IEC 60601-1-4:1996+AMD1:1999 CSV
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
Amended by
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
31-12-2021
Language(s)
English - French
Published date
07-04-2000
Publisher
Important note : Users cannot be edited or removed once added to your Multi user PDF.
FOREWORD
INTRODUCTION
SECTION 1: GENERAL
1 Scope, object and relationship to other standards
1.201 Scope
1.202 Object
1.203 Relationship to other standards
2 Terminology and definitions
2.201 Defined terms
2.202 Degrees of requirements and miscellaneous terms
6 Identification, marking and documents
6.8 ACCOMPANYING DOCUMENTS
SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL
TESTS
52 Abnormal operation and fault conditions
52.201 Documentation
52.202 RISK management plan
52.203 DEVELOPMENT LIFE-CYCLE
52.204 RISK management process
52.205 Qualification of personnel
52.206 Requirement specification
52.207 Architecture
52.208 Design and implementation
52.209 VERIFICATION
52.210 VALIDATION
52.211 Modification
52.212 Assessment
Annexes
AAA - Terminology - Index of defined terms
BBB - Rationale
CCC - RISK concepts
DDD - DEVELOPMENT LIFE-CYCLE
EEE - Examples for PEMS/PESS structures
FFF - Bibliography
Specifies requirements for the process by which a programmable electrical medical system is designed. Serves as the basis of requirements of Particular Standards, including serving as a guide to safety requirements for the purpose of reducing and managing risk. This standard covers requirement specification, architecture, detailed design and implementation software development, modification, verification and validation, marking and accompanying documents. This consolidated version consists of the first edition (1996) and its amendment 1 (1999). Therefore, no need to order amendment in addition to this publication.
| DevelopmentNote |
Also Numbered as BS EN 60601-1.4 & IEC 60601-1-4. (03/2001) Stability Date: 2013. (10/2012)
|
| DocumentType |
Standard
|
| Pages |
65
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Withdrawn
|
| Standards | Relationship |
| NF EN 60601-1-4 : 1999 AMD 1 2005 | Identical |
| NEN EN IEC 60601-1-4 : 1996 AMD 1 2000 | Identical |
| NEN 10601-1-4 : 1996 | Identical |
| I.S. EN 60601-1-4:1998 | Identical |
| PN EN 60601-1-4 : 2006 | Identical |
| SN EN 60601-1-4 : 1996 AMD 1 1999 | Identical |
| AS/NZS 3200.1.4:1997 | Identical |
| VDE 0750-1-4 : 2001 | Identical |
| UNE-EN 60601-1-4:1997 | Identical |
| EN 60601-1-4:1996/A1:1999 | Identical |
| CSA C22.2 No. 60601.1.4 : 2002 | Identical |
| DIN EN 60601-1-4 : 2001-04 | Identical |
| CSA C22.2 No. 60601-2-66 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS |
| BS EN 60601-2-51:2003 | Medical electrical equipment. Particular requirements for safety Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs |
| 04/30089749 DC : DRAFT DEC 2004 | BS EN 62304 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
| ISO/TR 27809:2007 | Health informatics Measures for ensuring patient safety of health software |
| I.S. EN ISO 22523:2006 | EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
| 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 |
| 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 |
| CSA Z10651.6 : 2006 : R2015 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| AAMI DF80 : 2003 : R2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS [INCLUDING AUTOMATED EXTERNAL DEFIBRILLATORS] |
| AAMI ISO TIR 16142 : 2005 | MEDICAL DEVICES - GUIDANCE ON THE SELECTION OF STANDARDS IN SUPPORT OF RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES |
| CSA ISO 14971 : 2007 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| CSA Z9919 : 2007 : R2012 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| 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. 60601.1.1 : 2002 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
| IEC TR 62348:2012 | Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition |
| I.S. EN 60601-2-66:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART-2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS |
| CSA C22.2 No. 60601.1.1 : 2002 : R2006 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
| CSA C22.2 No. 60601.2.51 : 2004 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS |
| 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) |
| AAMI ES60601-1 : 2005 : R2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| BS EN ISO 80601-2-13:2012+A2:2019 | Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| ISO 8835-5:2004 | Inhalational anaesthesia systems Part 5: Anaesthetic ventilators |
| ISO/IEEE 11073-00103:2015 | Health informatics — Personal health device communication — Part 00103: Overview |
| BS EN ISO 22523:2006 | External limb prostheses and external orthoses. Requirements and test methods |
| EN 62304:2006/A1:2015 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
| 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 ISO 22523:2006 | External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) |
| EN 60601-2-51:2003 | Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs |
| EN 60645-5:2005 | Electroacoustics - Audiometric equipment - Part 5: Instruments for the measurement of aural acoustic impedance/admittance |
| CEN/TS 15260:2006 | Health informatics - Classification of safety risks from health informatics products |
| 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 |
| BS EN ISO 80601-2-13:2012 | Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| 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 60645-6:2010 | Electroacoustics. Audiometric equipment Instruments for the measurement of otoacoustic emissions |
