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EN 60601-1-2:2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
31-12-2018
18-09-2015
FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 ME EQUIPMENT and ME SYSTEMS identification,
marking and documents
6 Documentation of the tests
7 ELECTROMAGNETIC EMISSIONS requirements for
ME EQUIPMENT and ME SYSTEMS
8 Electromagnetic IMMUNITY requirements for ME
EQUIPMENT and ME SYSTEMS
9 Test report
Annex A (informative) - General guidance and rationale
Annex B (informative) - Guide to marking and labelling
requirements for ME EQUIPMENT and ME SYSTEMS
Annex C (informative) - Guidance in classification according
to CISPR 11
Annex D (informative) - Guidance in the application of
IEC 60601-1-2 to particular standards
Annex E (informative) - Determination of IMMUNITY TEST
LEVELS for SPECIAL ENVIRONMENTS
Annex F (informative) - RISK MANAGEMENT for BASIC
SAFETY and ESSENTIAL PERFORMANCE
with regard to ELECTROMAGNETIC DISTURBANCES
Annex G (informative) - Guidance: Test plan
Annex H (informative) - PATIENT-coupled cables
EMISSIONS
Annex I (informative) - Identification of IMMUNITY pass/fail
criteria
Bibliography
Index of defined terms used in this collateral standard
Annex ZA (normative) - Normative references to
international publications with their
corresponding European publications
Annex ZZ (informative) - Coverage of Essential
Requirements of EU Directives
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 |
CLC/TC 62
|
DocumentType |
Standard
|
PublisherName |
European Committee for Standards - Electrical
|
Status |
Withdrawn
|
SupersededBy | |
Supersedes |
Standards | Relationship |
VDE 0750-1-2:2007-12 | Identical |
SS-EN 60601-1-2 : 2015 | Identical |
VDE 0750-1-2 : 2016 | Identical |
IEC 60601-1-2:2014 | Identical |
SN EN 60601-1-2 : 2015 | Identical |
NEN EN IEC 60601-1-2 : 2015 | Identical |
NF EN 60601-1-2 : 2016 | Identical |
NBN EN 60601 1-2 : 2015 | Identical |
I.S. EN 60601-1-2:2015 | Identical |
CEI EN 60601-1-2 : 2016 | Identical |
CEI EN 60601-1-2:2018 | Identical |
PN EN 60601-1-2 : 2015 | Identical |
BS EN 60601-1-2:2015 | Identical |
ONORM OVE EN 60601-1-2 : 2016 | Identical |
DIN EN 60601-1-2:2016-05 | Identical |
DIN EN 60601-1-2:2007-12 | Identical |
UNE-EN 60601-1-2:2008 | Identical |
UNE-EN 60601-1-2:2015 | Identical |
BS 5724-1.2(1993) : 1993 AMD 10002 | Identical |
NEN 10601-1-2 : 1993 | Identical |
DIN EN 60601-1-2 : 2006-10 | Identical |
PNE-FprEN 60601-1-2 | Identical |
IEC 60601-1-2:2007 | Identical |
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 |
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 |
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 |
I.S. EN 740:1999 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
BS EN 60601-2-36:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy |
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 |
I.S. CEN/TS 14507-1:2003 | INHALATIONAL NITRIC OXIDE SYSTEMS - PART 1: DELIVERY SYSTEMS |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 1865-2 : 2010 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
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 Z10535 : 2003 | HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
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 |
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 |
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 |
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 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 |
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 45502-2-3 : 2010 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
I.S. EN 1865-2:2010 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
DIN EN 1060-3:2010-03 | NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS |
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 60601-2-25:2016 | Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
ISO/IEEE 11073-00103:2015 | Health informatics Personal health device communication Part 00103: Overview |
BS EN 794-2:1997 | Lung ventilators Particular requirements for home care use |
DIN EN 12470-3:2000-04 | CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE |
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 |
EN 1060-3:1997+A2:2009 | Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
EN 60601-2-47:2015 | Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
EN 60601-2-26:2015 | Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
EN 12182:2012 | Assistive products for persons with disability - General requirements and test methods |
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 |
EN 60645-5:2005 | Electroacoustics - Audiometric equipment - Part 5: Instruments for the measurement of aural acoustic impedance/admittance |
DIN EN 793 : 1998 | PARTICULAR REQUIREMENTS FOR SAFETY OF MEDICAL SUPPLY UNITS |
EN 12470-3:2000+A1:2009 | Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
EN 12598 : 1999 | OXYGEN MONITORS FOR PATIENT BREATHING MIXTURES - PARTICULAR REQUIREMENTS |
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 |
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 |
