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  • ANSI/AAMI/ISO TIR10993-20:2006

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 20: PRINCIPLES AND METHODS FOR IMMUNOTOXICOLOGY TESTING OF MEDICAL DEVICES

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  09-04-2024

    Language(s):  English

    Published date:  05-09-2005

    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/TS 10993-20
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Risk assessment and risk management
    5 Identification of hazards
    6 Methods of assessment of immunotoxicity
      6.1 General
      6.2 Inflammation
      6.3 Immunosuppression
      6.4 Immunostimulation
      6.5 Hypersensitivity
      6.6 Auto-immunity
    7 Extrapolation of data provided by pre-clinical assays
    Annex A (informative) Current state of knowledge
    Annex B (informative) Clinical experience with medical
            devices
    Annex C (informative) Flow chart for immunotoxicity testing
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives an overview of immunotoxicology with particular reference to the potential immunotoxicity of medical devices.

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    Committee WG 07
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Withdrawn
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    AAMI TIR17 : 2008 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
    AAMI TIR17 : 2017 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION

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

    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
    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
    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
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