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  • 11/30243761 DC : 0

    Current The latest, up-to-date edition.

    BS ISO 14708-7 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 Symbols and abbreviations (optional)
    5 General requirements for non-implantable parts
    6 Measurement
    7 General arrangement of the packaging
    8 General markings for active implantable medical
       devices
    9 Markings on the SALES PACKAGING
    10 Construction of the SALES PACKAGING
    11 Markings on the sterile pack
    12 Construction of the non-reusable pack
    13 Markings on the active implantable medical device
    14 Protection from unintentional biological effects
       being caused by the active implantable medical device
    15 Protection from harm to the patient or user caused
       by external physical features of the active
       implantable medical device
    16 Protection from harm to the patient caused by
       electricity
    17 Protection from harm to the patient caused by heat
    18 Protection from ionizing radiation released or
       emitted from the active implantable
       medical device
    19 Protection from unintended effects caused by the
       device
    20 Protection of the device from damage caused by
       external defibrillators
    21 Protection of the device from changes caused
       by high power electrical fields applied
       directly to the patient
    22 Protection of the active implantable medical
       device from changes caused by miscellaneous
       medical treatments
    23 Protection of the active implantable medical
       device from mechanical forces
    24 Protection of the active implantable medical
       device from damage caused by electrostatic
       discharge
    25 Protection of the active implantable medical
       device from damage caused by atmospheric
       pressure changes
    26 Protection of the active implantable medical
       device from damage caused by temperature
       changes
    27 Protection of the active implantable medical
       device from electromagnetic non-ionising
       radiation
    28 Accompanying documentation
    Annex AA (informative) - Relationship between
             the fundamental principles in ISO/TR 14283
             and the clauses of this standard
    Annex BB (informative) - Relationship between
             the clauses of this standard and the
             fundamental principles listed in Annex A
    Annex CC (informative) - Notes on EN 45502-2-3
    Annex DD (informative) - Notes on theoretical modelling
             to demonstrate compliance to Clause 27
    Annex EE (informative) - Notes on EMI measurements to
             demonstrate compliance to Clause 27
    Bibliography

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

    Comment Closes On
    Committee CH/150/2
    Document Type Draft
    Publisher British Standards Institution
    Status Current

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

    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
    AAMI PC69 : 2007
    IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
    IEC 60118-6:1999 Hearing aids - Part 6: Characteristics of electrical input circuits for hearing aids
    EN 1593:1999/A1:2003 NON-DESTRUCTIVE TESTING - LEAK TESTING - BUBBLE EMISSION TECHNIQUES
    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
    IEC 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
    IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
    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 5841-2:2014 Implants for surgery Cardiac pacemakers Part 2: Reporting of clinical performance of populations of pulse generators or leads
    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
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    EN 13185:2001/A1:2003 NON-DESTRUCTIVE TESTING - LEAK TESTING - TRACER GAS METHOD
    ASTM F 2052 : 2015 : REDLINE Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
    IEC 60068-2-47:2005 Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests
    ISO 14708-2:2012 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers
    IEC 60068-2-17:1994 Basic environmental testing procedures - Part 2-17: Tests - Test Q: Sealing
    ASTM F 2213 : 2017 : REDLINE Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
    IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    IEC 60068-2-75:2014 Environmental testing - Part 2-75: Tests - Test Eh: Hammer tests
    CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    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 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
    IEC 60068-2-56:1988 Environmental testing - Part 2: Tests. Test Cb: Damp heat, steady state, primarily for equipment
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