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    I.S. EN 60601-1-1:2001

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS

    Available format(s):  Hardcopy, PDF

    Superseded date:  15-11-2006

    Language(s):  English

    Published date:  01-01-2001

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    FOREWORD
    SECTION ONE - GENERAL
    1 Scope and object
    2 Terminology and definitions
    3 General requirements
    6 Identification, marking and documents
    SECTION TWO - ENVIRONMENTAL CONDITIONS
    10 Environmental conditions
    SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
    16 ENCLOSURES and PROTECTIVE COVERS
    17 Separation
    19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
    SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
    22 Moving parts
    SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
                   EXCESSIVE RADIATION
    SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
                  ANAESTHETIC MIXTURES
    SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
                    OTHER SAFETY HAZARDS
    44 Overflow, spillage, leakage, humidity, ingress of liquids,
       cleaning, sterilization, disinfection and compatibility
    49 Interruption of the power supply
    SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST
                    HAZARDOUS OUTPUT
    SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS;
                   ENVIRONMENTAL TESTS
    52 Abnormal operation and fault conditions
    SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
    56 Components and general assembly
    57 MAINS PARTS, components and layout
    58 Protective earthing - Terminals and connections
    59 Construction and layout
    Annex AAA (informative) General guidance and rationale
    Annex BBB (informative) Examples of combinations of MEDICAL
              ELECTRICAL EQUIPMENT and non-medical electrical equipment
    Annex CCC (normative) Normative references
    Annex DDD (informative) Bibliography
    Annex EEE (normative) Requirements for MULTIPLE PORTABLE
              SOCKET-OUTLETS
    Annex FFF (informative) Examples of application of MULTIPLE PORTABLE
              SOCKET-OUTLETS
    Annex ZA (normative) Normative references to international
             publications with their corresponding European publications
    Annex ZB (informative) Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the safety requirements necessary to provide protection for the PATIENT, the OPERATOR and surroundings.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By

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

    EN 60825-1:2014/AC:2017-06 SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS (IEC 60825-1:2014)
    EN 60065:2014/AC:2017-01 AUDIO, VIDEO AND SIMILAR ELECTRONIC APPARATUS - SAFETY REQUIREMENTS (IEC 60065:2014/COR2:2016)
    IEC 60950:1999 Safety of information technology equipment
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60884-1:2002+AMD1:2006+AMD2:2013 CSV Plugs and socket-outlets for household and similar purposes - Part1: General requirements
    ISO 8359:1996 Oxygen concentrators for medical use Safety requirements
    EN 60950:2000/corrigendum:2002 SAFETY OF INFORMATION TECHNOLOGY EQUIPMENT
    ISO 7767:1997 Oxygen monitors for monitoring patient breathing mixtures — Safety requirements
    IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
    ISO 9918:1993 Capnometers for use with humans Requirements
    ISO 10079-1:2015 Medical suction equipment Part 1: Electrically powered suction equipment
    ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    IEC 60989:1991 Separating transformers, autotransformers, variable transformersand reactors.
    EN 60335-1:2012/A13:2017 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 1: GENERAL REQUIREMENTS (IEC 60335-1:2010, MODIFIED)
    EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    EN 60601-1-4:1996/A1:1999 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
    EN 60529:1991/AC:2016-12 DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015)
    EN ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
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