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 |
I.S. EN 12470-5:2003 | CLINICAL THERMOMETERS - PART 5: PERFORMANCE OF INFRA-RED EAR THERMOMETERS (WITH MAXIMUM DEVICE) |
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 |
CEI EN 60601-2-40 : 1999 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT |
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 |
CEI EN 60731 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY |
I.S. EN 1865-3:2012 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
BS EN 60645-6:2010 | Electroacoustics. Audiometric equipment Instruments for the measurement of otoacoustic emissions |
BS EN 60601-2-46:2011 | Medical electrical equipment Particular requirements for the basic safety and essential performance of operating tables |
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) |
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 |
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 |
BS 5724-2.40(1998) : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - PART 2-40: ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT |
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 |
CEI EN 62274 : 2005 | MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS |
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) |
03/111581 DC : DRAFT JULY 2003 | BS EN ISO 18778 - INFANT MONITORS - PARTICULAR REQUIREMENTS |
CSA Z10535 : 2003 : R2014 | HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
BS EN 60601-2-25:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of electrocardiographs |
BS EN 60601-2-40:1998 | Medical electrical equipment. Particular requirements for safety Specification for electromyographs and evoked response equipment |
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 |
BS EN 60601-2-23:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment |
I.S. EN 60601-2-26:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS |
UNE-EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
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 |
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 |
I.S. EN 50637:2017 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS FOR CHILDREN |
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) |
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 |
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 |
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 |
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 |
CEI EN 50174-3 : 2014 | INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 3: INSTALLATION PLANNING AND PRACTICES OUTSIDE BUILDINGS |
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 |
I.S. EN 60601-2-54:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
CEI EN 60601-2-46 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-46: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OPERATING TABLES |
PREN 12182 : 2009-06 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
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)) |
I.S. EN 62083:2009 | MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS |
DIN EN 12182:2012-07 | Assistive products for persons with disability - General requirements and test methods |
BS EN 12470-3 : 2000 | CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE |
CSA C22.2 No. 281.2 : 2012 : INC : UPD 1 : 2015 | STANDARD FOR SAFETY FOR PERSONNEL PROTECTION SYSTEMS FOR ELECTRIC VEHICLE (EV) SUPPLY CIRCUITS: PARTICULAR REQUIREMENTS FOR PROTECTION DEVICES FOR USE IN CHARGING SYSTEMS |
I.S. EN 1060-3:1997 | NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS |
DIN EN 12470-5:2003-09 | CLINICAL THERMOMETERS - PART 5: PERFORMANCE OF INFRA-RED EAR THERMOMETERS (WITH MAXIMUM DEVICE) |
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 |
DIN EN 794-1:2001-02 | LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS |
I.S. EN 794-3:1998 | LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS |
DIN EN 1970:2005-10 | ADJUSTABLE BEDS FOR DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
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 |
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 |
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 |
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 |
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 |
BS EN 1865-3 : 2012 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
BS EN 60601-2-34:2014 | Medical electrical equipment Particular requirements for the basic safety and essential performance of invasive blood pressure 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 |
DIN EN 1865-2:2015-05 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
BS EN 60601-2-18:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of endoscopic equipment |
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 |
BS EN 60645-1:2017 | Electroacoustics. Audiometric equipment Equipment for pure-tone and speech audiometry |
12/30260552 DC : 0 | BS EN 50174-3:201X - INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 3: INSTALLATION PLANNING AND PRACTICES OUTSIDE BUILDINGS |
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 |
