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  • ANSI/AAMI CI86:2017

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    COCHLEAR IMPLANT SYSTEMS: REQUIREMENTS FOR SAFETY, FUNCTIONAL VERIFICATION, LABELING AND RELIABILITY REPORTING

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2017

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Glossary of equivalent standards
    Committee representation
    Acknowledgments
    Foreword
    1 Scope
    2 Normative references
    3 Definitions
    4 Units, abbreviations, and symbols
    5 General requirements for characterizing a
       cochlear implant system
    6 General requirements for implantable parts
    7 General requirements for non-implantable parts
    8 System-level inspection, characterization, and
       measurement
    9 Implantation support (RESERVED FOR FUTURE
       VERSIONS)
    10 Post-implantation testing, in vivo assessment,
       and analysis of failed devices
    11 Reliability monitoring and reporting
    12 Information on use, warnings, and hazards
    13 General arrangement of the packaging system
    14 Markings on the packaging system and the
       cochlear implant device
    15 Safety from unintentional biological effects
       of the cochlear implant system
    16 Safety of secondary features of the cochlear
       implant system
    17 Safety of electrical stimulation
    18 Safety of implantable energy sources
    19 Safety from heat sources
    20 Safety from unintended effects caused by the
       device
    21 Safety and device immunity during magnetic
       resonance imaging
    22 Device immunity to external stresses caused by
       medical treatment and procedures
    23 Device immunity to stresses of mechanical forces
    24 Device immunity to stresses caused by atmospheric
       pressure changes
    25 Device immunity to stresses caused by temperature
       changes
    26 Non-implantable device immunity to stresses caused
       by environment and usage
    Annex A (informative) - Clinical identification and
            management of cochlear implant device failures
    Annex B (informative) - Clinical checklist prior to
            explantation Signs and symptoms checklist
    Annex C (informative) - Returned implant analysis
    Annex D (informative) - Indications of performance declin
    Annex E (informative) - Reliability reporting to regulato
            bodies
    Annex F (informative) - Pareto analysis
    Annex G (informative) - Failed component return rate
            (FCRR) graphic and table
    Annex H (informative) - Reliability reporting template
            for the public and clinical community
    Annex I (informative) - Product specification data
            sheets
    Annex J (informative) - Mechanical testing of leads
            and interfaces to case bodies
    Annex K (informative) - Logic flow diagram of
            the relationships between the required
            testing, explant category classification, and
            reliability reporting to both regulatory bodies
            and the public
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements, test procedures, methods and labeling for active implantable medical devices intended to treat hearing impairment by means of electrical stimulation of the cochlea.

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

    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current

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

    ISO 14708-7:2013 Implants for surgery Active implantable medical devices Part 7: Particular requirements for cochlear implant systems
    IEC 62281:2016 Safety of primary and secondary lithium cells and batteries during transport
    MIL-STD-883 Revision K:2016 TEST METHOD STANDARD - MICROCIRCUITS
    IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
    IEC 61649:2008 Weibull analysis
    EN 60068-2-1:2007 Environmental testing - Part 2-1: Tests - Test A: Cold
    EN 1593:1999/A1:2003 NON-DESTRUCTIVE TESTING - LEAK TESTING - BUBBLE EMISSION TECHNIQUES
    ASTM F 2503 : 2013 : REDLINE Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    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
    IEC 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
    IEEE 1413 : 2010 FRAMEWORK FOR RELIABILITY PREDICTION OF HARDWARE
    IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
    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
    AS/NZS ISO 8124.1:2013 Safety of toys Safety aspects related to mechanical and physical properties
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    EN 13185:2001/A1:2003 NON-DESTRUCTIVE TESTING - LEAK TESTING - TRACER GAS METHOD
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    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 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    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 14708-3:2017 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    ASTM F 2213 : 2017 : REDLINE Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
    IEC 60300-1:2014 Dependability management - Part 1: Guidance for management and application
    IEC 60068-2-2:2007 Environmental testing - Part 2-2: Tests - Test B: Dry heat
    AS 1647.2-1992 Children’s toys (Safety requirements) Constructional requirements
    IEC 60118-15:2012 Electroacoustics - Hearing aids - Part 15: Methods for characterising signal processing in hearing aids with a speech-like signal
    ISO/TS 10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    IEC 60068-2-75:2014 Environmental testing - Part 2-75: Tests - Test Eh: Hammer tests
    ANSI/AAMI/ISO TIR16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
    IEC 62133 : 2.0EN+(REDLINE+VERSION) SECONDARY CELLS AND BATTERIES CONTAINING ALKALINE OR OTHER NON-ACID ELECTROLYTES - SAFETY REQUIREMENTS FOR PORTABLE SEALED SECONDARY CELLS, AND FOR BATTERIES MADE FROM THEM, FOR USE IN PORTABLE APPLICATIONS
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    IEC 60086-4:2014 Primary batteries - Part 4: Safety of lithium batteries
    EN 45502-2-1:2003 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
    ASTM F 963 : 2017 : REDLINE Standard Consumer Safety Specification for Toy Safety
    IEC 60068-2-14:2009 Environmental testing - Part 2-14: Tests - Test N: Change of temperature
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    IEC 60118-0:2015 Electroacoustics - Hearing aids - Part 0: Measurement of the performance characteristics of hearing aids
    IEC 60601-2-66:2015 Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
    IEC 60068-2-30:2005 Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle)
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