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  • BIS IS/ISO 14708-3 : 2008

    Current The latest, up-to-date edition.

    IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS

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    Published date:  05-09-2013

    Publisher:  Bureau of Indian Standards

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

    NATIONAL FOREWORD
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Symbols and abbreviated terms
    5 General requirements for non-implantable parts
    6 Requirements for particular active implantable medical
       devices
    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 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-ionizing radiation
    28 Accompanying documentation
    Annex AA (informative) - Relationship between the fundamental
             principles in ISO/TR 14283 [8] and the clauses of this
             part of ISO 14708
    Annex BB (informative) - Relationship between the clauses of
             this part of ISO 14708 and the fundamental principles
             listed in Annex AA
    Annex CC (informative) - Rationale
    Bibliography

    Abstract - (Show below) - (Hide below)

    Pertains to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.

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

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

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

    CISPR 14-1:2016 Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus - Part 1: Emission
    IEC TR 61000-2-7:1998 Electromagnetic compatibility (EMC) - Part 2: Environment - Section 7: Low frequency magnetic fields in various environments
    AAMI PC69 : 2007
    ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    BIS IS 13450-1-2 : 2012(R2017) MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - SECTION 2: COLLATERAL STANDARD: ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS
    IEC TR 61000-2-3:1992 Electromagnetic compatibility (EMC) - Part 2: Environment - Section 3: Description of the environment - Radiated and non-network-frequency-related conducted phenomena
    CFR 47(PTS0-19) : OCT 2017 TELECOMMUNICATION - FEDERAL COMMUNICATIONS COMMISSION
    CISPR 22:2008 Information technology equipment - Radio disturbance characteristics - Limits and methods of measurement
    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
    ISO/TR 14283:2004 Implants for surgery Fundamental principles
    ISO 780:2015 Packaging Distribution packaging Graphical symbols for handling and storage of packages
    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
    MIL-STD-461 Revision G:2015 REQUIREMENTS FOR THE CONTROL OF ELECTROMAGNETIC INTERFERENCE CHARACTERISTICS OF SUBSYSTEMS AND EQUIPMENT
    IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
    IEEE C95.1-2005 IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    BIS IS 13450-1 : 2008 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
    BIS IS/ISO 14708-1 : 2000 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
    IEC 62226-2-1:2004 Exposure to electric or magnetic fields in the low and intermediate frequency range - Methods for calculating the current density and internal electric field induced in the human body - Part 2-1: Exposure to magnetic fields - 2D models
    IEEE C95.6-2002 IEEE Standard for Safety Levels With Respect to Human Exposure to Electromagnetic Fields, 0-3 kHz
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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