09/30201992 DC : 0 | BS EN 12182 - ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
BS EN 60601-2-12:2006 | Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators |
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 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 |
UNE-EN 55011:2011 | Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
03/317861 DC : DRAFT OCT 2003 | EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
CEI EN 60601-2-25 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-25: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHS |
UNI EN 13976-2 : 2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
VDE 0750-2-40 : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT |
CEI EN 60601-2-12 : 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
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 |
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) |
BS EN 55011 : 2016 | INDUSTRIAL, SCIENTIFIC AND MEDICAL EQUIPMENT - RADIO-FREQUENCY DISTURBANCE CHARACTERISTICS - LIMITS AND METHODS OF MEASUREMENT |
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 |
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 |
I.S. EN 50174-3:2013 | INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 3: INSTALLATION PLANNING AND PRACTICES OUTSIDE BUILDINGS |
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 |
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) |
PREN 50174-3 : DRAFT 2012 | INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 3: INSTALLATION PLANNING AND PRACTICES OUTSIDE BUILDINGS |
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 |
DIN EN 12470-3:2009-11 | CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE |
DIN EN 12470-4:2009-11 | CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT |
DIN EN 13544-1:2009-12 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
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 12470-5:2003 | Clinical thermometers Performance of infra-red ear thermometers (with maximum device) |
CAN/CSA-C22.2 NO. 281.2-12 (R2017) | Standard for safety for personnel protection systems for electric vehicle (EV) supply circuits: Particular requirements for protection devices for use in charging systems (Tri-national standard, with UL 2231-2 and NMX-J-668/2-ANCE) |
CSA C22.2 No. 281.2 : 2012 : INC : UPD 2 : 2016 | STANDARD FOR SAFETY FOR PERSONNEL PROTECTION SYSTEMS FOR ELECTRIC VEHICLE (EV) SUPPLY CIRCUITS: PARTICULAR REQUIREMENTS FOR PROTECTION DEVICES FOR USE IN CHARGING SYSTEMS |
UL 2231-2:2ED 2012-09-07 | Personnel Protection Systems for Electric Vehicle (EV) Supply Circuits: Particular Requirements for Protection Devices for Use in Charging Systems |
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 |
CSA C22.2 No. 281.2:2012 | STANDARD FOR SAFETY FOR PERSONNEL PROTECTION SYSTEMS FOR ELECTRIC VEHICLE (EV) SUPPLY CIRCUITS: PARTICULAR REQUIREMENTS FOR PROTECTION DEVICES FOR USE IN CHARGING SYSTEMS |
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 1970:2000/A1:2005 | ADJUSTABLE BEDS FOR DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
UNI EN 12470-4 : 2009 | CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT |
UNI EN 12470-3 : 2009 | CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE |
UNI EN 1060-3 : 2010 | NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS |
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 794-1 : 2009 | LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS |
UNI EN 12182 : 2012 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
UNI EN 794-3 : 2009 | LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS |
I.S. EN ISO 11073-00103:2017 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015) |
DD CEN/TS 14507-1:2003 | Inhalational nitric oxide systems Delivery systems |
PREN 13976-2 : DRAFT 2016 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
CEI EN 60645-6 : 2013 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS |
I.S. EN 794-2:1997 | LUNG VENTILATORS - PARTICULAR REQUIREMENTS FOR HOME CARE USE |
BS ISO/IEEE 11073-00103 : 2015 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW |
I.S. EN 62274:2005 | MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY 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 |
05/30134824 DC : 0 | EN 50447 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR HEART-LUNG MACHINES (HLM) |
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 |
95/214875 DC : 0 | PREN 50222 - STANDARD FOR THE EVALUATION OF MEASUREMENT RESULTS TAKING MEASUREMENT UNCERTAINTY INTO ACCOUNT |
BS 5724-2.36(1997) : 1997 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR EQUIPMENT FOR EXTRA-CORPOREALLY INDUCED LITHOTRIPSY |
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 |
DD CEN/TS 14507-2:2003 | Inhalational nitric oxide systems Supply systems |
CEI EN 60601-2-4 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
BS EN 62274:2005 | Medical electrical equipment. Safety of radiotherapy record and verify systems |
BS EN ISO 11073-00103:2017 | Health informatics. Personal health device communication Overview |
BS 5724-2.18(1997) : 1997 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ENDOSCOPIC EQUIPMENT |
