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  • BIS IS/ISO 14708-1 : 2000

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER

    Available format(s): 

    Superseded date:  26-09-2019

    Language(s): 

    Published date:  05-09-2013

    Publisher:  Bureau of Indian Standards

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    Abstract - (Show below) - (Hide below)

    Defines requirements that are generally applicable to active implantable medical devices.

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

    Committee MHD 7
    Development Note Issued: June 2013. (08/2013)
    Document Type Standard
    Publisher Bureau of Indian Standards
    Status Superseded
    Superseded By

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

    BIS IS/ISO 14708-3 : 2008 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS

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

    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    IEC 60068-2-47:2005 Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
    IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
    ISO 11607:2003 Packaging for terminally sterilized medical devices
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    IEC 60068-2-14:2009 Environmental testing - Part 2-14: Tests - Test N: Change of temperature
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    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 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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