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  • BS EN ISO 10993-18:2009

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Available format(s):  Hardcopy, PDF

    Superseded date:  14-12-2020

    Language(s):  English

    Published date:  30-06-2009

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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 Step 1 - Qualitative information
      6.3 Step 2 - Material equivalence
      6.4 Step 3 - Quantitative information
      6.5 Step 4 - Quantitative risk assessment
      6.6 Step 5 - Estimated clinical exposure to chemicals
          present
    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 (normative) - Flowchart summarizing the stepwise
            generation of chemical characterization data for
            use in toxicological risk assessment
    Annex B (informative) - Information sources for chemical
            characterization
    Annex C (informative) - Principles for judging toxicological
            equivalency
    Bibliography
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC on Medical Devices
    Annex ZB (informative) - Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 90/385/EEC on Active Implantable
             Medical Devices

    Abstract - (Show below) - (Hide below)

    Specifies 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 CH/194
    Development Note Supersedes 03/100426 DC. (11/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    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 10993-17:2002 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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