Skip to content
Please enter a keyword to search

  • ANSI/AAMI/ISO 14708-1:2014

    Current The latest, up-to-date edition.

    IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  08-10-2014

    Publisher:  Association for the Advancement of Medical Instrumentation

    Add To Cart

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

    Glossary of equivalent standards
    Committee representation
    Background of ANSI/AAMI adoption of
    ISO 14708-1:2014
    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 B (informative) - Relationship between the fundamental
            principles in ISO/TR 14283:2004 and the clauses of this
            part of ISO 14708
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES.

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

    Committee ISO/TC 150
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current

    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
    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 45502-2-2 : 2008 COR 2009 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)
    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
    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
    ISO/TR 14283:2004 Implants for surgery Fundamental principles
    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
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    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
    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
    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)
    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
    AAMI TIR42 : 2010 EVALUATION OF PARTICULATES ASSOCIATED WITH VASCULAR MEDICAL DEVICES
    EN 45502-2-2 : 2008 COR 2009 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)
    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
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective