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SN EN 60601-2-41 : 2009 AMD 11 2011

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-41: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SURGICAL LUMINAIRES AND LUMINAIRES FOR DIAGNOSIS

Superseded date

19-11-2021

Published date

12-01-2013

INTRODUCTION
SECTION 1: GENERAL
1 Scope and object
2 Terminology and definitions
4 General requirements for tests
5 Classification
6 Identification, marking and documents
SECTION 2: ENVIRONMENTAL CONDITIONS
SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification
16 ENCLOSURES and PROTECTIVE COVERS
SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
22 Moving parts
24 Stability in NORMAL USE
25 Expelled parts
SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR
            EXCESSIVE RADIATION
34 Ultraviolet radiation
SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OF
            FLAMMABLE ANAESTHETIC MIXTURES
SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
            OTHER SAFETY HAZARDS
42 Excessive temperatures
44 Overflow, spillage, leakage, humidity, ingress of
      liquids, cleaning, sterilization and disinfection
49 Interruption of power supply
SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST
            HAZARDOUS OUTPUT
50 Accuracy of operating data
SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS;
            ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions
SECTION 10: CONSTRUCTIONAL REQUIREMENTS
55 ENCLOSURES and covers
56 Components and general assembly
57 MAINS PARTS, components and layout
59 Construction and layout
Figure 101 - Example of power supplies for SURGICAL LUMINAIRES
Figure 102 - STERILE HANDLE attachment and detachment tests
Figure 103 - Test for ease of motion
Figure 104 - Light distribution
Figure 106 - Measurement of LIGHT FIELD DIAMETER and diameter
             at 50% of CENTRAL ILLUMINANCE
Figure 108 - Illuminance measurement with two masks
Figure 109 - Illuminance measurement with four different
             positions of the two masks
Figure 111 - Detail of the inner surface of the tube (example)
Figure 113 - Illuminance measurement at the bottom of a
             cavity, with two masks
Figure 114 - Illuminance measurement at the bottom of a
             cavity, with four different positions of the
             two masks
Figure 115 - Measurement of DEPTH of ILLUMINATION
Annex L - References - Publications mentioned in this standard
Annex AA (informative) Guidance and rationale for particular
                       clauses and subclauses
Annex ZA
Annex ZB

The summary of the General Standard (IEC 60601-1) applies except as follows: Details the requirements to be applied to surgical luminaires and luminaires for diagnosis as defined in 2.101 and 2.105 (referred to as equipment). Does not apply to headlights; laparoscopes; endoscopes and their light sources; luminaires used dentistry, general purposes or luminaires of an emergency lighting. The main object is to establish particular requirements for the safety of surgical luminaires and luminaires for diagnosis.

DocumentType
Standard
PublisherName
Swiss Standards
Status
Superseded
SupersededBy

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