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  • ANSI/AAMI/ISO 10993-12:2012

    Current The latest, up-to-date edition.

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  26-07-2012

    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 10993-12:2012
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Reference materials (RMs)
    6 Use of RMs as experimental controls
    7 Test sample selection
    8 Test sample and RM preparation
    9 Selection of representative portions from a device
    10 Preparation of extracts of samples
    11 Records
    Annex A (informative) - Experimental controls
    Annex B (informative) - General principles on, and
            practices of, test sample preparation and
            sample selection
    Annex C (informative) - Principles of test sample extraction
    Annex D (informative) - Exhaustive extraction of polymeric
            materials for biological evaluation
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements and provides guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993.

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

    Committee WG 12
    Development Note Supersedes AAMI ISO 10993 8 (01/2005)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    Supersedes

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

    AAMI TIR14 : 2016 CONTRACT STERILIZATION USING ETHYLENE OXIDE
    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 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    ISO Guide 33:2015 Reference materials Good practice in using reference materials
    ISO Guide 35:2017 Reference materials Guidance for characterization and assessment of homogeneity and stability
    ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO Guide 30:2015 Reference materials Selected terms and definitions
    CFR 40(PTS700-789) : JUL 2016 PROTECTION OF ENVIRONMENT - ENVIRONMENTAL PROTECTION AGENCY
    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 Guide 31:2015 Reference materials — Contents of certificates, labels and accompanying documentation
    NFS 90 701 : 1988 MEDICO-SURGICAL EQUIPMENT - BIOCOMPATIBILITY OF MATERIALS AND MEDICAL DEVICES
    ISO Guide 34:2009 General requirements for the competence of reference material producers
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