• PD IEC/TR 60601-4-3:2015

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    MEDICAL ELECTRICAL EQUIPMENT - PART 4-3: GUIDANCE AND INTERPRETATION - CONSIDERATIONS OF UNADDRESSED SAFETY ASPECTS IN THE THIRD EDITION OF IEC 60601-1 AND PROPOSALS FOR NEW REQUIREMENTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  04-01-2019

    Language(s):  English

    Published date:  01-01-2015

    Publisher:  British Standards Institution

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

    FOREWORD
    INTRODUCTION
    1 Scope and object
    2 Normative references
    3 Recommendations
    Annex A (informative) - Overview of the recommendations
            developed by IEC/SC 62A/WG 14
    Bibliography

    Abstract - (Show below) - (Hide below)

    Includes a series of recommendations developed by an expert working group of IEC subcommittee 62A in response to questions of interpretation of the third edition of IEC 60601-1.

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

    Committee CH/62/1
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

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    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 23529:2016 Rubber General procedures for preparing and conditioning test pieces for physical test methods
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    ISO 9614-1:1993 Acoustics — Determination of sound power levels of noise sources using sound intensity — Part 1: Measurement at discrete points
    ISO 13732-1:2006 Ergonomics of the thermal environment — Methods for the assessment of human responses to contact with surfaces — Part 1: Hot surfaces
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    IEC 60601-2-46 : 3.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-46: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OPERATING TABLES
    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
    IEC 60085:2007 Electrical insulation - Thermal evaluation and designation
    IEC 60601-2-28:2017 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
    IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
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    IEC 60601-2-28 : 3.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
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    IEC 60695-11-10:2013 Fire hazard testing - Part 11-10: Test flames - 50 W horizontal and vertical flame test methods
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    ISO 2878:2017 Rubber, vulcanized or thermoplastic Antistatic and conductive products Determination of electrical resistance
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    IEC 60252-1:2010+AMD1:2013 CSV AC motor capacitors - Part 1: General - Performance, testing andrating - Safety requirements - Guidance for installation and operation
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    ISO 5349-1:2001 Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General requirements
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    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
    IEC TR 62296:2009 Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
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    IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
    IEC 60730-1:2013+AMD1:2015 CSV Automatic electrical controls - Part 1: General requirements
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