• CEI EN 60601-1-1 : 2003

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  13-06-2020

    Language(s):  English - Italian

    Published date:  01-01-2003

    Publisher:  Comitato Elettrotecnico Italiano

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

    SECTION 1 - GENERAL
    1 SCOPE AND OBJECT
    2 TERMINOLOGY AND DEFINITIONS
    3 GENERAL REQUIREMENTS
    6 IDENTIFICATION, MARKING AND
       DOCUMENTS
    SECTION 2 - ENVIRONMENTAL CONDITIONS
    10 ENVIRONMENTAL CONDITIONS
    SECTION 3 - PROTECTION AGAINST
                ELECTRIC SHOCK HAZARDS
    16 ENCLOSURES AND PROTECTIVE
       COVERS
    17 SEPARATION
    19 CONTINUOUS LEAKAGE CURRENTS
       AND PATIENT AUXILIARY CURRENTS
    SECTION 4 - PROTECTION AGAINST
                MECHANICAL HAZARDS
    22 MOVING PARTS
    SECTION 5 - PROTECTION AGAINST
                HAZARDS FROM UNWANTED
                OR EXCESSIVE RADIATION
    SECTION 6 - PROTECTION AGAINST
                HAZARDS OF IGNITION OF
                FLAMMABLE ANAESTHETIC
                MIXTURES
    SECTION 7 - 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 8 - ACCURACY OF OPERATING
                DATA AND PROTECTION
                AGAINST HAZARDOUS OUTPUT
    SECTION 9 - ABNORMAL OPERATION AND
                FAULT CONDITIONS; ENVIRONMENTAL
                TESTS
    52 ABNORMAL OPERATION AND FAULT
       CONDITIONS
    SECTION 10 - CONSTRUCTIONAL
                 REQUIREMENTS
    56 COMPONENTS AND GENERAL
       ASSEMBLY
    57 MAINS PARTS, COMPONENTS
       AND LAYOUT
    58 PROTECTIVE EARTHING - TERMINALS
       AND CONNECTION
    59 CONSTRUCTION AND LAYOUT
    ANNEX AAA - GENERAL GUIDANCE
                AND RATIONALE
    ANNEX BBB - EXAMPLES OF
                COMBINATIONS OF MEDICAL
                ELECTRICAL EQUIPMENT AND
                NON-MEDICAL ELECTRICAL
                EQUIPMENT
    ANNEX ZA (normative) - Normative
             references to international
             publications with their
             corresponding European
             publications
    Bibliography
    ANNEX EEE - REQUIREMENTS FOR MULTIPLE
                PORTABLE SOCKET-OUTLETS
    ANNEX FFF - EXAMPLES OF APPLICATION
                OF MULTIPLE PORTABLE
                SOCKET-OUTLETS

    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)

    Committee CT 62
    Development Note Classificazione CEI 62-51 (09/2001)
    Document Type Standard
    Publisher Comitato Elettrotecnico Italiano
    Status Withdrawn

    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
    CEI 76-2 : 1ED 1989 APPARECCHI LASER - SICUREZZA DALLE RADIAZIONI, CLASSIFICAZIONE DEI MATERIALI E PRESCRIZIONI
    ISO 9918:1993 Capnometers for use with humans Requirements
    ISO 10079-1:2015 Medical suction equipment Part 1: Electrically powered suction equipment
    CEI 96-1 : 1ED 1998
    ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
    CEI 23-50 : 2007 PLUGS AND SOCKET-OUTLETS FOR HOUSEHOLD AND SIMILAR PURPOSES GENERAL REQUIREMENTS
    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.
    CEI 70-1 : 1980 COR 1993
    EN 60335-1:2012/A13:2017 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 1: GENERAL REQUIREMENTS (IEC 60335-1:2010, MODIFIED)
    CEI 62-5 : 1ED 1980
    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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