| UNE-EN 60601-1-2:2008 | Identical |
| CSA C22.2 No. 601.1.2 : 1994 | Identical |
| PN EN 60601-1-2 : 2015 | Identical |
| UNE-EN 60601-1-2:2015 | Identical |
| BS EN 60601-1-2:2015 | Identical |
| DIN EN 60601-2-30 : 2000 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT |
| I.S. EN 80601-2-35:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| CSA C22.2 No. 80601-2-56 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT |
| BS EN 60601-2-31 : 2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| CEI EN 60601-1-11 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| CEI EN 62464-1 : 2007 | MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - PART 1: DETERMINATION OF ESSENTIAL IMAGE QUALITY PARAMETERS |
| BS EN 60601-1-11:2015 | Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| CSA C22.2 No. 601.2.33 : 0 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS |
| BS EN ISO 80601-2-13:2012 | Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| CSA C22.2 No. 60601.2.27 : 2011 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT |
| ASTM F 3020 : 2016 | Performance Standard for Hand-Worn Metal Detectors Used in Safety and Security |
| CSA C22.2 No. 60601-2-20 : 2010 : INC : COR 1 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS |
| BS EN 60601-2-36:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy |
| ASTM E 1965 : 1998 : R2009 | Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature |
| PD IEC/TR 60601-4-2:2016 | Medical electrical equipment Guidance and interpretation. Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
| 03/111582 DC : DRAFT JULY 2003 | BS EN ISO 18779 - DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS |
| IEEE 1073.4.1 : 2000 | STANDARD FOR MEDICAL DEVICE COMMUNICATIONS - PHYSICAL LAYER INTERFACE - CABLE CONNECTED |
| I.S. EN 60601-2-31:2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| 11/30199851 DC : 0 | BS EN 60601-2-63 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT |
| NF EN 80601-2-58:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
| BS EN 60601-2-20 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS |
| UNI EN ISO 80601-2-61 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
| BS EN ISO 80601-2-61:2011 | Medical electrical equipment Particular requirements for basic safety and essential performance of pulse oximeter equipment |
| I.S. EN ISO 22523:2006 | EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
| 17/30357887 DC : 0 | BS ISO 20493 - TRADITIONAL CHINESE MEDICINE - INFRARED MOXIBUSTION-LIKE INSTRUMENT |
| CEI EN 60601-2-49 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT |
| I.S. EN ISO 8835-4:2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
| NF EN 60601-1-8 : 2007 AMD 11 2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
| CSA C22.2 No. 60601.2.49:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT |
| BS ISO 11197 : 2016 | MEDICAL SUPPLY UNITS |
| ANSI/AAMI CI86:2017 | COCHLEAR IMPLANT SYSTEMS: REQUIREMENTS FOR SAFETY, FUNCTIONAL VERIFICATION, LABELING AND RELIABILITY REPORTING |
| NF EN 60731 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY |
| AAMI ISO 80601-2-35 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| BS EN ISO 80601-2-56:2017 | Medical electrical equipment Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement |
| PREN ISO 80601-2-61 : DRAFT 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| BS EN ISO 80601-2-69:2014 | Medical electrical equipment Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
| 09/30170496 DC : 0 | BS EN 60601-2-45 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES |
| EN ISO 7396-1:2016 | Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016) |
| 01/560793 DC : DRAFT FEB 2001 | IEC/DIS 60601-2-13 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ANAESTHETIC SYSTEMS |
| 15/30323081 DC : 0 | BS EN 80601-2-35 AMD1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| IEC 61669:2015 | Electroacoustics - Measurement of real-ear acoustical performance characteristics of hearing aids |
| BS EN 60601-2-64:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment |
| I.S. EN ISO 11073-10427:2018 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10427: DEVICE SPECIALIZATION - POWER STATUS MONITOR OF PERSONAL HEALTH DEVICES (ISO/IEEE 11073-10427:2018) |
| 08/30170297 DC : DRAFT MAR 2008 | BS EN 62083 - MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS |
| BS 5724-2.35(1997) : 1997 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR BLANKETS, PADS AND MATTRESSES INTENDED FOR HEATING AND MEDICAL USE |
| BS 5724-2.36(1997) : 1997 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR EQUIPMENT FOR EXTRA-CORPOREALLY INDUCED LITHOTRIPSY |
| 09/30203808 DC : 0 | BS EN ISO 80601-2-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| BS EN 80601-2-35 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| CEI EN 60601-2-18 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-18: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ENDOSCOPIC EQUIPMENT |
| CEI EN 60601-2-23 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-23: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT |
| CSA ISO/IEC 18000-1 : 2009 : R2014 | INFORMATION TECHNOLOGY - RADIO FREQUENCY IDENTIFICATION FOR ITEM MANAGEMENT - PART 1: REFERENCE ARCHITECTURE AND DEFINITION OF PARAMETERS TO BE STANDARDIZED |
| BS EN 60601-1-12:2015 | Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
| 16/30273296 DC : 0 | BS EN ISO 11608-4 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 4: NEEDLE-BASED INJECTION SYSTEMS CONTAINING ELECTRONICS |
| 03/103294 DC : DRAFT JAN 2003 | BS EN ISO 10651-6 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME CARE VENTILATORY SUPPORT DEVICES |
| BS EN 60601-2-30:2000 | Medical electrical equipment. Particular requirements for safety Particular requirements for safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
| UNE-EN 60645-6:2010 | Electroacoustics - Audiometric equipment -- Part 6: Instruments for the measurement of otoacoustic emissions |
| 15/30312454 DC : 0 | BS EN ISO 80601-2-56 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT |
| I.S. EN 60601-2-5:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC PHYSIOTHERAPY EQUIPMENT |
| BS EN 60645-1:2017 | Electroacoustics. Audiometric equipment Equipment for pure-tone and speech audiometry |
| BS EN 60601-2-13:2006 | Medical electrical equipment Particular requirements for the safety and essential performance of anaesthetic systems |
| 15/30323100 DC : 0 | BS EN 60601-2-19 AMD1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS - PROPOSED HORIZONTAL STANDARDS |
| 03/311987 DC : DRAFT AUG 2003 | BS EN 60601-2-27 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT |
| AAMI ID26:2004 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS |
| AAMI ID26 : 2004 : R2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS |
| AAMI DF80 : 2003 : R2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS [INCLUDING AUTOMATED EXTERNAL DEFIBRILLATORS] |
| BS EN 1865-2 : 2010 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
| CSA Z8185 : 2008(R2013) | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| CSA Z8185 : 2008 | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| NF EN 80601-2-30 : 2011 AMD 1 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
| EN 60601-2-63:2015 | Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
| CSA ISO/IEC 18000-2 : 2010 : R2015 | INFORMATION TECHNOLOGY - RADIO FREQUENCY IDENTIFICATION FOR ITEM MANAGEMENT - PART 2: PARAMETERS FOR AIR INTERFACE COMMUNICATIONS BELOW 135 KHZ |
| AAMI IEC 60601-2-47 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-47: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS |
| CSA Z10535 : 2003 | HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
| CSA Z9919 : 2007 : R2012 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| IEC TR 60930:2008 | Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems |
| CSA C22.2 No. 60601.2.5 : 2011 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC PHYSIOTHERAPY EQUIPMENT |
| UNE-EN ISO 80601-2-69:2015 | Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
| ISO 10650:2015 | Dentistry Powered polymerization activators |
| CSA C22.2 No. 60601.2.12 : 2003 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| CSA C22.2 No. 80601-2-58 : 2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
| ISO 18397:2016 | Dentistry Powered scaler |
| I.S. EN 60580:2000 | MEDICAL ELECTRICAL EQUIPMENT - DOSE AREA PRODUCT METERS |
| CEI EN 60601-2-62 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-62: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) EQUIPMENT |
| BS EN ISO 7396-1:2016 | Medical gas pipeline systems Pipeline systems for compressed medical gases and vacuum |
| AAMI IEC 60601-2-27:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT |
| BS EN ISO 80601-2-12:2011 | Medical electrical equipment Particular requirements for basic safety and essential performance of critical care ventilators |
| AAMI AT6 : 2013 | AUTOLOGOUS TRANSFUSION DEVICES |
| ISO 14708-3:2017 | Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| ISO 80601-2-70:2015 | Medical electrical equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment |
| I.S. EN 60601-2-64:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT |
| ISO 80601-2-74:2017 | Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
| CSA ISO/IEC TR 20017:14 (R2019) | Information technology - Radio frequency identification for item management - Electromagnetic interference impact of ISO/IEC 18000 interrogator emitters on implantable pacemakers and implantable cardioverter defibrillators (Adopted ISO/IEC TR 20017:2011, first edition, 2011-12-15) |
| BS EN ISO 11073-10427:2018 | Health informatics. Personal health device communication Device specialization. Power status monitor of personal health devices devices |
| NF EN 60601-2-62 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-62: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) EQUIPMENT |
| ISO 17966:2016 | Assistive products for personal hygiene that support users Requirements and test methods |
| ASTM E 1965 : 1998 : R2016 | Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature |
| DIN EN 60601-2-40 : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYGRAPHS AND EVOKED RESPONSE EQUIPMENT |
| NF EN 60601-2-54 : 2009 AMD 1 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
| NF EN 45502-2-3 : 2010 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
| CSA C22.2 No. 60601-2-19 : 2009 : R2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS |
| NF EN 60601 2-31 : 2008 AMD 1 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| I.S. EN 1865-2:2010 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
