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  • AAMI BE83 : 2006

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 18: CHEMICAL CHARACTERIZATION OF MATERIALS

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-08-2021

    Language(s):  English

    Published date:  01-01-2011

    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 10993-18:2005 and
    rationale for major technical deviations
    Major technical deviations from ISO 10993-18:2005
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Symbols and abbreviated terms
    5 General principles
    6 Characterization procedure
      6.1 General
      6.2 Qualitative information
      6.3 Quantitative information
    7 Chemical characterization parameters and methods
      7.1 General
      7.2 Polymers
      7.3 Metals and alloys
      7.4 Ceramics
      7.5 Natural macromolecules
    8 Reporting of data obtained
    Annex A (informative) - Information sources for chemical
                            characterization
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines a framework for the identification of a material and the identification and quantification of its chemical constituents.

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

    Committee WG 14
    Document Type Standard
    Product Note Reconfirmed 2006
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

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

    EN 12442-3 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
    ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
    ISO 5832-1:2016 Implants for surgery — Metallic materials — Part 1: Wrought stainless steel
    ISO 10993-13:2010 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
    ISO 10993-14:2001 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    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 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN 12442-2 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
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