• 08/30192448 DC : DRAFT DEC 2008

    Current The latest, up-to-date edition.

    BS ISO 14708-5 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES

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    Published date:  23-11-2012

    Publisher:  British Standards Institution

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    Comment Closes On
    Committee CH/150/6
    Document Type Draft
    Publisher British Standards Institution
    Status Current

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

    ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
    IEC 60068-1:2013 Environmental testing - Part 1: General and guidance
    IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
    ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    ISO 5840:2005 Cardiovascular implants Cardiac valve prostheses
    ISO 7198:2016 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    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 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    IEC 60300-3-2:2004 Dependability management - Part 3-2: Application guide - Collection of dependability data from the field
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    ISO 14708-1:2014 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 5198:1987 Centrifugal, mixed flow and axial pumps Code for hydraulic performance tests Precision grade
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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