| IEC 60601-2-23:2011 | Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment |
| AAMI ES60601-1 : 2005 : INC : AMD 1 : 2012 : R201200 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| AAMI ES60601-1 : 2005 : INC : AMD 2 : 2012 : R201200 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| IEC 60645-1:2017 | Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry |
| ISO/TR 21730:2007 | Health informatics Use of mobile wireless communication and computing technology in healthcare facilities Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices |
| AAMI ES60601-1 : 2005 : R2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| NFPA 99 : 2018 | HEALTH CARE FACILITIES CODE |
| BS EN ISO 80601-2-13:2012+A2:2019 | Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| NF EN 60601-2-43 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
| BS EN ISO 10650-1:2005 | Dentistry. Powered polymerization activators Quartz tungsten halogen lamps |
| UNE-EN ISO 11197:2016 | Medical supply units (ISO 11197:2016) |
| IEC 60601-2-9:1996 | Medical electrical equipment - Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors |
| BS EN ISO 8359 : 2009 | OXYGEN CONCENTRATORS FOR MEDICAL USE - SAFETY REQUIREMENTS |
| BS EN ISO 11498:2000 | Dental handpieces. Dental low-voltage electric motors |
| ISO 8835-5:2004 | Inhalational anaesthesia systems Part 5: Anaesthetic ventilators |
| UNE-EN ISO 11252:2013 | Lasers and laser-related equipment - Laser device - Minimum requirements for documentation (ISO 11252:2013) |
| ISO/IEEE 11073-10418:2014 | Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor |
| EN 60601-2-65:2013 | Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
| UNE-EN ISO 11608-1:2015 | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) |
| UNE-EN 60601-2-25:2016 | Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
| BS EN ISO 22523:2006 | External limb prostheses and external orthoses. Requirements and test methods |
| BS ISO 7176-14:2008 | Wheelchairs Power and control systems for electrically powered wheelchairs and scooters. Requirements and test methods |
| IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV | Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography |
| I.S. EN ISO 11608-1:2015 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014) |
| I.S. EN ISO 10535:2006 | HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
| I.S. EN ISO 18777:2009 | TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
| CEN/TS 14507-1:2003 | Inhalational nitric oxide systems - Part 1: Delivery systems |
| EN 60601-2-25:2015 | Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
| IEC 60601-2-46:2016 | Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables |
| EN 60601-2-47:2015 | Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
| NF EN ISO 10651-6 : 2009 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| EN 60601-2-26:2015 | Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
| EN 60601-2-35:1996 | Medical electrical equipment - Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use |
| EN 12182:2012 | Assistive products for persons with disability - General requirements and test methods |
| EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| EN ISO 80601-2-13:2012 | Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011) |
| EN 80601-2-58:2015 | Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
| EN 60601-2-16:2015 | Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
| EN 60601-2-34:2014 | Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
| DIN EN ISO 21649:2010-01 | Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) |
| EN ISO 22523:2006 | External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) |
| EN 60645-5:2005 | Electroacoustics - Audiometric equipment - Part 5: Instruments for the measurement of aural acoustic impedance/admittance |
| NF EN 60601-2-26 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS |
| EN ISO 21647:2009 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005) |
| EN 13544-1:2007+A1:2009 | Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
| EN 61669:2016 | Electroacoustics - Measurement of real-ear acoustical performance characteristics of hearing aids |
| ONORM EN ISO 11608-4 : 2007 | PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS |
| NF EN 12182 : 2012 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
| DIN EN 60601-2-35 : 1997 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF BLANKETS, PADS AND MATTRESSES, INTENDED FOR HEATING IN MEDICAL USE |
| AAMI TIR26 : 2000 | VENTRICULAR ASSIST AND HEART REPLACEMENT SYSTEMS |
| DIN EN 60580:2001-12 | Medical electrical equipment - Dose area product meters (IEC 60580:2000); German version EN 60580:2000 |
| XP CEN/TS 14507-2 : 2003 XP | INHALATION NITRIC OXIDE SYSTEMS - PART 2: SUPPLY SYSTEMS |
| NF EN ISO 80601-2-61 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
| BS 5724-2.124(1998) : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS |
| BS EN 60601-2-25:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of electrocardiographs |
| 17/30338753 DC : 0 | BS ISO 80601-2-79 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-79: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY IMPAIRMENT |
| CSA ISO/IEC 18000-1 : 2009 | INFORMATION TECHNOLOGY - RADIO FREQUENCY IDENTIFICATION FOR ITEM MANAGEMENT - PART 1: REFERENCE ARCHITECTURE AND DEFINITION OF PARAMETERS TO BE STANDARDIZED |
| BS ISO 17966:2016 | Assistive products for personal hygiene that support users. Requirements and test methods |
| UNI EN 13976-2 : 2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| I.S. EN ISO 8359:2009 | OXYGEN CONCENTRATORS FOR MEDICAL USE - SAFETY REQUIREMENTS (ISO 8359:1996) |
| BS EN ISO 80601-2-72:2015 | Medical electrical equipment Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
| BS EN 60601-1-2:2015 | Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests |
| 17/30347827 DC : 0 | BS EN 60601-2-26 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPH |
| UNE-EN 60601-2-5:2016 | Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
| ANSI S3.6 : 2010 | SPECIFICATION FOR AUDIOMETERS |
| CEI EN 60601-2-40 : 1999 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT |
| AAMI IEC 60601-2-27:2011(R2016) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT |
| I.S. EN ISO 11498:1999 | DENTAL HANDPIECES - DENTAL LOW-VOLTAGE ELECTRICAL MOTORS |
| BS EN 60601-2-38:1997 | Medical electrical equipment. Particular requirements for safety Particular requirements for the safety of electrically operated hospital beds |
| BS EN 60601-2-26:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of electroencephalographs |
| ANSI/AAMI/IEC 60601-1-2:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| 15/30322732 DC : 0 | BS EN 60601-2-10 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-10: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF NERVE AND MUSCLE STIMULATORS - PROPOSED HORIZONTAL STANDARD |
| CEI EN 60731 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY |
| 06/30160373 DC : 0 | BS EN 60601-2-4 ED.3 - MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| I.S. EN 1865-3:2012 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
| BS ISO 11498 : 1997 AMD 10705 | DENTAL HANDPIECES - DENTAL LOW-VOLTAGE ELECTRIC MOTORS |
| OIML R 128 : 2000 | ERGOMETERS FOR FOOT CRANK WORK |
| 11/30206856 DC : 0 | BS EN 60601-1-8:2007/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
| BS EN 60645-6:2010 | Electroacoustics. Audiometric equipment Instruments for the measurement of otoacoustic emissions |
| 14/30284310 DC : 0 | BS ISO 10650 - DENTISTRY - POWERED POLYMERIZATION ACTIVATORS |
| BS EN 61223-3-4:2000 | Evaluation and routine testing in medical imaging departments Acceptance tests |
| DIN EN ISO 80601-2-72:2016-04 | Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015) |
| BS EN 60601-2-46:2011 | Medical electrical equipment Particular requirements for the basic safety and essential performance of operating tables |
| AAMI IEC 80601-2-30 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
| 14/30313972 DC : 0 | BS EN 60645-1 ED.4.0 - ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: EQUIPMENT FOR PURE-TONE AND SPEECH AUDIOMETRY |
| BS 5724-2.31(1995) : 1995 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| BS EN 60601-2-12:2006 | Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators |
| 14/30303965 DC : 0 | BS EN 60601-2-33/A2 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS |
| 15/30323076 DC : 0 | BS EN 60601-2-50 AMD1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT - PROPOSED HORIZONTAL STANDARD |
| BS ISO/IEC 18000-7:2014 | Information technology. Radio frequency identification for item management Parameters for active air interface communications at 433 MHz |
| 02/564924 DC : DRAFT NOV 2002 | ISO 21647 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| BS EN 60601-2-65:2013 | Medical electrical equipment Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
| 16/30312315 DC : 0 | BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| BS EN 60601-2-45 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES |
| 09/30181956 DC : DRAFT MAY 2009 | BS ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| ANSI Z80.11:2012 | OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING |
| UNI EN ISO 80601-2-12 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| PD ISO/TR 21730:2007 | Health informatics. Use of mobile wireless communication and computing technology in healthcare facilities. Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices |
| 15/30280904 DC : 0 | BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT |
| 04/30112949 DC : DRAFT APR 2004 | IEC 60825-8 ED.2 - SAFETY OF LASER PRODUCTS - PART 8: GUIDELINES FOR THE USE OF MEDICAL LASER EQUIPMENT |
| BS 5724-2.40(1998) : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - PART 2-40: ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT |
| 11/30227728 DC : 0 | BS EN 60601-2-65 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT |
| BS EN 80601-2-30 : 2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
| BS ISO/IEC 18000-1:2008 | Information technology. Radio frequency identification for item management Reference architecture and definition of parameters to be standardized |
| BS 5724-2.38(1997) : 1997 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS |
| BS EN 60601-2-5:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
| BS EN 45502-2-3:2010 | Active implantable medical devices Particular requirements for cochlear and auditory brainstem implant systems |
| BS 5724-2.204(1999) : 1999 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
