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  • EN 50637:2017

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    Medical electrical equipment - Particular requirements for the basic safety and essential performance of medical beds for children

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    Published date:  17-11-2017

    Publisher:  European Committee for Standards - Electrical

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

    European foreword
    Introduction
    201.1 Scope, object and related standards
    201.2 Normative references
    201.3 Terms and definitions
    201.4 General requirements
    201.5 General requirements for testing of ME EQUIPMENT
    201.6 Classification of ME EQUIPMENT and ME SYSTEMS
    201.7 ME EQUIPMENT identification, marking and documents
    201.8 Protection against electrical HAZARDS
           from ME EQUIPMENT
    201.9 Protection against MECHANICAL HAZARDS
           of ME EQUIPMENT and ME SYSTEMS
    201.10 Protection against unwanted and
           excessive radiation HAZARDS
    201.11 Protection against excessive
           temperatures and other HAZARDS
    201.12 Accuracy of controls and instruments
           and protection against hazardous outputs
    201.13 HAZARDOUS SITUATIONS and fault conditions
    201.14 Programmable electrical medical
           systems (PEMS)
    201.15 Construction of ME EQUIPMENT
    201.16 ME SYSTEMS
    201.17 Electromagnetic compatibility of ME
           EQUIPMENT and ME SYSTEMS
    Annex AA (normative) - Particular guidance and rationale
    Annex BB (normative) - Design requirements and
             recommendations for MEDICAL BED
    Annex CC (informative) - Particular guidance for
             assessing risk of entrapment in v-shaped
             openings
    Bibliography
    Index of defined terms used in this particular standard

    Abstract - (Show below) - (Hide below)

    201.1Scope, object and related standardsClause 1 of EN 60601-1:2006, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, applies, except as follows:201.1.1* ScopeReplacement:This Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.218, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for ADULTS in 201.3.201).This standard applies to medical beds with nonadjustable and electrical / mechanical adjustable functions.This Standard applies to MEDICAL BEDS with an internal length of up to 180 cm suitable to a body length of 155 cm.NOTE 1The limitation of 180 cm is in order to minimize the foreseeable misuse, of a parent sharing the bed with the child or that the bed will be used by an ADULT.If a manufacturer wishes to make a bed that can be used by both a child and an ADULT, e.g. length of 180 cm or more, then it will fulfil both EN 60601-2-52 and this particular standard.This Standard does not apply to MEDICAL BEDS intended for ADULTS as defined in 201.3.201 (covered by EN 60601-2-52). This Standard does not apply to :-incubators covered by EN 60601-2-19 ;-beds for children, covered by EN 716-1 and EN 716-2 ;-cribs and cradles covered by EN 1130 (all parts) ;-bunk beds and high beds, covered by EN 747-1 and 747-2.If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BEDS and to ME SYSTEMS, as relevant.HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of EN 60601-1:2006.NOTE 2See also 4.2 of EN 60601-1:2006.NOTE 3Body length is measured from crown to sole.

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

    Committee CLC/TC 62
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Current

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

    EN 50525-2-21:2011/AC:2013 ELECTRIC CABLES - LOW VOLTAGE ENERGY CABLES OF RATED VOLTAGES UP TO AND INCLUDING 450/750 V (U[0]/U) - PART 2-21: CABLES FOR GENERAL APPLICATIONS - FLEXIBLE CABLES WITH CROSSLINKED ELASTOMERIC INSULATION
    IEC 60245-1:2003+AMD1:2007 CSV Rubber insulated cables - Rated voltages up to and including 450/750 V - Part 1: General requirements
    DIN 32623:2009-11 Hospital children's cots made from metal and plastic - Safety requirements and testing
    EN ISO 9999:2016 (edition 5) Assistive products for persons with disability - Classification and terminology (ISO 9999:2016)
    EN 60601-1-3 : 2008 AMD 11 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008/A1:2013)
    ISO 9614-1:1993 Acoustics Determination of sound power levels of noise sources using sound intensity Part 1: Measurement at discrete points
    EN 716-2:2017 Furniture - Children's cots and folding cots for domestic use - Part 2: Test methods
    EN 1021-1:2014 FURNITURE - ASSESSMENT OF THE IGNITABILITY OF UPHOLSTERED FURNITURE - PART 1: IGNITION SOURCE SMOULDERING CIGARETTE
    EN 60601-2-19:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS (IEC 60601-2-19:2009/A1:2016)
    EN 71-2:2011+A1:2014 SAFETY OF TOYS - PART 2: FLAMMABILITY
    IEC 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
    IEC 60227-1:2007 Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V - Part 1: General requirements
    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
    EN 716-1:2017 FURNITURE - CHILDREN'S COTS AND FOLDING COTS FOR DOMESTIC USE - PART 1: SAFETY REQUIREMENTS
    EN 60601-1-2:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS (IEC 60601-1-2:2014)
    EN 13451-1:2011+A1:2016 SWIMMING POOL EQUIPMENT - PART 1: GENERAL SAFETY REQUIREMENTS AND TEST METHODS
    IEC 60601-2-52:2009+AMD1:2015 CSV Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
    IEC 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
    EN 60601-2-52:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-52: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS
    ISO 9999:2016 Assistive products for persons with disability Classification and terminology
    EN ISO 9614-1 : 2009 ACOUSTICS - DETERMINATION OF SOUND POWER LEVELS OF NOISE SOURCES USING SOUND INTENSITY - PART 1: MEASUREMENT AT DISCRETE POINTS
    EN 1021-2:2014 FURNITURE - ASSESSMENT OF THE IGNITABILITY OF UPHOLSTERED FURNITURE - PART 2: IGNITION SOURCE MATCH FLAME EQUIVALENT
    EN 60068-2-31:2008 ENVIRONMENTAL TESTING - PART 2-31: TESTS - TEST EC: ROUGH HANDLING SHOCKS, PRIMARILY FOR EQUIPMENT-TYPE SPECIMENS
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