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BS EN IEC 60601-2-41:2021:2022 Edition

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Medical electrical equipment – Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

Published By Publication Date Number of Pages
BSI 2022 66
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IEC 60601-2-41:2021 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. This particular standard does not apply to – headlights; – endoscopes, laparoscopes and their light sources, which are covered by IEC 60601-2-18; – luminaires used in dentistry, which are covered by ISO 9680; – luminaires for general purposes, which are covered by IEC 60598-2-1 and IEC 60598-2-4; – luminaires dedicated to therapeutic purposes; – special purpose lights with different conditions of use such as light sources intended solely for decontamination of air and surfaces, UV lights for dermatological diagnosis, slit lamps for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems; – lights connected to surgical instruments, such as luminous retractors; – luminaires for emergency lighting, which are covered by IEC 60598-2-22. SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS are medical devices and not general lighting equipment. IEC 60601-2-41:2021 cancels and replaces the second edition published in 2009 and Amendment 1:2013. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) revised the statement of essential performance; b) added exposure limits, test conditions, calculation methods and safety warnings related to photobiological hazards; c) removed the terms “MINOR SURGICAL LUMINAIRES” and “MAJOR SURGICAL LUMINAIRES”; d) added definitions of MAXIMUM ILLUMINANCE DISTANCE and REFERENCE DISTANCE and allowed MANUFACTURERS to measure some performance characteristics at the REFERENCE DISTANCE that they specify; e) replaced the region of acceptable chromaticity in (x,y) colour space with a requirement for Du,v; f) added a requirement for acceptable drift of the lighthead when attached to the suspension system; g) added a requirement for fluid ingress protection; h) revised Table 201.101 of IEC 60601-2-41:2009 and IEC 60601-2-41:2009/AMD1:2013 and moved it to Annex BB; i) specified a new device for measuring SHADOW DILUTION in a simulated cavity; j) specified test conditions for luminaires equipped with distance sensors.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
5 Annex ZA (normative) Normative references to international publications with their corresponding European publications
7 English
CONTENTS
9 FOREWORD
12 INTRODUCTION
13 201.1 Scope, object and related standards
15 201.2 Normative references
201.3 Terms and definitions
16 Figures
Figure 201.101 – Examples of providing power to a surgical luminaire
19 Figure 201.102 – Examples of different distance and illuminance terms
20 201.4 General requirements
201.5 General requirements for testing me equipment
21 201.6 Classification of me equipment and me systems
22 201.7 Me equipment identification, marking and documents
24 201.8 Protection against electrical hazards from me equipment
201.9 Protection against mechanical hazards of me equipment and me systems
25 Figure 201.103 – Detachable handle attachment and detachment tests
27 Figure 201.104 – Test for ease of motion
28 201.10 * Protection against unwanted and excessive radiation hazards
30 Figure 201.105 – Light distribution
31 Figure 201.106 – Central illuminance measurement
Figure 201.107 – Measurements for determining light field diameters d10 and d50
32 Figure 201.108 – Illuminance measurement with one mask
33 Figure 201.109 – Illuminance measurement with two masks
34 Figure 201.110 – Illuminance measurement with four different positions of two masks
35 Figure 201.111 – Simulated cavity for illuminance measurements
Figure 201.112 – Illuminance measurement at the bottomof a simulated cavity, with one mask
36 Figure 201.113 – Illuminance measurement at the bottomof a simulated cavity, with two masks
37 Figure 201.114 – Illuminance measurement at the bottom of a simulated cavity, with four different positions of two masks
38 Figure 201.115 – Measurement of depth of illumination
43 201.11 Protection against excessive temperatures and other hazards
44 Figure 201.116 – Caution symbol for hot surface
Tables
Table 23 – Allowable maximum temperatures for me equipment partsthat are likely to be touched
45 201.12 Accuracy of controls and instruments and protection against hazardous outputs
46 201.13 hazardous situations and fault conditions for me equipment
201.15 Construction of me equipment
47 201.17 Electromagnetic compatibility of me equipment and me systems
48 Annexes
49 Annex AA (informative)Particular guidance and rationale
50 Table AA.1 – Summary of photobiological hazards and exposure limits
55 Annex BB (informative)Requirements for surgical luminaires and luminaires for diagnosis
Table BB.1 – Summary of requirements for surgical luminairesand luminaires for diagnosis
57 Annex CC (informative)Technical information for conducting tests
59 Figure CC.1 – Location of the illuminance meter and mask on the luminaire
60 Figure CC.2 – Movement of the illuminance meter and mask on the luminaire
Figure CC.3 – Location of the spectrometer and mask on the luminaire
61 Figure CC.4 – Test conditions for measuring illuminance at 500 mm
Figure CC.5 – Test method for maintaining the measurement distance
63 Bibliography
64 Index of defined terms used in this particular standard
BS EN IEC 60601-2-41:2021
$198.66