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  • AAMI ISO 10993-9 : 2009

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-08-2021

    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 10993-9:2009
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Principles for design of degradation studies
    5 Study report
    Annex A (normative) - Consideration of the need for
            degradation studies
    Annex B (informative) - Biodegradation study
            considerations
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies.

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

    Committee WG 02
    Document Type Standard
    Product Note Reconfirmed 2009
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

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

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
    ISO 10271:2011 Dentistry Corrosion test methods for metallic materials
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 10993-14:2001 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
    ISO 13781:2017 Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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