| DD ISO/TS 25238:2007 | Health informatics. Classification of safety risks from health software |
| 14/30315340 DC : 0 | BS EN 60601-2-66 ED.2 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS |
| 14/30287753 DC : 0 | BS EN 62304 AMENDMENT 1 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES |
| BS ISO 15378 : 2006 AMD 17315 | PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
| BS EN 60601-2-12:2006 | Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators |
| UNE-EN 60601-2-66:2016 | Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
| 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 |
| 07/30173580 DC : 0 | BS EN 60645-6 - ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS |
| ANSI Z80.11:2012 | OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING |
| AAMI TIR32 : 2004 : R2016 | MEDICAL DEVICE SOFTWARE RISK MANAGEMENT |
| BS EN 60601-2-66:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
| BS 5724-2.38(1997) : 1997 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS |
| CEI EN 60645-1 : 2016 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: EQUIPMENT FOR PURE-TONE AUDIOMETRY |
| CEI EN 62274 : 2005 | MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS |
| PD 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 |
| ISO 14708-2:2012 | Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers |
| CSA ISO/IEC TR 15942:2004 | INFORMATION TECHNOLOGY - PROGRAMMING LANGUAGES - GUIDE FOR THE USE OF THE ADA PROGRAMMING LANGUAGE IN HIGH INTEGRITY SYSTEMS |
| UNI EN ISO 7494-1 : 2011 | DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
| I.S. EN 60645-6:2010 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS |
| 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 |
| ISO 7494-1:2011 | Dentistry Dental units Part 1: General requirements and test methods |
| 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. 601.1.1 : 2000 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY - 1: COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
| CSA C22.2 No. 601.2.29 : 0 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY SIMULATORS |
| AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| I.S. EN ISO 14971:2012 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01) |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| AAMI ES60601-1 : 2005 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| DIN EN ISO 6875:2011-10 | DENTISTRY - PATIENT CHAIR |
| DIN EN 1640:2010-02 | Dentistry - Medical devices for dentistry - Equipment |
| 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 14971:2013-04 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
| 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 1640:2009 | Dentistry. Medical devices for dentistry. Equipment |
| BS EN 1441:1998 | Medical devices. Risk analysis |
| 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 |
| I.S. EN ISO 6875:2011 | DENTISTRY - PATIENT CHAIR |
| I.S. EN ISO 17510-1:2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| EN ISO 17510-1:2009 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
| I.S. EN 1640:2009 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
| I.S. 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 |
| 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 ISO 9919:2009 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| ANSI/AAMI/IEC TIR62348:2012 | ASSESSMENT OF THE IMPACT OF THE MOST SIGNIFICANT CHANGES IN AMENDMENT 1 TO IEC 60601-1:2005 AND MAPPING OF THE CLAUSES OF IEC 60601-1:2005 TO THE PREVIOUS EDITION |
| AAMI TIR72 : 2017 | DIALYSIS FLUID CHEMICAL COMPOSITION |
| 11/30243761 DC : 0 | BS ISO 14708-7 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS |
| BS ISO/IEC TR 15942:2000 | Information technology. Programming languages. Guide for the use of the Ada programming language in high integrity systems |
| UNE-EN 62304:2007 | Medical device software - Software life-cycle processes (IEC 62304:2006) |
| CSA ISO/IEC TR 15942 : 2004 : R2014 | INFORMATION TECHNOLOGY - PROGRAMMING LANGUAGES - GUIDE FOR THE USE OF THE ADA PROGRAMMING LANGUAGE IN HIGH INTEGRITY SYSTEMS |
| 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 |
| 07/30136476 DC : DRAFT APR 2007 | IEC 60601-2-44 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY |
| BS EN 60601-1-1:2001 | Medical electrical equipment. General requirements for safety Collateral standard. Safety requirements for medical electrical systems |
| 07/30173584 DC : 0 | BS EN 60645-7 - ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 7: INSTRUMENTS FOR THE MEASUREMENT OF AUDITORY EVOKED POTENTIALS |
| AAMI DF80:2003 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS [INCLUDING AUTOMATED EXTERNAL DEFIBRILLATORS] |
| AAMI ID26 : 2004 : R2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS |
| CSA Z10651.6 : 2006 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| CSA Z9919 :2007 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| AAMI IEC 62304 : 2006 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES |
| CEI EN 60601-2-12 : 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| UNE-EN ISO 7494-1:2012 | Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011) |
| I.S. EN 60601-1-1:2001 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
| 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 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) |
| CSA C22.2 No. 601.2.19 : 1992 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF BABY INCUBATORS |
