Skip to content
Please enter a keyword to search

  • ISO/TS 20405:2018

    Current The latest, up-to-date edition.

    Health informatics Framework of event data and reporting definitions for the safety of health software

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

    Language(s):  English

    Published date:  18-05-2018

    Publisher:  International Organization for Standardization

    Add To Cart

    Abstract - (Show below) - (Hide below)

    This document provides a model framework for improving the surveillance and reporting of events with respect to the safety of health software.

    This document defines those data elements needed for identification of particular events including incidents, near-misses and unsafe conditions, as well as outlining good principles, relevant concepts and a process model for the recording, analysis and reporting of event-specific information related to the safety of health software.

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

    Document Type Technical Specification
    Publisher International Organization for Standardization
    Status Current

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

    IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
    ISO/TR 27809:2007 Health informatics Measures for ensuring patient safety of health software
    ISO 31000:2009 Risk management Principles and guidelines
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO/IEC 27005:2011 Information technology Security techniques Information security risk management
    ISO/TR 17791:2013 Health informatics Guidance on standards for enabling safety in health software
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO/TS 25238:2007 Health informatics Classification of safety risks from health software
    ISO Guide 73:2009 Risk management — Vocabulary
    View more information

    • 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