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    I.S. EN 45502-2-3:2010

    Current The latest, up-to-date edition.

    ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2010

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 Symbols and abbreviations (optional)
    5 General requirements for non-implantable parts
    6 Inspection and 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) - Notes on EN 45502-2-3
    Annex BB (informative) - Notes on theoretical modelling to
             demonstrate compliance to Clause 27
    Annex CC (informative) - Notes on EMI measurements to demonstrate
             compliance to Clause 27
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES that are intended to treat hearing impairment via electrical stimulation of the auditory pathways.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

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

    AAMI PC69 : 2007
    EN 60068-2-75:2014 Environmental testing - Part 2-75: Tests - Test Eh: Hammer tests
    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    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 60118-6:1999 Hearing aids - Part 6: Characteristics of electrical input circuits for hearing aids
    HD 323.2.17 : 200S4 BASIC ENVIRONMENTAL TESTING PROCEDURES - TESTS - TEST Q: SEALING
    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
    HD 323.2.33 : 200S1 BASIC ENVIRONMENTAL TESTING PROCEDURES - TESTS - GUIDANCE ON CHANGE OF TEMPERATURE TESTS
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN 60068-2-64:2008 ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE
    EN 50061 : 88 AMD 1 95 SAFETY OF IMPLANTABLE CARDIAC PACEMAKERS
    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 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 60601-1-2:2015 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 60068-2-27:2009 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
    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
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    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
    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
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    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
    EN 45502-1 : 2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    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)
    EN 60118-6:1999 Hearing aids - Part 6: Characteristics of electrical input circuits for hearing aids
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
    IEC 60801-2:1991 Electromagnetic compatibility for industrial-process measurement and control equipment - Part 2: Electrostatic discharge requirements
    EN 60801-2 : 1993 ELECTROMAGNETIC COMPATIBILITY FOR INDUSTRIAL-PROCESS MEASUREMENT AND CONTROL EQUIPMENT - PART 2: ELECTROSTATIC DISCHARGE REQUIREMENTS (IEC 801-2:1991)
    EN 60068-2-31:2008 ENVIRONMENTAL TESTING - PART 2-31: TESTS - TEST EC: ROUGH HANDLING SHOCKS, PRIMARILY FOR EQUIPMENT-TYPE SPECIMENS
    EN 60068-2-47:2005 Environmental testing - Part 2-47: Tests - Mounting of specimens for vibration, impact and similar dynamic tests
    IEC 60068-2-56:1988 Environmental testing - Part 2: Tests. Test Cb: Damp heat, steady state, primarily for equipment
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