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  • 13/30233325 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS EN 45502-1 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-06-2015

    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 Terms and definitions
    4 Symbols and abbreviations (optional)
    5 General requirements for ACTIVE IMPLANTABLE
       MEDICAL DEVICES
    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 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 ACTIVE
       IMPLANTABLE MEDICAL DEVICE
    20 Protection of the ACTIVE IMPLANTABLE MEDICAL
       DEVICE from damage caused by external defibrillators
    21 Protection of the ACTIVE IMPLANTABLE MEDICAL
       DEVICE from changes caused by 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 A (informative) - General guidance and rationale
    Annex ZZ (informative) - Coverage of Essential Requirements
             of EU Directives
    Bibliography

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

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    Status Superseded
    Superseded By

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

    IEC 62127-1:2007+AMD1:2013 CSV Ultrasonics - Hydrophones - Part 1: Measurement and characterizationof medical ultrasonic fields up to 40 MHz
    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
    EN 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 (ISO 14937:2009)
    IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    EN ISO 14155:2011/AC:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
    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
    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
    EN 50061 : 88 AMD 1 95 SAFETY OF IMPLANTABLE CARDIAC PACEMAKERS
    EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
    IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    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
    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 60068-2-27:2009 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    IEC 60068-2-47:2005 Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests
    EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    EN 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 11135-1:2007)
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
    EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO/TS 10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    EN 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 (ISO 17665-1:2006)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    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
    EN 60068-2-14:2009 Environmental testing - Part 2-14: Tests - Test N: Change of temperature
    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 62127-1:2007/A1:2013 ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ (IEC 62127-1:2007/A1:2013)
    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
    EN 60068-2-47:2005 Environmental testing - Part 2-47: Tests - Mounting of specimens for vibration, impact and similar dynamic tests
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