• AAMI ISO 10993-11 : 2006 : R2014

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY

    Available format(s): 

    Superseded date:  21-02-2019

    Language(s): 

    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 AAMI adoption of ISO 10993-11:2006
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General considerations
    5 Acute systemic toxicity
    6 Repeated exposure systemic toxicity (subacute,
      subchronic and chronic systemic toxicity)
    Annex A (informative) - Routes of administration
    Annex B (informative) - Dosage volumes
    Annex C (informative) - Common clinical signs and
            observations
    Annex D (informative) - Suggested haematology, clinical
            chemistry and urinalysis measurements
    Annex E (informative) - Suggested organ list for
            histopathological evaluation
    Annex F (informative) - Information on material-mediated
            pyrogens
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

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

    Committee WG 07
    Development Note Supersedes AAMI 10993 11. (09/2009)
    Document Type Standard
    Product Note Reconfirmed 2014
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

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

    SN 119800 : 1990 BIOLOGICAL EVALUATION OF DENTAL MATERIALS
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ASTM F 619 : 2014 : REDLINE Standard Practice for Extraction of Medical Plastics
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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