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  • 10/30208681 DC : DRAFT SEP 2010

    Current The latest, up-to-date edition.

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

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    Published date:  23-11-2012

    Publisher:  British Standards Institution

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    Comment Closes On
    Committee CH/210/4
    Document Type Draft
    Publisher British Standards Institution
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    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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