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  • AAMI ISO TIR 19218-2 : 2012

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL DEVICES - HIERARCHICAL CODING STRUCTURE FOR ADVERSE EVENTS - PART 2: EVALUATION CODES

    Available format(s):  Hardcopy, PDF

    Superseded date:  15-07-2018

    Language(s):  English

    Published date:  01-01-2012

    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 AAMI adoption of ISO/TS 19218-2:2012
    Foreword
    Introduction
    1 Scope
    2 Terms and definitions
    3 Adverse event evaluation code requirements
    4 Adverse event evaluation codes
    Annex A - Coding system structure
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements for a hierarchical coding structure for characterizing the results of the analysis or evaluation of adverse events relating to medical devices.

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

    Committee ISO/TC 210
    Development Note Supersedes AAMI ISO TIR 19218. (12/2012)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

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

    ISO/TS 19218-1:2011 Medical devices Hierarchical coding structure for adverse events Part 1: Event-type codes
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 15225:2016 Medical devices Quality management Medical device nomenclature data structure
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