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18/30382933 DC

Действует
BS ISO/IEC Guide 63. Guide to the development and inclusion of aspects of safety in international standards for medical devices — 34 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO/IEC Guide 14:2003
Заменен
Purchase information on goods and services intended for consumers — 20 стр.
IEC 82079-1:2012 ed1.0
Заменен
Preparation of instructions for use - Structuring, content and presentation - Part 1: General principles and detailed requirements — 121 стр.
ISO 15223-1:2012
Заменен
Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements — 30 стр.
IEC 60417-1:2000 ed2.0
Заменен
Graphical symbols for use on equipment - Part 1: Overview and application — 179 стр.
ISO/IEC Guide 37:2012
Действует
Instructions for use of products by consumers — 32 стр.
ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
ISO 7000:2014
Действует
Graphical symbols for use on equipment -- Registered symbols — 1 стр.
ISO 11137-1:2006/Amd.1:2013
Действует
Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices -- Amendment 1 — 10 стр.
ISO/IEC Guide 41:2003
Заменен
Packaging -- Recommendations for addressing consumer needs — 12 стр.
ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.
ISO 7001:2007/Amd.4:2017
Действует
Graphical symbols -- Public information symbols -- Amendment 4 — 12 стр.
BS ISO 7010:2011
Действует
Graphical symbols. Safety colours and safety signs. Registered safety signs — 136 стр.
ISO 3864-3:2012
Действует
Graphical symbols -- Safety colours and safety signs -- Part 3: Design principles for graphical symbols for use in safety signs — 38 стр.
ISO 10993-4:2002/Amd.1:2006
Заменен
Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood -- Amendment 1 — 10 стр.
ISO 11135-1:2007
Заменен
Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — 48 стр.
ISO 9000:2015
Действует
Quality management systems -- Fundamentals and vocabulary — 58 стр.
IEC 62366-1:2015/COR1:2016 ed1.0
Действует
Corrigendum 1 - Medical devices - Part 1: Application of usability engineering to medical devices — 0 стр.
IEC 80001-1:2010 ed1.0
Заменен
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities — 86 стр.
ISO/IEC Guide 51:2014
Действует
Safety aspects -- Guidelines for their inclusion in standards — 22 стр.