DIN EN 1865-3:2015-05 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
CEI EN 62083 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS |
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 |
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 |
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) |
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 |
EN 50174-3:2013/A1:2017 | INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 3: INSTALLATION PLANNING AND PRACTICES OUTSIDE BUILDINGS |
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) |
CEI EN 55011 : 2017 | INDUSTRIAL, SCIENTIFIC AND MEDICAL EQUIPMENT - RADIO-FREQUENCY DISTURBANCE CHARACTERISTICS - LIMITS AND METHODS OF MEASUREMENT |
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 |
I.S. EN 60601-2-40:1999 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT |
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 |
BS EN ISO 11197:2009 | Medical supply units |
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 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 60580:2000 | MEDICAL ELECTRICAL EQUIPMENT - DOSE AREA PRODUCT METERS |
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. CEN/TS 14507-2:2003 | INHALATIONAL NITRIC OXIDE SYSTEMS - PART 2: SUPPLY SYSTEMS |
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) |
UNE-EN 60645-1:2015 | Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone audiometry |
BS EN 60601-1 : 2006 | MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
BS EN 13976-2:2011 | Rescue systems. Transportation of incubators System requirements |
EN 60580:2000 | Medical electrical equipment - Dose area product meters |
BS EN 13544-1 : 2007 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
BS EN 864:1997 | Medical electrical equipment. Capnometers for use with humans. Particular requirements |
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 |
BS EN 12470-4 : 2001 | CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT |
BS EN 794-3 : 1999 | LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS |
BS EN 740:1999 | Anaesthetic workstations and their modules. Particular requirements |
UNE-EN 45502-2-3:2010 | Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
DIN EN 13976-2 E : 2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
BS EN 1970:2000 | Adjustable beds for disabled persons. Requirements and test methods |
UNE-EN 62083:2010 | Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
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) |
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 ISO 11073-00103:2017 | Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015) |
EN 1865-2:2010+A1:2015 | Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher |
EN 864 : 1996 | MEDICAL ELECTRICAL EQUIPMENT - CAPNOMETERS FOR USE WITH HUMANS - PARTICULAR REQUIREMENTS |
EN 794-2 : 1997 | LUNG VENTILATORS - PARTICULAR REQUIREMENTS FOR HOME CARE USE |
EN 45502-2-3:2010 | Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
EN 740:1998/A1:2004 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
EN 1865-3:2012+A1:2015 (edition 2) | Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher |
EN 12470-4:2000+A1:2009 | Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement |
EN 865 : 1997 | PULSE OXIMETERS - PARTICULAR REQUIREMENTS |
EN 794-3:1998+A2:2009 | Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators |
EN 794-1:1997+A2:2009 | Lung ventilators - Part 1: Particular requirements for critical care ventilators |
EN 793 : 1997 | PARTICULAR REQUIREMENTS FOR SAFETY OF MEDICAL SUPPLY UNITS |
BS EN 50637:2017 | Medical electrical equipment. Particular requirements for the basic safety and essential performance of medical beds for children |
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 |
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 |
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 EN 62083:2009 | Medical electrical equipment. Requirements for the safety of radiotherapy treatment planning systems |
BS EN 60601-2-24:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
16/30333925 DC : 0 | BS EN 13976-2 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
03/114562 DC : DRAFT SEP 2003 | BS EN ISO 18777 - TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
BS EN 60601-2-47:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
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 |
09/30192344 DC : 0 | BS EN 1060-3:1997/A2 - NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS |
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 |
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 EN 60580:2000 | Dose area product meters |
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 |
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 |
02/637047 DC : DRAFT APR 2002 | BS EN 50174-3 - INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 3: INSTALLATION PLANNING AND PRACTICES OUTSIDE BUILDINGS |
BS EN 60601-2-27:2014 | Medical electrical equipment Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
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 |
