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  • AAMI ISO TIR 16142 : 2005

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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    Superseded date:  05-06-2016

    Language(s):  English

    Published date:  01-01-2005

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Glossary of equivalent standards
    Committee representation
    Background of AAMI adoption of ISO/TR 16142:2005
    Forward
    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
      4.1 Basic standards
      4.2 Recognition of standards
      4.3 Conformity assessment
      4.4 Reference to basic standards
    5 Essential principles and references to relevant standards
      or guides
    6 How to find relevant standards
    Annexes
    A - Table relating essential principles to standards
    B - Examples of reference to basic standards
    C - Website listings of other standards suitable for the
        medical device sector and for assessment purposes
    D - Information on the Global Harmonization Task Force
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes certain significant standards 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 WG 02
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

    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
    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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