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  • PD ISO/TR 16142:2006

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-03-2016

    Language(s):  English

    Published date:  03-02-2006

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Terms and definitions
    3 Essential principles of safety and performance of medical
      devices
    4 Use of standards and guides in support of regulatory
      requirements
    5 Essential principles and references to relevant standards
      or guides
    6 How to find relevant standards
    Annex A (informative) Table relating essential principles
            to standards
    Annex B (informative) Examples of reference to basic
            standards
    Annex C (informative) Website listings of other standards
            suitable for the medical device sector and for
            assessment purposes
    Annex D (informative) Information on the Global
            Harmonization Task Force
    Bibliography

    Abstract - (Show below) - (Hide below)

    Considers and identifies certain significant standards and guides that can be useful in the assessment of conformity of medical devices with recognized essential principles of safety and performance.

    General Product Information - (Show below) - (Hide below)

    Committee CH/210
    Development Note Supersedes 05/30080067 DC. (03/2006)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 14160:2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
    IEC TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
    ISO/IEC Guide 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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