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  • UNE-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):  Spanish, Castilian, English

    Published date:  21-07-2010

    Publisher:  Asociacion Espanola de Normalizacion

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

    Committee CTN 209/SC 62
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    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
    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
    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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