| CEI EN 60645-1 : 2016 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: EQUIPMENT FOR PURE-TONE AUDIOMETRY |
| I.S. EN 60601-2-50:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT |
| PD IEC/TR 62296:2009 | Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements |
| CEI EN 62274 : 2005 | MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS |
| CSA C22.2 No. 60601-2-31 : 2009 : R2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| CSA C22.2 No. 80601-2-56 : 2012 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT |
| CSA Z10535 : 2003 : R2014 | HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
| AAMI IEC 60601-2-50 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT |
| CSA ISO/IEC 18000-2 : 2010 | INFORMATION TECHNOLOGY - RADIO FREQUENCY IDENTIFICATION FOR ITEM MANAGEMENT - PART 2: PARAMETERS FOR AIR INTERFACE COMMUNICATIONS BELOW 135 KHZ |
| CSA C22.2 NO. 60601-2-20:10 (R2019) | Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (Adopted IEC 60601-2-20:2009, second edition, 2009-02) | Appareils électromédicaux - Partie 2-20: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs de transport pour nouveau-nés (norme CEI 60601-2-20:2009 adoptée, deuxième édition, 2009-02) |
| NF EN 60601-1-11 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| CSA Z21647 : 2007 : R2012 : FR | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| NF EN 60601 2-20 : 2010 AMD 1 2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS |
| BS EN 60601-2-40:1998 | Medical electrical equipment. Particular requirements for safety Specification for electromyographs and evoked response equipment |
| CSA ISO/IEC 18000-7 : 2010 : R2015 | INFORMATION TECHNOLOGY - RADIO FREQUENCY IDENTIFICATION FOR ITEM MANAGEMENT - PART 7: PARAMETERS FOR ACTIVE AIR INTERFACE COMMUNICATIONS AT 433 MHZ |
| UNE-EN 60601-2-20:2010 | Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators |
| CAN/CSA-C22.2 NO. 80601-2-72:17 | Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted ISO 80601-2-72:2015, first edition, 2015-09-01, with Canadian deviations) |
| ISO/TS 10891:2009 | Freight containers — Radio frequency identification (RFID) — Licence plate tag |
| I.S. EN ISO 7396-1:2016 | MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016) |
| BS EN 60601-2-23:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment |
| UNE-EN ISO 20072:2013 | Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009) |
| I.S. EN 60601-2-26:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS |
| CSA C22.2 No. 60601-1-12 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT |
| UNE-EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
| CSA C22.2 No. 60601-2-64 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT |
| IEEE/ANSI C63.12-2015 | American National Standard Recommended Practice for Electromagnetic Compatibility Limits and Test Levels |
| CEI EN 60601-2-27 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT |
| EN 60601-2-50:2009/A1:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT (IEC 60601-2-50:2009/A1:2016) |
| ANSI/AAMI/IEC 80601-2-58:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
| CEI EN 60601-2-9 : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS |
| I.S. EN 60645-6:2010 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS |
| I.S. EN 60601-2-2:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH FREQUENCY SURGICAL EQUIPMENT AND HIGH FREQUENCY SURGICAL ACCESSORIES (IEC 60601-2-2:2009 (EQV)) |
| TR 102 626 : 1.1.1 | ELECTROMAGNETIC COMPATIBILITY AND RADIO SPECTRUM MATTERS (ERM); SYSTEM REFERENCE DOCUMENT; CITIZENS' BAND RADIO |
| I.S. EN 60601-2-47:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-47: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS |
| BS EN 60601-2-10:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
| AAMI IEC 60601-2-16 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEMODIALYSIS, HEMODIAFILTRATION AND HEMOFILTRATION EQUIPMENT |
| I.S. EN 60601-2-46:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-46: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OPERATING TABLES |
| UNI EN ISO 80601-2-55 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| I.S. EN 60601-2-36:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-36: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY |
| I.S. EN 60601-2-24:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS |
| BS EN 62464-1:2007 | Magnetic resonance equipment for medical imaging Determination of essential image quality parameters |
| CSA C22.2 No. 60601-2-20 : 2010FR | MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS |
| CEI EN 50174-3 : 2014 | INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 3: INSTALLATION PLANNING AND PRACTICES OUTSIDE BUILDINGS |
| CSA C22.2 No. 60601.2.49 : 2011 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT |
| NF EN ISO 80601-2-13 : 2013 AMD 1 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION |
| NF EN 60601 2-13 : 2007 AMD 1 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS |
| UNE-EN ISO 14457:2013 | Dentistry - Handpieces and motors (ISO 14457:2012) |
| CEI EN 60601-2-46 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-46: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OPERATING TABLES |
| CSA C22.2 No. 601.2.20 : 1992 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF TRANSPORT INCUBATORS |
| CSA C22.2 No. 601.2.31 : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| CSA C22.2 No. 60601.2.18 : 2011 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-18: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ENDOSCOPIC EQUIPMENT |
| I.S. EN 60601-2-65:2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT (IEC 60601-2-65:2012 (EQV)) |
| CSA C22.2 No. 60601-2-31:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| NF EN 60601 2-19 : 2009 AMD 11 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS |
| CSA C22.2 No. 60601.2.36 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-36: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY |
| NF EN 60601-1-12 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE THE EMERGENCY MEDICAL SERVICES ENVIRONMENT |
| ASTM E 1965 : 1998 : R2003 | Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature |
| ISO 14457:2017 | Dentistry — Handpieces and motors |
| IEC 60601-2-43:2010+AMD1:2017 CSV | Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures |
| IEC TR 62296:2009 | Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements |
| ANSI/AAMI/IEC TIR62354:2015 | GENERAL TESTING PROCEDURES FOR MEDICAL ELECTRICAL EQUIPMENT |
| AAMI TIR18:2010 | GUIDANCE ON ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICES IN HEALTHCARE FACILITIES |
| IEC 80601-2-30:2018 | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
| IEC TR 80001-2-1:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples |
| AAMI ES60601-1 : 2005 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| DIN EN ISO 8835-4:2009-07 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
| DIN EN 12182:2012-07 | Assistive products for persons with disability - General requirements and test methods |
| DIN EN ISO 8835-2:2009-08 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS |
| DIN EN ISO 17510-1:2009-07 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
| DIN EN ISO 18778:2009-08 | Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005) |
| DIN EN ISO 18777:2009-07 | TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
| BS EN ISO 10535:2006 | Hoists for the transfer of disabled persons. Requirements and test methods |
| UNE-EN ISO 80601-2-13:2013 | Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011) |
| BS EN ISO 8835-2:2009 | Inhalational anaesthesia systems Anaesthetic breathing systems (ISO 8835-2:2007) |
| IEC 60601-2-21:2009+AMD1:2016 CSV | Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers |
| IEC 60601-2-10:2012+AMD1:2016 CSV | Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and musclestimulators |
| DIN EN ISO 11608-4:2016-03 (Draft) | PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS |
| DIN EN ISO 10650-2:2007-11 | DENTISTRY - POWERED POLYMERIZATION ACTIVATORS - PART 2: LIGHT-EMITTING DIODE (LED) LAMPS |
| I.S. EN ISO 21649:2009 | NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
| I.S. EN ISO 17510-1:2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| I.S. EN ISO 18778:2009 | RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS |
| EN ISO 17510-1:2009 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
| DIN EN 12470-4:2001-02 | CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT |
| I.S. EN 12182:2012 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
| I.S. EN ISO 11252:2013 | LASERS AND LASER-RELATED EQUIPMENT - LASER DEVICE - MINIMUM REQUIREMENTS FOR DOCUMENTATION (ISO 11252:2013) |
| DIN EN ISO 10650-1:2006-01 | DENTISTRY - POWERED POLYMERIZATION ACTIVATORS - PART 1: QUARTZ TUNGSTEN HALOGEN LAMPS |
| I.S. EN ISO 8185:2009 | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| DIN EN ISO 10651-2:2011-06 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| I.S. EN 60601-2-33:2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS |
| I.S. EN ISO 18779:2005 | MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS |
| DIN EN ISO 8359:2009-08 | OXYGEN CONCENTRATORS FOR MEDICAL USE - SAFETY REQUIREMENTS |
| BIS IS/ISO 14708-3 : 2008 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS |
| VDE 0750-2-64 : 2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT |
| NF EN ISO 18778 : 2009 | RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS |
| DIN EN 60601-2-64 : 2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT |
| ASTM E 1965 : 1998 | Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature |
| BS EN 60601-2-2 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH FREQUENCY SURGICAL EQUIPMENT AND HIGH FREQUENCY SURGICAL ACCESSORIES |
| CSA C22.2 No. 60601-1-11 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| BS EN 1865-3 : 2012 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
| AAMI IEC 60601-2-21 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS |
| BS EN 60601-2-34:2014 | Medical electrical equipment Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
| BS EN ISO 10650:2015 | Dentistry. Powered polymerization activators |
| IEC TR 60601-4-2:2016 | Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
| 07/30165869 DC : 0 | BS ISO/IEC 18000-1 - INFORMATION TECHNOLOGY - RADIO FREQUENCY IDENTIFICATION FOR ITEM MANAGEMENT - PART 1: REFERENCE ARCHITECTURE AND DEFINITION OF PARAMETERS TO BE STANDARDIZED |
| NF EN 60601-2-64 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT |
| ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| 09/30197590 DC : 0 | BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| 16/30325024 DC : DRAFT JULY 2016 | BS EN 60601-2-49 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT |
