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
Hardcopy , PDF
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
|
Standards | Relationship |
DIN EN 60601-2-50 : 2017 | Identical |
I.S. EN 60601-2-50:2009 | Identical |
BS EN 60601-2-50 : 2009 | Identical |
NF EN 60601-2-50 : 2009 AMD 1 2017 | Identical |
EN 60601-2-50:2009/A1:2016 | Identical |
IEC 60601-2-50:2009+AMD1:2016 CSV | Identical |
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