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BS EN 62304:2006

Заменен
Medical device software. Software life-cycle processes — 80 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
IEC 61508-3:1998/COR1:1999 ed1.0
Заменен
Corrigendum 1 - Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements — 1 стр.
BS EN 61010-1:2001
Заменен
Safety requirements for electrical equipment for measurement, control and laboratory use. General requirements — 120 стр.
IEC 60601-1:2005/COR1:2012+AMD1:2012 CSV ed3.1
Действует
Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance — 0 стр.
IEC 60601-1-4:1996 ed1.0
Отменен
Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems — 61 стр.
IEC 61010-1:2001/COR1:2002 ed2.0
Заменен
Corrigendum 1 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements — 0 стр.
ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.
BS ISO/IEC 9126-1:2001
Заменен
Information technology. Software product quality. Quality model — 34 стр.
IEC 60601-1-6:2010 ed3.0
Действует
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability — 51 стр.
BS EN 60601-1-6:2004
Заменен
Medical electrical equipment. General requirements for safety. Collateral standard. Usability — 78 стр.
ISO 9000:2005
Заменен
Quality management systems -- Fundamentals and vocabulary — 38 стр.
BS EN ISO 9000:2005
Заменен
Quality management systems. Fundamentals and vocabulary — 42 стр.
BS EN ISO 13485:2003
Заменен
Medical devices. Quality management systems. Requirements for regulatory purposes — 72 стр.
ISO/IEC 90003:2004
Заменен
Software engineering -- Guidelines for the application of ISO 9001:2000 to computer software — 62 стр.
BS EN 62304:2006+A1:2015
Действует
Medical device software. Software life-cycle processes — 88 стр.

На этот документ ссылаются

BS EN 60601-1:2006
Заменен
Medical electrical equipment. General requirements for basic safety and essential performance — 384 стр.
BS EN 60601-2-66:2013
Заменен
Medical electrical equipment. Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems — 48 стр.
DIN EN 14180:2014-09
Действует
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2014 — 69 стр.
DIN EN 1640:2010-02
Действует
Dentistry - Medical devices for dentistry - Equipment — 16 стр.
DIN EN 794-3:2009-12
Действует
Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators; German version EN 794-3:1998+A2:2009 — 44 стр.
DIN EN 1422:2014-08
Действует
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods; German version EN 1422:2014 — 47 стр.
DIN EN 12182:2012-07
Действует
Assistive products for persons with disability - General requirements and test methods; German version EN 12182:2012 — 66 стр.
DIN EN 12184:2014-06
Действует
Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods; German version EN 12184:2014 — 64 стр.
BS ISO/IEEE 11073-10441:2015
Действует
Health informatics. Personal health device communication. Device specialization. Cardiovascular fitness and activity monitor — 118 стр.
BS EN 45502-1:2015
Действует
Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer — 64 стр.
BS EN ISO 11073-20601:2016
Действует
Health informatics. Personal health device communication. Application profile. Optimized exchange protocol — 254 стр.
BS EN ISO 11073-10441:2017
Действует
Health informatics. Personal health device communication. Device specialization. Cardiovascular fitness and activity monitor — 118 стр.
BS EN ISO 11073-10418:2014
Действует
Health informatics. Personal health device communication. Device specialization. International Normalized Ratio (INR) monitor — 78 стр.
BS EN ISO 11073-00103:2017
Действует
Health informatics. Personal health device communication. Overview — 88 стр.
PAS 277:2015
Действует
Health and wellness apps. Quality criteria across the life cycle. Code of practice — 36 стр.
BS EN 14180:2014
Действует
Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing — 66 стр.
BS EN 12184:2014
Действует
Electrically powered wheelchairs, scooters and their chargers. Requirements and test methods — 64 стр.
BS EN 12182:2012
Действует
Assistive products for persons with disability. General requirements and test methods — 66 стр.
BS EN 794-3:1998+A2:2009
Действует
Lung ventilators. Particular requirements for emergency and transport ventilators — 48 стр.
BS EN 1640:2009
Действует
Dentistry. Medical devices for dentistry. Equipment — 16 стр.
BS EN 1422:2014
Действует
Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods — 54 стр.
17/30364306 DC
Действует
BS EN 17180. Sterilizers for medical purposes. Low temperature vaporized hydrogen peroxide sterilizers. Requirements and testing — 90 стр.
BS EN 60601-1:2006+A11:2011
Действует
Medical electrical equipment. General requirements for basic safety and essential performance — 386 стр.
BS EN 62083:2009
Действует
Medical electrical equipment. Requirements for the safety of radiotherapy treatment planning systems — 34 стр.
BS EN 60601-1-10:2008+A1:2015
Действует
Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Requirements for the development of physiologic closed-loop controllers — 44 стр.
BS EN 60601-1-10:2008
Действует
Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Requirements for the development of physiologic closed-loop controllers — 44 стр.
BS EN 62304:2006+A1:2015
Действует
Medical device software. Software life-cycle processes — 88 стр.
BS EN ISO 11073-10406:2012
Действует
Health informatics. Personal health device communication. Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG) — 74 стр.
BS EN 80001-1:2011
Действует
Application of risk management for IT-networks incorporating medical devices. Roles, responsibilities and activities — 44 стр.
ÖVE/ÖNORM EN 60601-2-66:2015-09
Заменен
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems (IEC 60601-2-66:2012) (english version)
ÖVE/ÖNORM EN 45502-1:2016-03
Действует
Implants for surgery - Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer (english version)
ÖVE/ÖNORM EN 60601-1:2014-02
Действует
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012) (english version)
ÖVE/ÖNORM EN 62083:2013-05
Действует
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems (IEC 62083:2009)
ÖNORM EN 794-3:2010-01
Действует
Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
ÖNORM EN 12182:2012-06
Действует
Assistive products for persons with disability - General requirements and test methods
ÖNORM EN 12184:2014-05
Действует
Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
ÖNORM EN 1640:2010-03
Действует
Dentistry - Medical devices for dentistry - Equipment