| CEI EN 60601-2-24 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS |
| 14/30296572 DC : 0 | BS EN 60601-1-11 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| 11/30215841 DC : 0 | BS EN ISO 14457 - DENTISTRY - HAND PIECES AND MOTORS |
| DIN EN 1865-2:2015-05 | Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher (includes Amendment A1:2015) |
| EN ISO 10650:2015 | Dentistry - Powered polymerization activators (ISO 10650:2015) |
| ISO 7176-14:2008 | Wheelchairs Part 14: Power and control systems for electrically powered wheelchairs and scooters Requirements and test methods |
| 15/30300279 DC : 0 | BS ISO 80601-2-74 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-74: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY HUMIDIFYING EQUIPMENT |
| EN ISO 11197:2016 | Medical supply units (ISO 11197:2016) |
| BS EN 60601-2-62:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment |
| SAE AS 8059 : 2012 | CARRY-ON PORTABLE OXYGEN CONCENTRATORS |
| BS EN 60601-2-18:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of endoscopic equipment |
| CSA C22.2 No. 60601.2.23 :2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-23: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT |
| I.S. EN ISO 8835-2:2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS |
| CSA C22.2 No. 60601.2.9 : 0 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS |
| ANSI/AAMI/IEC 60601-2-47:2012(R2016) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-47: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS |
| 16/30319034 DC : 0 | BS EN 60601-2-2 ED 6.0 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH FREQUENCY SURGICAL EQUIPMENT AND HIGH FREQUENCY SURGICAL ACCESSORIES |
| UNI EN ISO 11073-30400 : 2013 | HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30400: INTERFACE PROFILE - CABLED ETHERNET |
| 12/30260552 DC : 0 | BS EN 50174-3:201X - INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 3: INSTALLATION PLANNING AND PRACTICES OUTSIDE BUILDINGS |
| UNI EN ISO 80601-2-69 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT |
| 13/30282677 DC : 0 | BS EN 61669 ED.2 - ELECTROACOUSTICS - MEASUREMENT OF REAL-EAR ACOUSTICAL PERFORMANCE CHARACTERISTICS OF HEARING AIDS |
| BS EN 60601-2-43:2010 | Medical electrical equipment Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures |
| CEI EN 60580 : 2001 | MEDICAL ELECTRICAL EQUIPMENT DOSE AREA PRODUCT METERS |
| BS 5724-2.202(1997) : 1997 + A2 2009 | LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS |
| AAMI EC13 : 2002 | CARDIAC MONITORS, HEART RATE METERS AND ALARMS |
| BS ISO/IEC 18000-2:2009 | Information technology. Radio frequency identification for item management Parameters for air interface communications below 135 kHz |
| BS ISO 16142-1:2016 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| EN IEC 60601-2-2:2018 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| 02/564070 DC : DRAFT SEP 2002 | BS EN 60601-2-17 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE SAFETY OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT |
| 08/30187614 DC : DRAFT SEP 2008 | BS ISO/IEC 18000-7 - INFORMATION TECHNOLOGY AIDC TECHNIQUES - RADIO FREQUENCY IDENTIFICATION FOR ITEM MANAGEMENT - AIR INTERFACE - PART 7: PARAMETERS FOR ACTIVE AIR INTERFACE COMMUNICATIONS AT 433 MHZ |
| 12/30253654 DC : 0 | BS ISO/IEC 18000-7 - INFORMATION TECHNOLOGY - RADIO FREQUENCY IDENTIFICATION FOR ITEM MANAGEMENT - PART 7: PARAMETERS FOR ACTIVE AIR INTERFACE COMMUNICATIONS AT 433 MHZ |
| I.S. EN IEC 60601-2-2:2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH FREQUENCY SURGICAL EQUIPMENT AND HIGH FREQUENCY SURGICAL ACCESSORIES |
| 16/30342399 DC : 0 | BS EN 60601-2-43:2010/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
| 15/30328565 DC : 0 | BS EN 60645-1 ED4.0 - ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: EQUIPMENT FOR PURE-TONE AND SPEECH AUDIOMETRY |
| AAMI IEC 60601-2-25 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-25: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHS |
| UNE-EN 55011:2011 | Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
| 16/30349981 DC : 0 | BS EN 80601-2-59 ED 2.0 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-59: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SCREENING THERMOGRAPHS FOR HUMAN FEBRILE TEMPERATURE SCREENING |
| NF EN 60601-1 : 2007-01 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| NF EN 60601-2-65 : 2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT |
| 16/30340242 DC : 0 | BS IEC 60601-2-4 ED3.0 AMD 1 - EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| CSA Z18779 : 2008 : R2013 | MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS |
| UNI EN ISO 20072 : 2013 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS |
| 07/30173584 DC : 0 | BS EN 60645-7 - ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 7: INSTRUMENTS FOR THE MEASUREMENT OF AUDITORY EVOKED POTENTIALS |
| CEI EN 60601-2-25 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-25: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHS |
| 03/106547 DC : DRAFT APR 2003 | ISO 10650 - DENTISTRY - POWERED POLYMERIZATION ACTIVATORS |
| AAMI DF80:2003 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS [INCLUDING AUTOMATED EXTERNAL DEFIBRILLATORS] |
| BS EN ISO 11073-10418:2014 | Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor |
| 06/30145777 DC : DRAFT FEB 2006 | ISO 10650-2 - DENTISTRY - POWERED POLYMERIZATION ACTIVATORS - PART 2: LIGHT-EMITTING DIODE (LED) LAMPS |
| AAMI ID26 : 2004 : R2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS |
| CSA Z9919 :2007 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| I.S. EN 60601-2-62:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-62: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) EQUIPMENT |
| CSA C22.2 No. 80601-2-30 : 2010 : INC : COR 1 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
| VDE 0750-2-40 : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT |
| I.S. EN 50637:2017 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS FOR CHILDREN |
| IEEE C95.1-2345-2014 | IEEE Standard for Military Workplaces--Force Health Protection Regarding Personnel Exposure to Electric, Magnetic, and Electromagnetic Fields, 0 Hz to 300 GHz |
| CSA C22.2 No. 80601-2-30 : 2010FR | MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
| UNE-EN ISO 80601-2-56:2013 | Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009) |
| CSA C22.2 No. 80601-2-30 : 2010 : R2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
| CEI EN 60601-2-12 : 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| ISO/IEC 18000-2:2009 | Information technology — Radio frequency identification for item management — Part 2: Parameters for air interface communications below 135 kHz |
| BS EN 60731:2012 | Medical electrical equipment. Dosimeters with ionization chambers as used in radiotherapy |
| BS EN 60601-2-49:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| AAMI HE75 : 2009 | HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
| BS EN 55011 : 2016 | INDUSTRIAL, SCIENTIFIC AND MEDICAL EQUIPMENT - RADIO-FREQUENCY DISTURBANCE CHARACTERISTICS - LIMITS AND METHODS OF MEASUREMENT |
| EN 80601-2-35:2009/A1:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE (IEC 80601-2-35:2009/A1:2016) |
| NF EN 60601-2-63 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT |
| I.S. EN 80601-2-30:2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
| I.S. EN 60601-2-63:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRAORAL X-RAY EQUIPMENT |
| I.S. EN 60645-1:2017 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: EQUIPMENT FOR PURE-TONE AND SPEECH AUDIOMETRY |
| I.S. EN 60601-1-12:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT |
| AAMI ISO 14708-5 : 2010 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES |
| BS EN 60601-2-19 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS (IEC 60601-2-19:2009) |
| I.S. EN 60601-2-20:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS |
| AAMI/IEC TIR62296:2009 | |
| I.S. EN 60601-1:2006&A1:2013&AC:2014&A12:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| I.S. EN 50174-3:2013 | INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 3: INSTALLATION PLANNING AND PRACTICES OUTSIDE BUILDINGS |
| I.S. EN 62083:2009 | MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS |
| ISO/IEC 18000-1:2008 | Information technology Radio frequency identification for item management Part 1: Reference architecture and definition of parameters to be standardized |
| ISO 14708-7:2013 | Implants for surgery Active implantable medical devices Part 7: Particular requirements for cochlear implant systems |
| BS EN 80601-2-58:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
| I.S. EN 60601-2-16:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT |
| DIN EN ISO 7396-1:2016-09 | MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016) |
| I.S. EN ISO 11197:2016 | MEDICAL SUPPLY UNITS (ISO 11197:2016) |
| I.S. EN 60601-2-18:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-18: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ENDOSCOPIC EQUIPMENT |
| EN 60601-2-40:1998 | Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment |
| IEC TR 62354:2014 | General testing procedures for medical electrical equipment |
| CSA C22.2 No. 60601.2.18 : 20111 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-18: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ENDOSCOPIC EQUIPMENT |
| EN 60601-2-43:2010/A1:2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES (IEC 60601-2-43:2010/A1:2017) |
| PD IEC/TR 60601-4-3:2015 | Medical electrical equipment Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements |
| I.S. EN ISO 80601-2-13:2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION (ISO 80601-2-13:2011) |
| PREN 50174-3 : DRAFT 2012 | INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 3: INSTALLATION PLANNING AND PRACTICES OUTSIDE BUILDINGS |
| ASTM F 1690 : 1996 : R2004 | Standard Specification for Humidifiers for Medical Use—Part 1: General Requirements for Active Humidification Systems (Withdrawn 2013) |
| I.S. EN ISO 20072:2013 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
| CSA C22.2 No. 60601-2-62 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-62: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) EQUIPMENT |
| CSA Z8835.2 : 2008 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS FOR ADULTS |
| ASTM F 1456 : 2001 | Standard Specification for Minimum Performance and Safety Requirements for Capnometers |
| EN ISO 80601-2-61:2011 | Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011) |
