• UNE EN 60601-2-50 : 2010

    Current The latest, up-to-date edition.

    MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT

    Available format(s):  Hardcopy, PDF

    Language(s): 

    Published date:  01-01-2010

    Publisher:  Asociacion Espanola de Normalizacion

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

    FOREWORD
    INTRODUCTION
    SECTION 1: GENERAL
    1 Scope and object
       1.1 Scope
       1.2 Object
       1.3 Particular Standards
       1.5 Collateral Standards
    2 Terminology and definitions
       2.1 EQUIPMENT parts, auxiliaries and ACCESSORIES
       2.12 Miscellaneous
    4 General requirements for tests
       4.6 Other conditions
    5 Classification
    6 Identification, marking and documents
       6.1 Marking on the outside of EQUIPMENT or
              EQUIPMENT parts
       6.2 Marking on the inside of EQUIPMENT or EQUIPMENT
              parts
       6.8 ACCOMPANYING DOCUMENTS
    SECTION 2: ENVIRONMENTAL CONDITIONS
    SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
    SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
    21 Mechanical strength
    24 Stability in NORMAL USE
    25 Expelled parts
    26 Vibration and noise
    SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED OR
                  EXCESSIVE RADIATION
    32 Light radiation (including lasers)
    33 Infrared radiation
    34 Ultraviolet radiation
    36 ELECTROMAGNETIC COMPATIBILITY
    SECTION SIX: PROTECTION AGAINST HAZARDS OF IGNITION OR
                 FLAMMABLE ANAESTHETIC MIXTURES
    SECTION SEVEN: PROTECTION AGAINST EXCESSIVE TEMPERATURES
                   AND OTHER SAFETY HAZARDS
    42 Excessive temperatures
    44 Fire protection
    SECTION EIGHT: ACCURACY OF OPERATING DATA AND PROTECTION
                   AGAINST HAZARDOUS OUTPUT
    50 Accuracy of operating data
       50.101 Measuring principles
       50.102 Spectral method
       50.103 Integral method
       50.104 Maximum TOTAL IRRADIANCE FOR BILIRUBIN E[bi max]
       50.105 Distribution
    51 Protection against hazardous output
    SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS;
                  ENVIRONMENTAL TESTS
    52 Abnormal operation and fault conditions
    SECTION TEN: CONSTRUCTIONAL REQUIREMENTS
    55 ENCLOSURES and covers
    56 Components and general assembly
       56.8 Indicators
    Annex L References - Publications mentioned in this
            standard
    Annex AA (informative) Guidance and rationale for particular
             subclauses
    Annex ZA (normative) Normative references to international
             publications with their corresponding European
             publications
    Annex ZB (informative) Other international publications
             mentioned in this standard with the references of
             the relevant European publications
    Figures

    Abstract - (Show below) - (Hide below)

    Defines requirements applicable to INFANT PHOTOTHERAPY EQUIPMENT which by means of visible radiation serve to reduce bilirubin in the body of infants suffering from icterus in the first months of life. Specifies tests for demonstrating compliance with these requirements.

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    Committee CTN 209
    Document Type Standard
    Product Note NEW CHILD IS ADDED AS AMD 1 2016
    Publisher Asociacion Espanola de Normalizacion
    Status Current
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