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UNE EN 60601-2-50 : 2010

Current
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

Published date

01-01-2010

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

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.

Committee
CTN 209
DocumentType
Standard
Pages
57
ProductNote
NEW CHILD IS ADDED AS AMD 1 2016
PublisherName
Asociacion Espanola de Normalizacion
Status
Current

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