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  • CEN/TR 15640:2007

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Health informatics - Measures for ensuring the patient safety of health software

    Available format(s): 

    Withdrawn date:  16-11-2017

    Language(s): 

    Published date:  08-08-2007

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Terms and definitions
    3 Symbols and abbreviations
    4 Outline of the issues
    5 General position on medical device controls
    6 The border between health software products and
       medical devices
    7 Classifying health software products
    8 Options for control measures for health software
       products
    9 Standards specific to risks of a particular nature
    10 Observation on safety and risks in the user domain
    11 Taxonomies
    12 Summary of conclusions
    Annex A (informative) - Position regarding medical
            devices in different countries
    Annex B (informative) - Analysis of classification
            procedures
    Annex C (informative) - Risk management
    Bibliography

    Abstract - (Show below) - (Hide below)

    This document considers the control measures required to ensure patient safety in respect to health software products. It does not apply to software which is:necessary for the proper application of a medical device orwhich is an accessory to a medical device orwhich is a medical device in its own right. The document is aimed at identifying what standards might best be used or created, and their nature, if health software products were to be regulated or controlled in some other formal or informal or voluntary manner whether national, regional or local. However it is not the purpose of this document to recommend whether or not health software products should be regulated. This document applies to any health software product whether or not it is placed on the market and whether or not it is for sale or free of charge. It is addressed to manufacturers of health software products.NOTEThe scope is intended to cover health software products which are not, in practice, covered by medical device regulations. Annex A considers this matter in detail. This TR acknowledges that, on the boundary, there are health software products which are encompassed by medical device regulations in some countries but not in others and that some definitions of medical devices may appear to cover health software products in general but in practice do not.

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

    Committee CEN/TC 251
    Document Type Technical Report
    Publisher Comite Europeen de Normalisation
    Status Withdrawn

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

    ISO/IEC 27001:2013 Information technology — Security techniques — Information security management systems — Requirements
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    IEC 61508-5:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 5: Examples of methods for the determination of safety integrity levels (see Functional Safety and IEC 61508)
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
    IEC 61508-3:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (see Functional Safety and IEC 61508)
    PD 6668:2000 MANAGING RISK FOR CORPORATE GOVERNANCE
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    ISO/TS 19218:2005 Medical devices Coding structure for adverse event type and cause
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    AS/NZS 4360:2004 Risk management
    ISO/IEC 12207:2008 Systems and software engineering Software life cycle processes
    ISO 9001:2015 Quality management systems — Requirements
    ISO/IEC TR 15271:1998 Information technology Guide for ISO/IEC 12207 (Software Life Cycle Processes)
    CEN/TS 15260:2006 Health informatics - Classification of safety risks from health informatics products
    ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
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