| EN ISO 80601-2-55:2018 | Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018) |
| I.S. EN 60601-1-2:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| ISO/IEC 18000-7:2014 | Information technology Radio frequency identification for item management Part 7: Parameters for active air interface communications at 433 MHz |
| NF EN ISO 11197 : 2016 | MEDICAL SUPPLY UNITS |
| I.S. EN 60601-2-19:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS |
| IEEE/ANSI C63.15-2010 | American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment |
| DIN EN ISO 22523:2007-04 | External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) |
| NF EN 60601-2-46 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-46: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OPERATING TABLES |
| DIN EN 12470-4:2009-11 | CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT |
| DIN EN ISO 10651-6:2011-06 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| DIN EN 13544-1:2009-12 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| DIN EN ISO 11608-1:2015-04 | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) |
| BS EN ISO 9919:2009 | Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
| ISO 18779:2005 | Medical devices for conserving oxygen and oxygen mixtures Particular requirements |
| IEC 60645-6:2009 | Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions |
| ISO 8835-2:2007 | Inhalational anaesthesia systems Part 2: Anaesthetic breathing systems |
| BS EN ISO 21649:2009 | Needle-free injectors for medical use. Requirements and test methods |
| BS EN 60601-2-16:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
| BS EN ISO 11196:1997 | Anaesthetic gas monitors |
| ISO 10650-2:2007 | Dentistry Powered polymerization activators Part 2: Light-emitting diode (LED) lamps |
| ISO 10651-2:2004 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients |
| ISO 80601-2-69:2014 | Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
| BS EN 12470-5:2003 | Clinical thermometers Performance of infra-red ear thermometers (with maximum device) |
| ISO 21649:2006 | Needle-free injectors for medical use — Requirements and test methods |
| IEC 60645-5:2004 | Electroacoustics - Audiometric equipment - Part 5: Instruments for the measurement of aural acoustic impedance/admittance |
| 04/30106146 DC : DRAFT MARCH 2004 | BS EN 60601-1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| UNE-EN 60601-1:2008 | Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance |
| UNE-EN 60601-2-54:2010 | Medical electrical equipment -- Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
| EN ISO 80601-2-69:2014 | Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
| I.S. EN 13544-1:2007 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| EN 60601-1-12:2015 | Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
| EN 60601-2-4:2011 | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| EN ISO 8185:2009 | Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007) |
| UNI EN 12470-4 : 2009 | CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT |
| UNI EN ISO 11252 : 2013 | LASERS AND LASER-RELATED EQUIPMENT - LASER DEVICE - MINIMUM REQUIREMENTS FOR DOCUMENTATION |
| UNI EN ISO 21647 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| CSA Z8835.4 : 2006 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
| UNI EN ISO 10651-2 : 2009 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR- DEPENDENT PATIENTS |
| UNI EN ISO 8835-5 : 2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHETIC VENTILATORS |
| UNI EN ISO 18777 : 2009 | TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
| I.S. EN ISO 11608-4:2007 | PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS |
| EN ISO 9919:2009 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005) |
| UNI EN ISO 9919 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| UNI EN 13544-1 : 2009 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| UNI CEI EN 45502-2-3 : 2010 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
| UNI EN ISO 10651-6 : 2009 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| UNI EN ISO 18778 : 2009 | RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS |
| UNI EN 12182 : 2012 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
| UNI EN ISO 8185 : 2009 | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| UNI EN ISO 8359 : 2012 | OXYGEN CONCENTRATORS FOR MEDICAL USE - SAFETY REQUIREMENTS |
| UNI EN ISO 8835-4 : 2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
| UNI EN 794-1 : 2009 | LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS |
| CSA C22.2 No. 60601.2.5:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC PHYSIOTHERAPY EQUIPMENT |
| I.S. EN ISO 80601-2-56:2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT (ISO 80601-2-56:2017) |
| 13/30271473 DC : 0 | BS EN 80601-2-58 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
| ANSI/AAMI HA60601-1-11:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| DD CEN/TS 14507-1:2003 | Inhalational nitric oxide systems Delivery systems |
| ISO 11197:2016 | Medical supply units |
| ISO 7767:1997 | Oxygen monitors for monitoring patient breathing mixtures — Safety requirements |
| 12/30159217 DC : 0 | BS EN 60601-1-2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| DIN EN ISO 20072:2013-10 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
| PREN 13976-2 : DRAFT 2016 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| NF EN 60601-2-4 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| NF EN 1865-2 : 2011 + A1 2016 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHERS |
| BS EN ISO 20072:2013 | Aerosol drug delivery device design verification. Requirements and test methods |
| 14/30281087 DC : 0 | BS EN 80601-2-71 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-71: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF FUNCTIONAL NEAR-INFRARED SPECTROSCOPY (NIRS) EQUIPMENT |
| I.S. EN 60601-2-10:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-10: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF NERVE AND MUSCLE STIMULATORS |
| 08/30192448 DC : DRAFT DEC 2008 | BS ISO 14708-5 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES |
| NF EN ISO 80601-2-72 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| UNI EN ISO 21649 : 2009 | NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
| I.S. EN ISO 21647:2009 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| 14/30302072 DC : 0 | BS EN 80601-2-71 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-71: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF FUNCTIONAL NEAR-INFRARED SPECTROSCOPY (NIRS) EQUIPMENT |
| 11/30243761 DC : 0 | BS ISO 14708-7 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS |
| I.S. EN 62274:2005 | MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS |
| I.S. EN ISO 9919:2009 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| UNI EN ISO 8835-2 : 2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS |
| 17/30338756 DC : 0 | BS ISO 80601-2-80 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-80: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY INSUFFICIENCY |
| 13/30264413 DC : 0 | BS EN ISO 80601-2-72 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| 04/30088533 DC : DRAFT MARCH 2004 | BS EN ISO 8185 - RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| BS EN ISO 18397:2016 | Dentistry. Powered scaler |
| I.S. EN ISO 10650-2:2007 | DENTISTRY - POWERED POLYMERIZATION ACTIVATORS - PART 2: LIGHT-EMITTING DIODE (LED) LAMPS |
| 05/30134824 DC : 0 | EN 50447 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR HEART-LUNG MACHINES (HLM) |
| 12/30245174 DC : 0 | BS EN 60601-1-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT |
| BS EN 60601-2-21 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS (IEC 60601-2-21:2009) |
| I.S. EN ISO 18397:2016 | DENTISTRY - POWERED SCALER (ISO 18397:2016) |
| PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
| 09/30194820 DC : 0 | BS EN 60731 - MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY |
| PD IEC/TR 80001-2-1:2012 | Application of risk management for IT-networks incorporating medical devices Step-by-step risk management of medical IT-networks. Practical applications and examples |
| I.S. EN 60601-2-27:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT |
| BS EN ISO 11073-30400:2012 | Health informatics. Point-of-care medical device communication Interface profile. Cabled Ethernet |
| BS 5724-2.44(1999) : 1999 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY |
| BS ISO 18190:2016 | Anaesthetic and respiratory equipment. General requirements for airways and related equipment |
| 16/30333925 DC : 0 | BS EN 13976-2 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| 13/30267930 DC : 0 | BS EN 60601-2-45 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES |
| 07/30173580 DC : 0 | BS EN 60645-6 - ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS |
| 16/30310674 DC : 0 | BS EN ISO 14457 - DENTISTRY - HANDPIECES AND MOTORS |
| 12/30264287 DC : 0 | BS EN 60118-13 ED.4 - ELECTROACOUSTICS - HEARING AIDS - PART 13: ELECTROMAGNETIC COMPATABILITY (EMC) (REVISION OF IEC 60118-13: 2011) |
| IEC 60601-2-2:2017 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| 14/30290166 DC : 0 | BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| 13/30233325 DC : 0 | BS EN 45502-1 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| ANSI/AAMI/IEC TIR80001-2-1:2012 | APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-1: STEP BY STEP RISK MANAGEMENT OF MEDICAL IT-NETWORKS - PRACTICAL APPLICATIONS AND EXAMPLES |
| CEI EN 60601-2-4 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| 14/30257546 DC : 0 | BS ISO 17966 - ASSISTIVE PRODUCTS FOR PERSONAL HYGIENE THAT SUPPORT USERS - REQUIREMENTS AND TEST METHODS |
| DD CEN/TS 14507-2:2003 | Inhalational nitric oxide systems Supply systems |
| BS EN 62274:2005 | Medical electrical equipment. Safety of radiotherapy record and verify systems |
| AAMI IEC 60601-2-4 : 2010 : R2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| IEC 80601-2-49:2018 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors |
| 08/30149952 DC : DRAFT MAY 2008 | BS EN 60601-2-54 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
| 09/30189968 DC : DRAFT JAN 2009 | BS EN 13544-1 AMD1 - RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| PREN ISO 80601-2-55 : DRAFT 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| 12/30244415 DC : DRAFT APR 2012 | BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| BS 5724-2.18(1997) : 1997 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ENDOSCOPIC EQUIPMENT |
| 08/30176438 DC : DRAFT JAN 2008 | BS EN 60645-1 - ELECTRO ACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: PURE-TONE AUDIOMETERS |