| CSA C22.2 No. 601.2.13 : 0 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF ANAESTHETIC MACHINES |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| BS EN ISO 14971:2012 | Medical devices. Application of risk management to medical devices |
| I.S. EN 60645-5:2005 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 5: INSTRUMENTS FOR THE MEASUREMENT OF AURAL ACOUSTIC IMPEDANCE/ADMITTANCE |
| I.S. EN 62304:2006 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
| DIN EN ISO 22523:2007-04 | External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) |
| 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 |
| BS EN ISO 9919:2009 | Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
| IEC 60645-6:2009 | Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions |
| 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 |
| IEC 60601-2-66:2015 | Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
| IEC 60645-5:2004 | Electroacoustics - Audiometric equipment - Part 5: Instruments for the measurement of aural acoustic impedance/admittance |
| UNE-EN 60601-1:2008 | Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance |
| UNI EN ISO 6875 : 2011 | DENTISTRY - PATIENT CHAIR |
| UNI EN 1640 : 2010 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
| 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 |
| 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 ISO 10651-6 : 2009 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| I.S. EN ISO 11073-00103:2017 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015) |
| BS ISO/IEEE 11073-00103 : 2015 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW |
| PD ISO/TR 27809:2007 | Health informatics. Measures for ensuring patient safety of health software |
| I.S. EN 62274:2005 | MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS |
| EN 60601-1-1:2001 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| ISO/TS 25238:2007 | Health informatics Classification of safety risks from health software |
| CEI UNI EN ISO 14971 : 2013 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| 08/30176438 DC : DRAFT JAN 2008 | BS EN 60645-1 - ELECTRO ACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: PURE-TONE AUDIOMETERS |
| PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
| BS 5724-2.44(1999) : 1999 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY |
| BS EN 62274:2005 | Medical electrical equipment. Safety of radiotherapy record and verify systems |
| CSA C22.2 No. 60601.1.1 : 2002 : R2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
| BS EN ISO 11073-00103:2017 | Health informatics. Personal health device communication Overview |
| 12/30244415 DC : DRAFT APR 2012 | BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| NF EN 60645-6 : 2010 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS |
| CSA ISO 27427 : 2014 | 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 |
| BS EN 60645-5:2005 | Electroacoustics. Audiometric equipment Instruments for the measurement of aural acoustic impedance/admittance |
| 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 |
| UNI CEI EN ISO 14971 : 2012 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| 07/30145258 DC : 0 | BS ISO 20072 - AEROSOL DRUG DELIVERY DEVICES DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS |
| 01/561640 DC : DRAFT APR 2001 | BS EN ISO 8835-4 - INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
| DD CEN/TS 15260:2006 | Health informatics. Classification of safety risks from health informatics products |
| 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 |
| 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 |
| ANSI Z80.11 : 2012 : R2017 | OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING |
| AAMI TIR32 :2004 | MEDICAL DEVICE SOFTWARE RISK MANAGEMENT |
| EN ISO 7494-1:2011 | Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011) |
| CEI EN 60601-1-1 : 2003 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
| I.S. CEN TS 15260:2006 | HEALTH INFORMATICS - CLASSIFICATION OF SAFETY RISKS FROM HEALTH INFORMATICS PRODUCTS |
| AAMI ISO 14971 : 2007 : R2010 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| CSA Z8835.5 : 2006 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHETIC VENTILATORS |
| IEEE 730-2014 | IEEE Standard for Software Quality Assurance Processes |
| I.S. EN ISO 7494-1:2011 | DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
| CSA CEI/IEC 62304:14 (R2019) | Medical device software - Software life cycle processes (Adopted CEI/IEC 62304:2006, first edition, 2006-05) | Logiciels de dispositifs médicaux - Processus du cycle de vie du logiciel (norme CEI/IEC 62304:2006 adoptée, première édition, 2006-05) |
| UNI EN ISO 17510-1 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| BS EN ISO 7494-1:2011 | Dentistry. Dental units General requirements and test methods |
| 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 60601-2-38:1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS |
| DIN EN ISO 8835-5:2009-07 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHESIA VENTILATORS |
| UNE-EN ISO 6875:2012 | Dentistry - Patient chair (ISO 6875:2011) |
| 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 |
| IEC 62274:2005 | Medical electrical equipment - Safety of radiotherapy record and verify systems |
| 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 |
| BS EN ISO 11608-4:2007 | Pen-injectors for medical use Requirements and test methods for electronic and electromechanical pen-injectors |
| ISO 11608-4:2006 | Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors |
| IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| ISO 6875:2011 | Dentistry Patient chair |
| 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 |
| BS EN ISO 6875:2011 | Dentistry. Patient chair |
| ISO 22523:2006 | External limb prostheses and external orthoses — Requirements and test methods |
| 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 |
| 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 |
| EN ISO 11073-00103:2017 | Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015) |
| 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 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 1640:2009 | Dentistry - Medical devices for dentistry - Equipment |
| EN 1441 : 1997 | MEDICAL DEVICES - RISK ANALYSIS |
| 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 6875:2011 | Dentistry - Patient chair (ISO 6875:2011) |
| BS 5724-2.39(1999) : 1999 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR PERITONEAL DIALYSIS EQUIPMENT |
| I.S. EN ISO 8835-5:2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHESIA VENTILATORS |
| 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 |
| 14/30287226 DC : 0 | BS EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
| 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 |
| 00/560888 DC : APR 2000 | IEC 60601-1-2 EDITION 2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS |
| AAMI RD5 : 2003 | HEMODIALYSIS SYSTEMS |
| 04/30079743 DC : DRAFT APR 2004 | ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000 WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
| 03/111613 DC : DRAFT AUG 2003 | BS EN ISO 9919 - MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| AAMI ID26 : 2004 : R2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS |
| CSA Z17510.1 : 2010 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| 07/30166162 DC : 0 | BS IEC 60601-2-44 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY |
| CSA ISO 14971 : 2007 : R2017 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| CSA ISO 14971 : 2007 : R2012 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| 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 |
| CEI 62-143 : 2007 | MAPPING BETWEEN THE CLAUSES OF THE THIRD EDITION OF IEC 60601-1 AND THE 1988 EDITION AS AMENDED |
| BS EN 62304 : 2006 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
| CEI 65-186 : 2010 | GUIDELINE ON THE APPLICATION OF THE STANDARD SERIES CEI EN 61511 FUNCTIONAL SAFETY - SAFETY INSTRUMENTED SYSTEMS FOR THE PROCESS INDUSTRY SECTOR |
| CSA ISO/IEC TR 15942:04 (R2019) | Information Technology - Programming Languages - Guide for the Use of the Ada Programming Language in High Integrity Systems (Adopted ISO/IEC TR 15942:2000, first edition, 2000-03-01) |
| DIN EN ISO 7494-1:2011-11 | DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS (ISO 7494-1:2011) |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 27427:2013 | Anaesthetic and respiratory equipment — Nebulizing systems and components |
| I.S. EN 60601-2-51:2003 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| EN 60601-2-66:2015 | Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
| ISO 17510-1:2007 | Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment |
| BS EN ISO 8835-5:2009 | Inhalational anaesthesia systems Anaesthesia ventilators |
| IEC 60601-2-51:2003 | Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| EN 62274:2005 | Medical electrical equipment - Safety of radiotherapy record and verify systems |
| EN 60601-2-38:1996/A1:2000 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS |
| 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 60601-2-12:2006 | Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators |
| EN 60645-6:2010 | Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions |
| I.S. EN 60601- 1:2006&A1:2013&A12:2014&A2:2021 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005/A2:2020) |
| IEC 61025:2006 | Fault tree analysis (FTA) |
| ISO/IEC 15026:1998 | Information technology System and software integrity levels |
| IEC 60812:2006 | Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
| IEC 61508-5:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 5: Examples of methods for the determination of safety integrity levels (see Functional Safety and IEC 61508) |
| IEC 61508-4:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 4: Definitions and abbreviations (see Functional Safety and IEC 61508) |
| IEC 61508-3:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (see Functional Safety and IEC 61508) |
| IEC TR 60513:1994 | Fundamental aspects of safety standards for medical electrical equipment |
| ISO/IEC 12119:1994 | Information technology Software packages Quality requirements and testing |
| IEC 60880:2006 | Nuclear power plants - Instrumentation and control systems important to safety - Software aspects for computer-based systems performing category A functions |
| IEC 61508-6:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 6: Guidelines on the application of IEC 61508-2 and IEC 61508-3 (see Functional Safety and IEC 61508) |
| IEC 61508-1:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements (see Functional Safety and IEC 61508) |
| IEC 61508-7:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 7: Overview of techniques and measures (see Functional Safety and IEC 61508) |
| IEC 61508-2:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 2: Requirements for electrical/electronic/programmable electronic safety-related systems (see Functional Safety and IEC 61508) |
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