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BS EN 62366-1:2015

Действует
Medical devices. Application of usability engineering to medical devices — 54 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO/TR 16142:2006
Заменен
Medical devices -- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices — 24 стр.
ISO/IEC Guide 63:2012
Действует
Guide to the development and inclusion of safety aspects in International Standards for medical devices — 28 стр.
IEC TR 61258:2008 ed2.0
Действует
Guidelines for the development and use of medical electrical equipment educational materials — 16 стр.
BS EN ISO 13485:2012
Заменен
Medical devices. Quality management systems. Requirements for regulatory purposes — 86 стр.
ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.
BS EN ISO 9241-11:1998
Заменен
Ergonomic requirements for office work with visual display terminals (VDTs). Guidance on usability — 30 стр.
ISO 9241-11:1998
Заменен
Ergonomic requirements for office work with visual display terminals (VDTs) - Part 11: Guidance on usability — 28 стр.
BS EN ISO 9001:2008
Заменен
Quality management systems. Requirements — 40 стр.
ISO 9001:2008
Заменен
Quality management systems -- Requirements — 36 стр.
BS EN ISO 9000:2005
Заменен
Quality management systems. Fundamentals and vocabulary — 42 стр.
ISO 9000:2005
Заменен
Quality management systems -- Fundamentals and vocabulary — 38 стр.
BS EN ISO 7010:2012
Заменен
Graphical symbols. Safety colours and safety signs. Registered safety signs — 152 стр.
ISO 7010:2011
Действует
Graphical symbols -- Safety colours and safety signs -- Registered safety signs — 132 стр.
BS EN 60601-1-11:2015
Действует
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 — 68 стр.
IEC 60601-1-11:2010/COR1:2011 ed1.0
Заменен
Corrigendum 1 - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment — 0 стр.
BS EN 60601-1-8:2007
Заменен
Medical electrical equipment. 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 — 82 стр.
IEC 60601-1-8:2006 ed2.0
Действует
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 — 157 стр.
BS EN 60601-1-6:2010
Действует
Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Usability — 26 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 60601-1:2006
Заменен
Medical electrical equipment. General requirements for basic safety and essential performance — 384 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.
BS EN ISO 14971:2012
Действует
Medical devices. Application of risk management to medical devices — 104 стр.
ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
BS EN 1041:2008+A1:2013
Действует
Information supplied by the manufacturer of medical devices — 28 стр.
BS EN 1041:2008
Действует
Information supplied by the manufacturer of medical devices — 28 стр.
BS EN 62366:2008+A1:2015
Заменен
Medical devices. Application of usability engineering to medical devices — 108 стр.

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BS EN 80369-5:2016
Действует
Small-bore connectors for liquids and gases in healthcare applications. Connectors for limb cuff inflation applications — 46 стр.
17/30358661 DC
Действует
BS EN 13795-2. Surgical clothing and drapes. Requirements and test methods. Part 2. Clean air suits — 31 стр.
17/30358658 DC
Действует
BS EN 13795-1. Surgical clothing and drapes. Requirements and test methods. Part 1. Surgical drapes and gowns — 32 стр.
BS EN 62366:2008+A1:2015
Заменен
Medical devices. Application of usability engineering to medical devices — 108 стр.
BS EN 62304:2006+A1:2015
Действует
Medical device software. Software life-cycle processes — 88 стр.