| DIN EN 1865-3:2015-05 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
| NF EN 60601-2-2 : 2009 AMD 11 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH FREQUENCY SURGICAL EQUIPMENT AND HIGH FREQUENCY SURGICAL ACCESSORIES |
| 15/30323096 DC : 0 | BS EN 60601-2-20 AMD1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS |
| BS EN 60645-5:2005 | Electroacoustics. Audiometric equipment Instruments for the measurement of aural acoustic impedance/admittance |
| CEI EN 62083 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS |
| GOST R IEC 60601-2-44 : 2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY |
| 03/103293 DC : DRAFT JAN 2003 | BS EN ISO 10651-2 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| 17/30341818 DC : 0 | BS EN 60601-2-54 ED 1.0/A2 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
| 03/111581 DC : DRAFT JULY 2003 | BS EN ISO 18778 - INFANT MONITORS - PARTICULAR REQUIREMENTS |
| 07/30145258 DC : 0 | BS ISO 20072 - AEROSOL DRUG DELIVERY DEVICES DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS |
| 12/30253196 DC : 0 | BS EN 60601-2-36 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-36: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTRACORPOREALLY INDUCED LITHOTRIPSY |
| 01/561640 DC : DRAFT APR 2001 | BS EN ISO 8835-4 - INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
| NF EN ISO 80601-2-12 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| CSA ISO 27427 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| CAN/CSA-Z18777-08 (R2018) | Transportable Liquid Oxygen Systems for Medical Use - Particular Requirements (Adopted ISO 18777:2005, first edition, 2005-02-15, with Canadian deviations) |
| AAMI ISO 14708-4 : 2008 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS |
| 17/30357890 DC : 0 | BS ISO 20495 - TRADITIONAL CHINESE MEDICINE - SKIN ELECTRICAL RESISTANCE MEASUREMENT DEVICE |
| BS EN 60601-2-4:2011 | Medical electrical equipment Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| I.S. EN 60601-2-4:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| IEEE C95.1-2005 | IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz |
| CSA Z21647:2007 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| CSA Z10651.2: 2006 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| CSA Z21647 : 2007 : R2012 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| CSA ISO/IEC 18000-7 : 2010 | INFORMATION TECHNOLOGY - RADIO FREQUENCY IDENTIFICATION FOR ITEM MANAGEMENT - PART 7: PARAMETERS FOR ACTIVE AIR INTERFACE COMMUNICATIONS AT 433 MHZ |
| ANSI/AAMI/ISO 14708-3:2017 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS |
| CSA Z18777 : 2008 | TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
| ANSI Z80.11 : 2012 : R2017 | OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING |
| I.S. EN 55011:2016 | INDUSTRIAL, SCIENTIFIC AND MEDICAL EQUIPMENT - RADIO-FREQUENCY DISTURBANCE CHARACTERISTICS - LIMITS AND METHODS OF MEASUREMENT |
| ISO 80601-2-56:2017 | Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement |
| ISO 80601-2-67:2014 | Medical electrical equipment Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment |
| CSA C22.2 No. 60601-2-19 : 2009 : INC : COR 1 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS |
| CSA Z8835.5 : 2006 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHETIC VENTILATORS |
| OVE/ONORM EN 60601-2-31 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE (IEC 60601-2-31:2008 + A1:2011) |
| IEEE/ANSI C63.18-2014 | American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters |
| CEI EN 60601-2-16 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT |
| I.S. EN 60601-2-49:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT |
| CAN/CSA-C22.2 NO. 80601-2-67:17 | Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen conserving equipment (Adopted ISO 80601-2-67:2014, first edition, 2014-06-01, with Canadian deviations) |
| BS EN 60601-2-50 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT (IEC 60601-2-50:2009) |
| EN 50174-3:2013/A1:2017 | INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 3: INSTALLATION PLANNING AND PRACTICES OUTSIDE BUILDINGS |
| I.S. EN ISO 80601-2-72:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015) |
| CEI EN 55011 : 2017 | INDUSTRIAL, SCIENTIFIC AND MEDICAL EQUIPMENT - RADIO-FREQUENCY DISTURBANCE CHARACTERISTICS - LIMITS AND METHODS OF MEASUREMENT |
| I.S. EN ISO 11073-10418:2014 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01) |
| I.S. EN 60601-2-34:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-34: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT |
| NF EN 60601 2-47 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-47: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS |
| I.S. EN 60601-2-40:1999 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT |
| UNI EN ISO 17510-1 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| ISO 14708-4:2008 | Implants for surgery Active implantable medical devices Part 4: Implantable infusion pumps |
| NF EN 60601-2-40 : 2000 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENTS |
| CSA C22.2 No. 60601.2.27:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT |
| CSA C22.2 No. 60601-2-20 : 2010(R2014) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS |
| ASTM F 1690 : 1996 | Standard Specification for Humidifiers for Medical Use-Part 1 General Requirements for Active Humidification Systems |
| UNE-EN ISO 7396-1:2016 | Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016) |
| ISO 80601-2-55:2018 | Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| DIN EN ISO 10650:2016-02 | DENTISTRY - POWERED POLYMERIZATION ACTIVATORS (ISO 10650:2015) |
| BS EN ISO 11197:2009 | Medical supply units |
| ISO 7396-1:2016 | Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum |
| I.S. EN 60601-2-25:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-25: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHS |
| I.S. EN ISO 80601-2-12:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO 80601-2-12:2011/COR 1:2011) |
| I.S. EN 60601-2-43:2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
| I.S. EN 60601-2-12:2006 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| I.S. EN 60601-2-44:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY |
| IEC 80601-2-59:2017 | Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening |
| I.S. EN 13976-2:2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| I.S. EN 60731:2012 | MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY (IEC 60731:2011 (EQV)) |
| EN 60601-2-44:2009/A2:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (IEC 60601-2-44:2009/A2:2016) |
| IEC 60601-2-31:2008+AMD1:2011 CSV | Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source |
| UNE-EN 60645-1:2015 | Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone audiometry |
| ISO 80601-2-12:2011 | Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| DIN EN ISO 8835-5:2009-07 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHESIA VENTILATORS |
| IEC 60645-1:2017 RLV | Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry |
| BS EN ISO 8185:2007 | Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems |
| BS EN 60601-1 : 2006 | MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| BS EN ISO 17510-1:2009 | Sleep apnoea breathing therapy Sleep apnoea breathing therapy equipment |
| ISO 18778:2005 | Respiratory equipment — Infant monitors — Particular requirements |
| BS EN 13976-2:2011 | Rescue systems. Transportation of incubators System requirements |
| IEC 62274:2005 | Medical electrical equipment - Safety of radiotherapy record and verify systems |
| IEC 62464-1:2007 | Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters |
| IEC 60601-2-50:2009+AMD1:2016 CSV | Medical electrical equipment - Part 2-50: Particular requirementsfor the basic safety and essential performance of infant phototherapy equipment |
| EN 60580:2000 | Medical electrical equipment - Dose area product meters |
| BS EN ISO 10651-6:2009 | Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home-care ventilatory support devices |
| ISO 9919:2005 | Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
| IEC 80601-2-58:2014+AMD1:2016 CSV | Medical electrical equipment - Part 2-58: Particular requirementsfor the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
| BS EN 13544-1 : 2007 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| ISO 80601-2-72:2015 | Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
| BS EN ISO 18778:2009 | Respiratory equipment. Infant monitors. Particular requirements |
| BS EN ISO 11608-4:2007 | Pen-injectors for medical use Requirements and test methods for electronic and electromechanical pen-injectors |
| ISO 11498:1997 | Dental handpieces Dental low-voltage electrical motors |
| ISO 20072:2009 | Aerosol drug delivery device design verification Requirements and test methods |
| IEC 60601-2-33:2010+AMD1:2013+AMD2:2015 CSV | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
| IEC 60731:2011+AMD1:2016 CSV | Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy |
| IEC 60580:2000 | Medical electrical equipment - Dose area product meters |
| UNE-EN 60601-2-49:2016 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| IEC 60601-2-45:2011+AMD1:2015 CSV | Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices |
| 00/565497 DC : DRAFT DEC 2000 | BS IEC 60601-1 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY AND ESSENTIAL PERFORMANCE |
| ISO 10650-1:2004 | Dentistry Powered polymerization activators Part 1: Quartz tungsten halogen lamps |
| BS EN 12470-4 : 2001 | CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT |
| ISO 11608-4:2006 | Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors |
| ISO 10535:2006 | Hoists for the transfer of disabled persons Requirements and test methods |
| IEC 60601-2-62:2013 | Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment |
| IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests |
| IEC 60601-2-47:2012 | Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
| ISO 18777:2005 | Transportable liquid oxygen systems for medical use — Particular requirements |
| BS EN ISO 10651-2:2004 | Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home care ventilators for ventilator-dependent patients |
| ISO 10651-6:2004 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices |
| ISO 11252:2013 | Lasers and laser-related equipment — Laser device — Minimum requirements for documentation |
| IEC 60601-2-20:2009+AMD1:2016 CSV | Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transportincubators |
| BS EN 740:1999 | Anaesthetic workstations and their modules. Particular requirements |