CEI EN 60645-5 : 2006 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 5: INSTRUMENTS FOR THE MEASUREMENT OF AURAL ACOUSTIC IMPEDANCE/ADMITTANCE |
IEEE 11073-00103-2012 | Health informatics - Personal health device communication Part 00103: Overview |
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 |
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 |
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 |
BS EN 50174-3 : 2013 | INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 3: INSTALLATION PLANNING AND PRACTICES OUTSIDE BUILDINGS |
I.S. EN 61669:2016 | ELECTROACOUSTICS - MEASUREMENT OF REAL-EAR ACOUSTICAL PERFORMANCE CHARACTERISTICS OF HEARING AIDS |
I.S. EN 60601-2-38:1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS |
UNE-EN 1865-2:2011 | Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher |
EN 13976-2:2011 | 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) |
DIN EN 13976-2:2016-03 (Draft) | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
I.S. EN 55011:2016 | INDUSTRIAL, SCIENTIFIC AND MEDICAL EQUIPMENT - RADIO-FREQUENCY DISTURBANCE CHARACTERISTICS - LIMITS AND METHODS OF MEASUREMENT |
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 |
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 |
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 794-3:2009-12 | Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators; German version EN 794-3:1998+A2:2009 |
BS EN 12598:1999 | Oxygen monitors for patient breathing mixtures. Particular requirements |
BS EN 1060-3 : 1997 | NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS |
BS EN 793:1998 | Particular requirements for safety of medical supply units |
BS EN 865:1997 | Pulse oximeters. Particular requirements |
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 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 |
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 |
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 |
DIN EN 13976-2:2011-08 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
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) |
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 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 60645-1:2017 | Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry |
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 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 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 |
UNE-EN 1865-3:2012 | Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher |
UNE-EN 794-3:1999 | LUNG VENTILATORS. PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS. |
UNE-EN 13544-1:2007 | Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
IEC 61000-4-8 : 2.0 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-8: TESTING AND MEASUREMENT TECHNIQUES - POWER FREQUENCY MAGNETIC FIELD IMMUNITY TEST |
CISPR 14-1:2016 | Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus - Part 1: Emission |
ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
IEC 60601-2-3:2012+AMD1:2016 CSV | Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment |
IEC 61000-3-11 : 2.0 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-11: LIMITS - LIMITATION OF VOLTAGE CHANGES, VOLTAGE FLUCTUATIONS AND FLICKER IN PUBLIC LOW-VOLTAGE SUPPLY SYSTEMS - EQUIPMENT WITH RATED CURRENT <= 75 A AND SUBJECT TO CONDITIONAL CONNECTION |
IEC TR 61000-1-1:1992 | Electromagnetic compatibility (EMC) - Part 1: General - Section 1: Application and interpretation of fundamental definitions and terms |
IEC 61000-4-4 : 3.0EN+(REDLINE+VERSION) | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST |
EN 61000-4-11:2004/A1:2017 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-11: TESTING AND MEASUREMENT TECHNIQUES - VOLTAGE DIPS, SHORT INTERRUPTIONS AND VOLTAGE VARIATIONS IMMUNITY TESTS (IEC 61000-4-11:2004/A1:2017) |
IEC 61000-6-2:2016 | Electromagnetic compatibility (EMC) - Part 6-2: Generic standards - Immunity standard for industrial environments |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
CISPR 16-1-1:2015 | Specification for radio disturbance and immunity measuring apparatus and methods - Part 1-1: Radio disturbance and immunity measuring apparatus - Measuring apparatus |
IEC 61000-4-11:2004+AMD1:2017 CSV | Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests |
EN 61000-3-3:2013 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-3: LIMITS - LIMITATION OF VOLTAGE CHANGES, VOLTAGE FLUCTUATIONS AND FLICKER IN PUBLIC LOW-VOLTAGE SUPPLY SYSTEMS, FOR EQUIPMENT WITH RATED CURRENT <= 16 A PER PHASE AND NOT SUBJECT TO CONDITIONAL CONNECTION (IEC 61000-3-3:2013) |
IEC TS 61000-1-2:2008 | Electromagnetic compatibility (EMC) - Part 1-2: General - Methodology for the achievement of functional safety of electrical and electronic systems including equipment with regard to electromagnetic phenomena |
IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
ISO 11451-3:2015 | Road vehicles — Vehicle test methods for electrical disturbances from narrowband radiated electromagnetic energy — Part 3: On-board transmitter simulation |
