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    ISO/TS 19218-2:2012

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Medical devices Hierarchical coding structure for adverse events Part 2: Evaluation codes

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  23-09-2021

    Language(s):  English

    Published date:  20-03-2012

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO/TS 19218-2:2012 specifies requirements for a hierarchical coding structure for characterizing the results of the analysis or evaluation of adverse events relating to medical devices. The codes are intended primarily for use by medical device manufacturers and regulatory authorities. They can also be used for coding the results of the analysis or evaluation of events other than those related to death or serious injury, as well as malfunctions that could lead to death or serious injury.

    ISO/TS 19218-2:2012 is not intended to be used to decide whether or not an incident is reportable.

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

    Development Note Together with ISO TS 19218-1, Supersedes ISO TS 19218. (03/2012)
    Document Type Technical Specification
    Product Note THIS STANDARD ALSO REFERS TO GHTF/SG2/N54/R8:2006,GHTF/SG1/N41/R9:2005,GHTF/SG2/N31/R8:2003,GHTF/SG2/N21/R8:1999
    Publisher International Organization for Standardization
    Status Withdrawn
    Supersedes

    Standards Referenced By 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 TR 80001-2-1:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples
    PD IEC/TR 80001-2-1:2012 Application of risk management for IT-networks incorporating medical devices Step-by-step risk management of medical IT-networks. Practical applications and examples
    ANSI/AAMI/IEC TIR80001-2-1:2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-1: STEP BY STEP RISK MANAGEMENT OF MEDICAL IT-NETWORKS - PRACTICAL APPLICATIONS AND EXAMPLES
    AAMI ISO TIR 19218-1 : 2011 MEDICAL DEVICES - HIERARCHAL CODING STRUCTURE FOR ADVERSE EVENTS - PART 1: EVENT-TYPE CODES

    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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