| ISO/IEEE 11073-30400:2012 | Health informatics — Point-of-care medical device communication — Part 30400: Interface profile — Cabled Ethernet |
| IEC 60601-2-24:2012 | Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
| ISO 22523:2006 | External limb prostheses and external orthoses — Requirements and test methods |
| IEC 60601-2-36:2014 | Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy |
| IEC 60601-2-30:1999 | Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
| ISO 80601-2-13:2011 | Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| ISO 11608-1:2014 | Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems |
| ISO 8835-4:2004 | Inhalational anaesthesia systems Part 4: Anaesthetic vapour delivery devices |
| UNE-EN 45502-2-3:2010 | Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
| BS EN ISO 11252:2013 | Lasers and laser-related equipment. Laser device. Minimum requirements for documentation |
| ISO 21647:2004 | Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| BS EN ISO 10650-2:2007 | Dentistry. Powered polymerization activators Light-emitting diode (LED) lamps |
| UNE-EN 62083:2010 | Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
| ISO 8359:1996 | Oxygen concentrators for medical use Safety requirements |
| NF EN ISO 17510-1 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| BS EN 60601-2-33 : 2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS |
| I.S. EN 60601-2-65:2013/A1:2020 | Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intraoral X-ray equipment (IEC 60601-2-65:2012/A1:2017) |
| UNI EN ISO 80601-2-13 : 2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION |
| IEC 62083:2009 | Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
| UNE-EN 60601-2-18:2016 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| EN 60601-2-31:2008/A1:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| BS EN 12182:2012 | Assistive products for persons with disability. General requirements and test methods |
| EN 60601-2-9:1996/corrigendum:1996 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS |
| EN 1865-2:2010+A1:2015 | Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher |
| EN ISO 80601-2-72:2015 | Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015) |
| EN ISO 10651-2:2009 | Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004) |
| EN ISO 21649:2009 | Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) |
| IEC 80601-2-30:2018 RLV | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
| EN ISO 8835-4:2009 | Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004) |
| EN ISO 10651-6:2009 | Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004) |
| EN ISO 8835-5:2009 | Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004) |
| EN ISO 18779:2005 | Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005) |
| EN 45502-2-3:2010 | Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
| EN ISO 18777:2009 | Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005) |
| EN 1865-3:2012+A1:2015 | Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher |
| EN ISO 20072:2013 | Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009) |
| EN 12470-4:2000+A1:2009 | Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement |
| EN ISO 11073-30400:2012 | Health informatics - Point-of-care medical device communication - Part 30400: Interface profile - Cabled Ethernet (ISO 11073-30400:2012) |
| EN ISO 18778:2009 | Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005) |
| EN ISO 11608-1:2015 | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) |
| EN ISO 11498:1999 | Dental handpieces - Dental low-voltage electrical motors (ISO 11498:1997) |
| EN 794-1:1997+A2:2009 | Lung ventilators - Part 1: Particular requirements for critical care ventilators |
| EN ISO 11608-4:2007 | Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006) |
| EN ISO 10650-1:2005 | Dentistry - Powered polymerization activators - Part 1: Quartz tungsten halogen lamps (ISO 10650-1:2004) |
| EN ISO 10650-2:2007 | Dentistry - Powered polymerization activators - Part 2: Light-emitting diode (LED) lamps (ISO 10650-2:2007) |
| EN ISO 18397:2016 | Dentistry - Powered scaler (ISO 18397:2016) |
| EN ISO 8835-2:2009 | Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007) |
| I.S. EN ISO 10650:2015 | DENTISTRY - POWERED POLYMERIZATION ACTIVATORS (ISO 10650:2015) |
| I.S. EN ISO 80601-2-61:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
| CAN/CSA-C22.2 NO. 60601-2-19-09 (R2018) | Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (Adopted IEC 60601-2-19:2009, second edition, 2009-02) | Appareils électromédicaux - Partie 2-19: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs pour nouveau- nés (norme CEI 60601-2-19:2009 adoptée, deuxième édition, 2009-02) |
| ISO 80601-2-61:2017 | Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
| CSA C22.2 No. 60601.2.24 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS |
| DIN EN ISO 18397:2016-09 | DENTISTRY - POWERED SCALER (ISO 18397:2016) |
| BS EN 50637:2017 | Medical electrical equipment. Particular requirements for the basic safety and essential performance of medical beds for children |
| BS EN 60601-2-35:1997 | Medical electrical equipment. Particular requirements for safety Specification for blankets, pads and mattresses intended for heating in medical use |
| CEI EN 60601-2-47 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-47: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS |
| 15/30323090 DC : 0 | BS EN 60601-2-21 AMD1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS - PROPOSED HORIZONTAL STANDARD |
| I.S. EN 60601-2-45:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES |
| 06/30159274 DC : 0 | BS EN 80601-2-30 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED TYPE NON-INVASIVE SPHYGMOMANOMETERS |
| CEI EN 60601-2-5 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC PHYSIOTHERAPY EQUIPMENT |
| I.S. EN ISO 10650-1:2005 | DENTISTRY - POWERED POLYMERIZATION ACTIVATORS - PART 1: QUARTZ TUNGSTEN HALOGEN LAMPS |
| IEC 60118-13:2016 | Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC) |
| PREN 45502-1 : DRAFT 2013 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| BS 5724-2.39(1999) : 1999 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR PERITONEAL DIALYSIS EQUIPMENT |
| BS EN 62083:2009 | Medical electrical equipment. Requirements for the safety of radiotherapy treatment planning systems |
| I.S. EN ISO 8835-5:2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHESIA VENTILATORS |
| BS EN 60601-2-24:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
| I.S. EN ISO 10651-2:2009 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| BS ISO 27427:2013 | Anaesthetic and respiratory equipment. Nebulizing systems and components |
| 03/114562 DC : DRAFT SEP 2003 | BS EN ISO 18777 - TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
| CSA C22.2 No. 60601-2-31 : 2009 : INC : AMD 1 : 2014 : | MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| 14/30273278 DC : 0 | BS EN ISO 18397 - DENTISTRY - POWERED SCALER |
| ANSI/AAMI/IEC 60601-2-25:2011(R2016) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-25: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHS |
| ISO/TS 10650:1999 | Dental equipment Powered polymerization activators |
| BS EN 60601-2-63:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
| BS EN 60601-2-44 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (IEC 60601-2-44:2009) |
| ANSI/AAMI/IEC 60601-2-2:2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH FREQUENCY SURGICAL EQUIPMENT AND HIGH FREQUENCY SURGICAL ACCESSORIES |
| CSA ISO 11196 : 0 | ANAESTHETIC GAS MONITORS |
| CSA Z10651.3 : 0 | LUNG VENTILATORS FOR MEDICAL USE - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS |
| CAN/CSA-C22.2 NO. 80601-2-70:17 | Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (Adopted ISO 80601-2-70:2015, first edition, 2015-01 , with Canadian deviations) |
| BS EN 60601-2-47:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
| 09/30155521 DC : 0 | BS EN 60601-1-11 ED.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| EN 60601-2-64:2015 | Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment |
| ISO 14708-2:2012 | Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers |
| BS EN 60580:2000 | Dose area product meters |
| 15/30319030 DC : 0 | BS EN 60601-2-46 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-46: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OPERATING TABLES |
| 16/30316718 DC : 0 | BS EN ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
| 12/30263969 DC : 0 | BS EN 55011 - GENERAL MAINTENANCE FOR CISPR 11 ED.5.1 |
| CSA C22.2 No. 60601-2-63 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT |
| 04/30081057 DC : DRAFT AUG 2004 | EN ISO 10535 - HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
| 07/30165025 DC : 0 | BS EN 60601-2-31 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| NF EN 80601-2-35 : 2010 AMD 1 2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| 14/30296597 DC : 0 | BS EN 60601-2-54/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
| AAMI IEC 60601-2-19 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS |
| BS EN 60601-2-27:2014 | Medical electrical equipment Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
| I.S. EN 60601-2-21:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS |
| EN ISO 11073-10427:2018 | Health informatics - Personal health device communication - Part 10427: Device specialization - Power status monitor of personal health devices(ISO/IEEE 11073-10427:2018) |
| CSA Z18779 : 2008 | MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS |
| CSA Z17510.1 : 2010 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| BS IEC 60825-8:1999 | Safety of laser products Guidelines for the safe use of medical laser equipment |
| CSA Z18777 : 2008 : R2013 | TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
| AAMI ISO 14708-4:2008(R2011) | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS |
| CSA C22.2 No. 60601.2.27 : 2011 : INC : COR 1 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT |
| DIN EN ISO 80601-2-69:2014-12 | Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
| NF EN 60601 2-45 : 2011 AMD 1 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES |
| CSA Z10651.2 : 2006 : R2015 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| I.S. EN 60601-1-11:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| I.S. EN ISO 11073-30400:2012 | HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30400: INTERFACE PROFILE - CABLED ETHERNET (ISO 11073-30400:2012) |
| CSA C22.2 No. 80601-2-55 : 2014(R2019) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| IEEE/ANSI C63.27-2017 | American National Standard for Evaluation of Wireless Coexistence |
