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  • ISO/TR 27809:2007

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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

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

    Withdrawn date:  15-07-2021

    Language(s):  English

    Published date:  11-07-2007

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO/TR 27809:2007 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
    • an accessory to a medical device or
    • a medical device in its own right.

    ISO/TR 27809:2007 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 ISO/TR 27809:2007 to recommend whether or not health software products should be regulated.

    ISO/TR 27809:2007 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.

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

    Document Type Technical Report
    Publisher International Organization for Standardization
    Status Withdrawn

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

    AAMI IEC TIR 80001-2-2 : 2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-2: GUIDANCE FOR THE DISCLOSURE AND COMMUNICATION OF MEDICAL DEVICE SECURITY NEEDS, RISKS AND CONTROLS
    PD ISO/IEC/TR 15026-1:2010 Systems and software engineering. Systems and software assurance Concepts and vocabulary
    ISO/IEEE 11073-00103:2015 Health informatics Personal health device communication Part 00103: Overview
    BS ISO/IEEE 11073-00103 : 2015 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW
    CSA ISO/IEC TR 15026-1 : 2013 SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE ASSURANCE - PART 1: CONCEPTS AND VOCABULARY
    CSA ISO/IEC 15026-1 : 2015 SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE ASSURANCE - PART 1: CONCEPTS AND VOCABULARY
    I.S. EN ISO 11073-00103:2017 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015)
    ISO/IEC 15026-1:2013 Systems and software engineering Systems and software assurance Part 1: Concepts and vocabulary
    ISO/TR 17522:2015 Health informatics Provisions for health applications on mobile/smart devices
    PD IEC/TR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices Guidance for the disclosure and communication of medical device security needs, risks and controls
    BS ISO/IEC 15026-1:2013 Systems and software engineering. Systems and software assurance Concepts and vocabulary
    13/30268559 DC : 0 BS ISO/IEC 15026-1 - SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE ASSURANCE - PART 1: CONCEPTS AND VOCABULARY
    BS EN ISO 11073-00103:2017 Health informatics. Personal health device communication Overview
    ISO/TS 20405:2018 Health informatics Framework of event data and reporting definitions for the safety of health software
    ISO/IEC TR 15026-1:2010 Systems and software engineering Systems and software assurance Part 1: Concepts and vocabulary
    IEC TR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
    EN ISO 11073-00103:2017 Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015)
    PD ISO/TR 17522:2015 Health informatics. Provisions for health applications on mobile/smart devices
    IEEE 11073-00103-2012 Health informatics - Personal health device communication Part 00103: Overview
    IEEE/ISO/IEC 15026-1-2014 IEEE Standard Adoption of ISO/IEC 15026-1--Systems and Software Engineering--Systems and Software Assurance--Part 1: Concepts and Vocabulary

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

    ISO/IEC 27001:2013 Information technology — Security techniques — Information security management systems — Requirements
    ISO/TS 22224:2009 Health informatics Electronic reporting of adverse drug reactions
    BS 7799-3:2006 Information security management systems Guidelines for information security risk management
    EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
    ISO 31000:2009 Risk management Principles and guidelines
    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 27005:2011 Information technology Security techniques Information security risk management
    ISO/IEC 12207:2008 Systems and software engineering Software life cycle processes
    ISO/IEC 17799:2005 Information technology Security techniques Code of practice for information security management
    ISO 9001:2015 Quality management systems — Requirements
    ISO/IEC TR 15271:1998 Information technology Guide for ISO/IEC 12207 (Software Life Cycle Processes)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    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
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
    ISO/TS 25238:2007 Health informatics Classification of safety risks from health software
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