ISO 7637-2:2011 | Road vehicles Electrical disturbances from conduction and coupling Part 2: Electrical transient conduction along supply lines only |
IEC 61000-6-1 : 3.0 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 6-1: GENERIC STANDARDS - IMMUNITY STANDARD FOR RESIDENTIAL, COMMERCIAL AND LIGHT-INDUSTRIAL ENVIRONMENTS |
IEC 61000-4-8:2009 | Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test |
IEC 61000-3-12:2011 | Electromagnetic compatibility (EMC) - Part 3-12: Limits - Limits for harmonic currents produced by equipment connected to public low-voltage systems with input current >16 A and ≤ 75 A per phase |
IEC 61000-4-4:2012 RLV | Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test |
EN 61000-4-2:2009 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
CISPR 32:2015 RLV | Electromagnetic compatibility of multimedia equipment - Emission requirements |
IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
IEC 61000-4-6 : 4.0 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS |
IEC 61000-4-6:2013 | Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields |
EN 61000-4-3 : 2006 AMD 2 2010 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST |
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 |
CISPR 25:2016 | Vehicles, boats and internal combustion engines - Radio disturbance characteristics - Limits and methods of measurement for the protection of on-board receivers |
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 |
ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
IEEE/ANSI C63.14-2014 REDLINE | American National Standard Dictionary of Electromagnetic Compatibility (EMC) including Electromagnetic Environmental Effects (E3) |
ISO 14708-3:2017 | Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators |
MIL-STD-461 Revision G:2015 | REQUIREMENTS FOR THE CONTROL OF ELECTROMAGNETIC INTERFERENCE CHARACTERISTICS OF SUBSYSTEMS AND EQUIPMENT |
EN 61000-4-8:2010 | Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test |
IEC 61000-4-2:2008 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
IEC 60601-2-27:2011 | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
CISPR 16-2-3:2016 | Specification for radio disturbance and immunity measuring apparatus and methods - Part 2-3: Methods of measurement of disturbances and immunity - Radiated disturbance measurements |
IEC 61000-3-3:2013 RLV | Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤ 16 A per phase and not subject to conditional connection |
EN 61000-3-2:2014 | Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤ 16 A per phase) |
IEC 61000-6-1:2016 | Electromagnetic compatibility (EMC) - Part 6-1: Generic standards - Immunity standard for residential, commercial and light-industrial environments |
IEC 61496-1:2012 | Safety of machinery - Electro-sensitive protective equipment - Part 1: General requirements and tests |
ISO 11452-9:2012 | Road vehicles Component test methods for electrical disturbances from narrowband radiated electromagnetic energy Part 9: Portable transmitters |
EN 55103-2:2009 | Electromagnetic compatibility - Product family standard for audio, video, audio-visual and entertainment lighting control apparatus for professional use - Part 2: Immunity |
EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
ISO 11452-8:2015 | Road vehicles — Component test methods for electrical disturbances from narrowband radiated electromagnetic energy — Part 8: Immunity to magnetic fields |
ISO 7137:1995 | Aircraft — Environmental conditions and test procedures for airborne equipment |
IEC 61000-3-3 : 3.0EN+(REDLINE+VERSION) | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-3: LIMITS - LIMITATION OF VOLTAGE CHANGES, VOLTAGE FLUCTUATIONS AND FLICKER IN PUBLIC LOW-VOLTAGE SUPPLY SYSTEMS, FOR EQUIPMENT WITH RATED CURRENT <= 16 A PER PHASE AND NOT SUBJECT TO CONDITIONAL CONNECTION |
EN 61000-4-4:2012 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST (IEC 61000-4-4:2012) |
CISPR 11:2015 RLV | Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
ISO 14971:2007 | Medical devices Application of risk management to medical devices |
IEC 61000-6-2 : 3.0:2016 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 6-2: GENERIC STANDARDS - IMMUNITY STANDARD FOR INDUSTRIAL ENVIRONMENTS |
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 |
CISPR 24:2010+AMD1:2015 CSV | Information technology equipment - Immunity characteristics - Limitsand methods of measurement |
IEC 61000-4-13:2002+AMD1:2009+AMD2:2015 CSV | Electromagnetic compatibility (EMC) - Part 4-13: Testing and measurement techniques - Harmonics and interharmonics includingmains signalling at a.c. power port, low frequency immunity tests |
EN 55014-1:2017 | Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus - Part 1: Emission |
EN 60601-1-8:2007/A11:2017 | 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 (IEC 60601-1-8:2006/A1:2012) |
IEC 61000-3-2 : 4.0 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-2: LIMITS - LIMITS FOR HARMONIC CURRENT EMISSIONS (EQUIPMENT INPUT CURRENT <= 16 A PER PHASE) |
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 |
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