| AAMI HE75 : 2009(R2013) | HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
| NF EN 60601 2-18 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-18: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ENDOSCOPIC EQUIPMENT |
| I.S. EN 60601-2-30:2000 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT |
| BIS IS/ISO 14708-1 : 2000 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| EN 60601-1-11:2015 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| CEI EN 60601-2-26 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS |
| CISPR 11:2015 RLV | Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
| I.S. EN ISO 80601-2-55:2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS (ISO 80601-2-55:2018) |
| IEEE 11073-10418-2011 | IEEE Standard - Health informatics--Personal health device communication Part 10418: Device specialization--International Normalized Ratio (INR) monitor |
| CSA C22.2 No. 601.2.19 : 1992 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF BABY INCUBATORS |
| CEI EN 60601-2-65 : 2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT |
| I.S. EN 60645-5:2005 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 5: INSTRUMENTS FOR THE MEASUREMENT OF AURAL ACOUSTIC IMPEDANCE/ADMITTANCE |
| I.S. EN 45502-2-3:2010 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
| I.S. EN ISO 80601-2-69:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT (ISO 80601-2-69:2014) |
| ISO 18190:2016 | Anaesthetic and respiratory equipment — General requirements for airways and related equipment |
| BS EN 50174-3 : 2013 | INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 3: INSTALLATION PLANNING AND PRACTICES OUTSIDE BUILDINGS |
| UNE-EN ISO 10650:2016 | Dentistry - Powered polymerization activators (ISO 10650:2015) |
| I.S. EN 61669:2016 | ELECTROACOUSTICS - MEASUREMENT OF REAL-EAR ACOUSTICAL PERFORMANCE CHARACTERISTICS OF HEARING AIDS |
| ISO 14708-5:2010 | Implants for surgery Active implantable medical devices Part 5: Circulatory support devices |
| I.S. EN 60601-2-38:1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS |
| CSA C22.2 No. 80601-2-61 : 2014(R2019) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
| ASTM F 1452 : 2001 | Standard Specification for Minimum Performance and Safety Requirements for Anesthetic Gas Monitors |
| NF EN 55011 : 2016 AMD 1 2017 | INDUSTRIAL, SCIENTIFIC AND MEDICAL EQUIPMENT - RADIO-FREQUENCY DISTURBANCE CHARACTERISTICS - LIMITS AND METHODS OF MEASUREMENT |
| UNE-EN 1865-2:2011 | Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher |
| CSA C22.2 No. 60601.2.23 : 2012 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-23: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT |
| CAN/CSA-C22.2 No. 60601-2-65 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT |
| EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
| DIN EN 13976-2:2016-03 (Draft) | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| EN ISO 80601-2-56:2017 | Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017) |
| IEC 60601-2-5:2009 | Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
| I.S. EN 80601-2-58:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
| I.S. EN 60601-2-9:1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS |
| IEC 60601-2-34:2011 | Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
| ISO 27427:2013 | Anaesthetic and respiratory equipment — Nebulizing systems and components |
| I.S. EN 60601-2-23:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-23: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT |
| I.S. EN 62464-1:2007 | MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - PART 1: DETERMINATION OF ESSENTIAL IMAGE QUALITY PARAMETERS |
| UNE-EN 60601-2-21:2010 | Medical electrical equipment -- Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers |
| EN 60601-2-19:2009/A1:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS (IEC 60601-2-19:2009/A1:2016) |
| EN 60601-2-33:2010/A12:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS |
| EN 60601-2-21:2009/A1:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS (IEC 60601-2-21:2009/A1:2016) |
| EN 60601-2-20:2009/A1:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS (IEC 60601-2-20:2009/A1:2016) |
| DIN EN ISO 10535:2007-04 | Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006) |
| DIN EN ISO 11252:2014-02 | LASERS AND LASER-RELATED EQUIPMENT - LASER DEVICE - MINIMUM REQUIREMENTS FOR DOCUMENTATION (ISO 11252:2013) |
| ISO 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
| IEC 60601-2-4:2010+AMD1:2018 CSV | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| IEC 60601-2-49:2011 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| IEC 60601-2-19:2009+AMD1:2016 CSV | Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators |
| IEC 60601-2-25:2011 | Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
| BS EN ISO 11608-1:2015 | Needle-based injection systems for medical use. Requirements and test methods Needle-based injection systems |
| ISO 17510-1:2007 | Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment |
| BS EN ISO 21647:2009 | Medical electrical equipment. Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| BS EN ISO 18779:2005 | Medical devices for conserving oxygen and oxygen mixtures. Particular requirements |
| IEC 60601-2-18:2009 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| IEC 60601-2-26:2012 | Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
| BS EN ISO 8835-5:2009 | Inhalational anaesthesia systems Anaesthesia ventilators |
| BS EN ISO 18777:2009 | Transportable liquid oxygen systems for medical use. Particular requirements |
| BS EN ISO 8835-4:2009 | Inhalational anaesthesia systems Anaesthetic vapour delivery devices |
| PD IEC/TR 62354:2014 | General testing procedures for medical electrical equipment |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| DIN EN ISO 18779:2005-06 | Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005) |
| AAMI SP10 : 2002 | MANUAL, ELECTRONIC, OR AUTOMATED SPHYGMOMANOMETERS |
| EN 62274:2005 | Medical electrical equipment - Safety of radiotherapy record and verify systems |
| EN 60601-2-45:2011/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES (IEC 60601-2-45:2011/A1:2015) |
| EN ISO 11196 : 1997 | ANAESTHETIC GAS MONITORS |
| EN 62464-1:2007 | Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters |
| EN 60601-2-23:2015 | Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment |
| EN 12470-5:2003 | Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device) |
| EN 60601-2-38:1996/A1:2000 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS |
| EN ISO 11252:2013 | Lasers and laser-related equipment - Laser device - Minimum requirements for documentation (ISO 11252:2013) |
| CEN/TS 14507-2:2003 | Inhalational nitric oxide systems - Part 2: Supply systems |
| EN 60601-2-24:2015 | Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
| DIN EN ISO 8185:2009-07 | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| EN 60601-2-30:2000 | Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
| EN 62083:2009 | MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS |
| EN 80601-2-30:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS (IEC 80601-2-30:2009/A1:2013) |
| DIN EN 13976-2:2011-08 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| EN 50637:2017 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of medical beds for children |
| EN 60601-2-5:2015 | Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
| EN ISO 10535:2006 | Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006) |
| NF EN 60580 : 2004 | MEDICAL ELECTRICAL EQUIPMENT - DOSE AREA PRODUCT METERS |
| EN 60601-2-13 : 2006 AMD 1 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS |
| EN 60601-2-18:2015 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| EN 60601-2-46:2011 | Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables |
| EN 60731:2012 | Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy |
| EN 60601-2-12:2006 | Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators |
| EN 60601-2-62:2015 | Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment |
| EN 60601-2-36:2015 | Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy |
| EN 60601-2-27:2014 | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
| EN 60645-1:2017 | Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry |
| EN 60601-2-49:2015 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| EN 60645-6:2010 | Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions |
| CSA C22.2 No. 60601.2.26 : 2014(R2018) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIS SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS |
| CSA C22.2 No. 60601-2-21 : 2010FR | MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS |
| CSA C22.2 No. 60601.2.46 : 2012 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-46: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OPERATING TABLES |
| CSA C22.2 No. 60601-2-21 : 2010 : INC : COR 1 : 2017 : R201400 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS |
| CSA C22.2 No. 60601.2.4 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| CAN/CSA C22.2 No. 60601.2.43 : 2011(R2016) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
| UNE-EN 1865-3:2012 | Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher |
| CSA C22.2 No. 60601.2.50 : 2010 : R2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT |
| CSA C22.2 No. 60601-2-21 : 2010 : R2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS |
| CSA C22.2 No. 60601.1.2 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| CSA C22.2 No. 60601.2.46 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-46: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OPERATING TABLES |
| CSA C22.2 No. 60601.2.43 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
| CSA C22.2 No. 60601.2.16 : 2014(R2019) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT |
| CSA C22.2 No. 60601.2.50 : 2010FR | MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT |
| CSA C22.2 No. 60601.2.50 : 2010 : INC : COR 1 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT |
| CSA C22.2 No. 60601.2.2:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH FREQUENCY SURGICAL EQUIPMENT AND HIGH FREQUENCY SURGICAL ACCESSORIES |
| CSA C22.2 No. 60601.2.2 : 2009(R2014) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH FREQUENCY SURGICAL EQUIPMENT AND HIGH FREQUENCY SURGICAL ACCESSORIES |
| CSA C22.2 No. 60601-2-21 : 2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS |
| CSA C22.2 No. 60601.2.4 : 2012 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| UNE-EN 13544-1:2007 | Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
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