• ISO/TS 19218:2005

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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

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

    Withdrawn date:  15-03-2019

    Language(s):  English, French, Russian

    Published date:  03-11-2005

    Publisher:  International Organization for Standardization

    Add To Cart

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

    Foreword
    Introduction
    1 Scope
    2 Terms and definitions
    3 Code system and requirements
      3.1 Adverse event type code
      3.2 Adverse event cause code
    Annex A (informative) Coding system for describing adverse events
    Annex B (informative) Examples of coding
    Bibliography

    Abstract - (Show below) - (Hide below)

    ISO/TS 19218:2005 specifies requirements for a coding structure for describing adverse events related to medical devices. This code is intended for use by medical device users, manufacturers and regulatory authorities.

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

    Document Type Technical Specification
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By

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

    ISO/TR 27809:2007 Health informatics Measures for ensuring patient safety of health software
    CEN/TR 15640:2007 Health informatics - Measures for ensuring the patient safety of health software
    PD ISO/TR 27809:2007 Health informatics. Measures for ensuring patient safety of health software
    PD CEN/TR 15640:2007 Health informatics. Measures for ensuring the patient safety of health software
    14/30302761 DC : 0 BS ISO 11249 - MECHANICAL CONTRACEPTIVES - GUIDANCE FOR CLINICAL EVALUATION OF INTRA-UTERINE CONTRACEPTIVE DEVICES (IUDS)
    MEDDEV 2.12-1 : REV 8 : 2013 GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
    S.R. CEN TR 15640:2007 HEALTH INFORMATICS - MEASURES FOR ENSURING THE PATIENT SAFETY OF HEALTH SOFTWARE

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

    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective