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  • ISO/TS 25238:2007

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 Classification of safety risks from 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    Withdrawn date:  15-07-2021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:  04-06-2007

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO/TS 25238:2007 is concerned with the safety of patients and gives guidance on the analysis and categorization of hazards and risks to patients from health software products, in order to allow any product to be assigned to one of five risk classes. It applies to hazards and risks which could cause harm to a patient. Other risks, such as financial or organizational risks, are outside the scope of ISO/TS 25238:2007 unless they have the potential to harm a patient.

    ISO/TS 25238:2007 applies to any health software product, whether or not it is placed on the market and whether it is for sale or free of charge. Examples of the application of the classification scheme are given.

    ISO/TS 25238:2007 does not apply to any software which is necessary for the proper application or functioning of a medical device.

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

    Document Type Technical Specification
    Publisher International Organization for Standardization
    Status Withdrawn

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

    BS EN ISO 13119:2012 Health informatics. Clinical knowledge resources. Metadata
    ISO/IEC 15026-1:2013 Systems and software engineering Systems and software assurance Part 1: Concepts and vocabulary
    PD ISO/IEC/TR 15026-1:2010 Systems and software engineering. Systems and software assurance Concepts and vocabulary
    I.S. EN ISO 13119:2012 HEALTH INFORMATICS - CLINICAL KNOWLEDGE RESOURCES - METADATA (ISO 13119:2012)
    ISO/IEEE 11073-00103:2015 Health informatics Personal health device communication Part 00103: Overview
    EN ISO 13119:2012 Health informatics - Clinical knowledge resources - Metadata (ISO 13119:2012)
    CEN/TS 15699:2009 Health informatics - Clinical knowledge resources - Metadata
    PD ISO/TS 17938:2014 Health informatics. Semantic network framework of traditional Chinese medicine language system
    ISO/TR 27809:2007 Health informatics Measures for ensuring patient safety of health software
    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
    11/30211693 DC : 0 BS EN ISO 13119 - HEALTH INFORMATICS - CLINICAL KNOWLEDGE RESOURCES - METADATA
    CSA ISO/IEC TR 15026-1 : 2013 SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE ASSURANCE - PART 1: CONCEPTS AND VOCABULARY
    UNI CEN/TS 15699 : 2009 HEALTH INFORMATICS - CLINICAL KNOWLEDGE RESOURCES - METADATA
    CSA ISO/IEC 15026-1 : 2015 SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE ASSURANCE - PART 1: 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
    IEEE 15026-3-2013 IEEE Standard Adoption of ISO/IEC 15026-3 -- Systems and Software Engineering -- Systems and Software Assurance -- Part 3: System Integrity Levels
    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
    I.S. EN ISO 11073-00103:2017 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015)
    ISO/TS 17938:2014 Health informatics Semantic network framework of traditional Chinese medicine language system
    BS ISO/IEEE 11073-00103 : 2015 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW
    PD ISO/TR 27809:2007 Health informatics. Measures for ensuring patient safety of health software
    10/30230297 DC : 0 BS ISO/IEC 15026-3 - SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE ASSURANCE - PART 3: SYSTEM INTEGRITY LEVELS
    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 EN ISO 11073-00103:2017 Health informatics. Personal health device communication Overview
    S.R. CEN TS 15699:2009 HEALTH INFORMATICS - CLINICAL KNOWLEDGE RESOURCES - METADATA
    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
    ISO 13119:2012 Health informatics — Clinical knowledge resources — Metadata
    EN ISO 11073-00103:2017 Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015)
    BS ISO/IEC 15026-1:2013 Systems and software engineering. Systems and software assurance Concepts and vocabulary
    UNI EN ISO 13119 : 2013 HEALTH INFORMATICS - CLINICAL KNOWLEDGE RESOURCES - METADATA
    DD CEN/TS 15699:2009 Health informatics. Clinical knowledge resources. Metadata
    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)

    EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
    IEC 61508-4:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 4: Definitions and abbreviations (see Functional Safety and IEC 61508)
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    AS/NZS 4360:2004 Risk management
    ISO/IEC Guide 73:2002 Risk management Vocabulary Guidelines for use in standards
    ISO/IEC 17799:2005 Information technology Security techniques Code of practice for information security management
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
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