Name: 10/30208681 DC : DRAFT SEP 2010
Brand: BSI

BS ISO/IEC GUIDE 63 - GUIDE TO THE DEVELOPMENT AND INCLUSION OF SAFETY ASPECTS IN INTERNATIONAL STANDARDS FOR MEDICAL DEVICES

Published date

11-23-2012

Publisher

British Standards Institution

BS ISO/IEC GUIDE 63

Committee	CH/210/4
DocumentType	Draft
PublisherName	British Standards Institution
Status	Current

Standards	Relationship
ISO/IEC Guide 63:2012	Identical

ISO 11137-1:2006	Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 5840:2005	Cardiovascular implants Cardiac valve prostheses
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
IEC 62366:2007+AMD1:2014 CSV	Medical devices - Application of usability engineering to medical devices
ISO 11135-1:2007	Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO/IEC Guide 51:2014	Safety aspects Guidelines for their inclusion in standards
ISO 10993-17:2002	Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO 14971:2007	Medical devices Application of risk management to medical devices

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