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  • AAMI ISO 10993-16 : 2010 : R2014

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES

    Available format(s):  Hardcopy, PDF

    Superseded date:  02-01-2018

    Language(s):  English

    Published date:  01-01-2014

    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 ANSI/AAMI adoption of ISO 10993-16:2010
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Principles for design of toxicokinetic studies
    5 Guidance on test methods
    Annex A (normative) - Circumstances in which toxicokinetic
            studies shall be considered
    Bibliography

    Abstract - (Show below) - (Hide below)

    Provides principles on how toxicokinetic studies relevant to medical devices should be designed and performed.

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

    Committee WG 13
    Document Type Standard
    Product Note Reconfirmed 2014
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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