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  • ISO 5840-3:2013

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques

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

    Withdrawn date:  28-01-2021

    Language(s):  English, French, Russian

    Published date:  04-03-2013

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 5840-3:2013 outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests may include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.

    ISO 5840-3:2013 defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.

    ISO 5840-3:2013 is applicable to all devices intended for implantation in human hearts as a transcatheter heart valve substitute.

    ISO 5840-3:2013 is applicable to both newly developed and modified transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.

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

    Development Note Supersedes ISO/DIS 5840-3. To be read in conjunction with ISO 5840. (03/2013) Together with ISO 5840-1 & ISO 5840-2, it supersedes ISO 5840. (09/2015)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By

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

    AAMI ISO 5840-1 : 2016 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS
    I.S. EN ISO 5840-1:2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015)
    EN ISO 5840-1:2015 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
    ISO 5910:2018 Cardiovascular implants and extracorporeal systems Cardiac valve repair devices
    BS EN ISO 5840-1:2015 Cardiovascular implants. Cardiac valve prostheses General requirements
    UNE-EN ISO 5840-1:2016 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
    DIN EN ISO 5840-1:2015-12 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
    DIN EN ISO 5840-1 E : 2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 58401:2015)
    16/30310949 DC : 0 BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES
    ONORM EN ISO 5840-1 : 2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015)
    ISO 5840-1:2015 Cardiovascular implants Cardiac valve prostheses Part 1: General requirements

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

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 14160:2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
    ISO 5840:2005 Cardiovascular implants Cardiac valve prostheses
    ASTM F 2503 : 2013 : REDLINE Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 25539-1:2017 Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
    ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 14630:2012 Non-active surgical implants General requirements
    ASTM F 2052 : 2015 : REDLINE Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
    ASTM F 2213 : 2017 : REDLINE Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
    ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
    ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
    ISO/TS 11135-2:2008 Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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