SN EN 60601-2-41 : 2009 AMD 11 2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
11-19-2021
01-12-2013
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
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