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  • 11/30193150 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 60601-1:2006 AMD.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE

    Available format(s):  Hardcopy, PDF

    Superseded date:  29-02-2012

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    FOREWORD
    INTRODUCTION
    1 Scope, object and related standards
    2 Normative references
    3 Terminology and definitions
    4 General requirements
    5 General requirements for testing ME EQUIPMENT
    7 ME EQUIPMENT identification, marking and documents
    8 Protection against electrical HAZARDS from ME EQUIPMENT
    9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT
       and ME SYSTEMS
    10 Protection against unwanted and excessive radiation HAZARDS
    11 Protection against excessive temperatures and other HAZARDS
    12 Accuracy of controls and instruments and protection against
       hazardous outputs
    13 HAZARDOUS SITUATIONS and fault conditions
    14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
    15 Construction of ME EQUIPMENT
    16 ME SYSTEMS
    Annex A (informative) - General guidance and rationale
    Annex B (informative) - Sequence of testing
    Annex C (informative) - Guide to marking and labelling
            requirements for ME EQUIPMENT and ME SYSTEMS
    Annex D (informative) - Symbols on marking
    Annex G (normative) - Protection against HAZARDS of ignition of
            flammable anaesthetic mixtures
    Annex H (informative) - PEMS structure, PEMS DEVELOPMENT
            LIFE-CYCLE and documentation
    Annex J (informative) - Survey of insulation paths
    Annex L (normative) - Insulated winding wires for use without
            interleaved insulation
    Annex M (normative) - Reduction of pollution degrees
    Annex N (Informative) - Routine testing
    Bibliography
    INDEX OF ABBREVIATIONS AND ACRONYMS

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

    Comment Closes On
    Committee CH/62/1
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
    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 60245-1:2003+AMD1:2007 CSV Rubber insulated cables - Rated voltages up to and including 450/750 V - Part 1: General requirements
    ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
    IEC TR 62354:2014 General testing procedures for medical electrical equipment
    ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
    IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
    IEC 60601-2-22:2007+AMD1:2012 CSV Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
    IEC 60851-5:2008+AMD1:2011 CSV Winding wires - Test methods - Part 5: Electrical properties
    IEC 60227-1:2007 Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V - Part 1: General requirements
    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 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    IEC 61058-1:2016 Switches for appliances - Part 1: General requirements
    IEC 60851-3:2009+AMD1:2013 CSV Winding wires - Test methods - Part 3: Mechanical properties
    ISO 80000-1:2009 Quantities and units — Part 1: General
    ISO 13857:2008 Safety of machinery Safety distances to prevent hazard zones being reached by upper and lower limbs
    IEC 62471:2006 Photobiological safety of lamps and lamp systems
    IEC 62133 : 2.0EN+(REDLINE+VERSION) SECONDARY CELLS AND BATTERIES CONTAINING ALKALINE OR OTHER NON-ACID ELECTROLYTES - SAFETY REQUIREMENTS FOR PORTABLE SEALED SECONDARY CELLS, AND FOR BATTERIES MADE FROM THEM, FOR USE IN PORTABLE APPLICATIONS
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    IEC 60695-1-10:2016 Fire hazard testing - Part 1-10: Guidance for assessing the fire hazard of electrotechnical products - General guidelines
    IEC 60664-1:2007 Insulation coordination for equipment within low-voltage systems - Part 1: Principles, requirements and tests
    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 60730-1:2013+AMD1:2015 CSV Automatic electrical controls - Part 1: General requirements
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