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 \u2013 headlights; \u2013 endoscopes, laparoscopes and their light sources, which are covered by IEC 60601-2-18; \u2013 luminaires used in dentistry, which are covered by ISO 9680; \u2013 luminaires for general purposes, which are covered by IEC 60598-2-1 and IEC 60598-2-4; \u2013 luminaires dedicated to therapeutic purposes; \u2013 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; \u2013 lights connected to surgical instruments, such as luminous retractors; \u2013 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 \u201cMINOR SURGICAL LUMINAIRES\u201d and \u201cMAJOR SURGICAL LUMINAIRES\u201d; 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.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | 30452788 <\/td>\n<\/tr>\n | ||||||
| 103<\/td>\n | A-30373840 <\/td>\n<\/tr>\n | ||||||
| 104<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 106<\/td>\n | European foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
| 107<\/td>\n | Annex ZA (normative) Normative references to international publications with their corresponding European publications <\/td>\n<\/tr>\n | ||||||
| 109<\/td>\n | English CONTENTS <\/td>\n<\/tr>\n | ||||||
| 111<\/td>\n | FOREWORD <\/td>\n<\/tr>\n | ||||||
| 114<\/td>\n | INTRODUCTION <\/td>\n<\/tr>\n | ||||||
| 115<\/td>\n | 201.1 Scope, object and related standards <\/td>\n<\/tr>\n | ||||||
| 117<\/td>\n | 201.2 Normative references 201.3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 118<\/td>\n | Figures Figure 201.101 \u2013 Examples of providing power to a surgical luminaire <\/td>\n<\/tr>\n | ||||||
| 121<\/td>\n | Figure 201.102 \u2013 Examples of different distance and illuminance terms <\/td>\n<\/tr>\n | ||||||
| 122<\/td>\n | 201.4 General requirements 201.5 General requirements for testing me equipment <\/td>\n<\/tr>\n | ||||||
| 123<\/td>\n | 201.6 Classification of me equipment and me systems <\/td>\n<\/tr>\n | ||||||
| 124<\/td>\n | 201.7 Me equipment identification, marking and documents <\/td>\n<\/tr>\n | ||||||
| 126<\/td>\n | 201.8 Protection against electrical hazards from me equipment 201.9 Protection against mechanical hazards of me equipment and me systems <\/td>\n<\/tr>\n | ||||||
| 127<\/td>\n | Figure 201.103 \u2013 Detachable handle attachment and detachment tests <\/td>\n<\/tr>\n | ||||||
| 129<\/td>\n | Figure 201.104 \u2013 Test for ease of motion <\/td>\n<\/tr>\n | ||||||
| 130<\/td>\n | 201.10 * Protection against unwanted and excessive radiation hazards <\/td>\n<\/tr>\n | ||||||
| 132<\/td>\n | Figure 201.105 \u2013 Light distribution <\/td>\n<\/tr>\n | ||||||
| 133<\/td>\n | Figure 201.106 \u2013 Central illuminance measurement Figure 201.107 \u2013 Measurements for determining light field diameters d10 and d50 <\/td>\n<\/tr>\n | ||||||
| 134<\/td>\n | Figure 201.108 \u2013 Illuminance measurement with one mask <\/td>\n<\/tr>\n | ||||||
| 135<\/td>\n | Figure 201.109 \u2013 Illuminance measurement with two masks <\/td>\n<\/tr>\n | ||||||
| 136<\/td>\n | Figure 201.110 \u2013 Illuminance measurement with four different positions of two masks <\/td>\n<\/tr>\n | ||||||
| 137<\/td>\n | Figure 201.111 \u2013 Simulated cavity for illuminance measurements Figure 201.112 \u2013 Illuminance measurement at the bottomof a simulated cavity, with one mask <\/td>\n<\/tr>\n | ||||||
| 138<\/td>\n | Figure 201.113 \u2013 Illuminance measurement at the bottomof a simulated cavity, with two masks <\/td>\n<\/tr>\n | ||||||
| 139<\/td>\n | Figure 201.114 \u2013 Illuminance measurement at the bottom of a simulated cavity, with four different positions of two masks <\/td>\n<\/tr>\n | ||||||
| 140<\/td>\n | Figure 201.115 \u2013 Measurement of depth of illumination <\/td>\n<\/tr>\n | ||||||
| 145<\/td>\n | 201.11 Protection against excessive temperatures and other hazards <\/td>\n<\/tr>\n | ||||||
| 146<\/td>\n | Figure 201.116 \u2013 Caution symbol for hot surface Tables Table 23 \u2013 Allowable maximum temperatures for me equipment partsthat are likely to be touched <\/td>\n<\/tr>\n | ||||||
| 147<\/td>\n | 201.12 Accuracy of controls and instruments and protection against hazardous outputs <\/td>\n<\/tr>\n | ||||||
| 148<\/td>\n | 201.13 hazardous situations and fault conditions for me equipment 201.15 Construction of me equipment <\/td>\n<\/tr>\n | ||||||
| 149<\/td>\n | 201.17 Electromagnetic compatibility of me equipment and me systems <\/td>\n<\/tr>\n | ||||||
| 150<\/td>\n | Annexes <\/td>\n<\/tr>\n | ||||||
| 151<\/td>\n | Annex AA (informative)Particular guidance and rationale <\/td>\n<\/tr>\n | ||||||
| 152<\/td>\n | Table AA.1 \u2013 Summary of photobiological hazards and exposure limits <\/td>\n<\/tr>\n | ||||||
| 157<\/td>\n | Annex BB (informative)Requirements for surgical luminaires and luminaires for diagnosis Table BB.1 \u2013 Summary of requirements for surgical luminairesand luminaires for diagnosis <\/td>\n<\/tr>\n | ||||||
| 159<\/td>\n | Annex CC (informative)Technical information for conducting tests <\/td>\n<\/tr>\n | ||||||
| 161<\/td>\n | Figure CC.1 \u2013 Location of the illuminance meter and mask on the luminaire <\/td>\n<\/tr>\n | ||||||
| 162<\/td>\n | Figure CC.2 \u2013 Movement of the illuminance meter and mask on the luminaire Figure CC.3 \u2013 Location of the spectrometer and mask on the luminaire <\/td>\n<\/tr>\n | ||||||
| 163<\/td>\n | Figure CC.4 \u2013 Test conditions for measuring illuminance at 500 mm Figure CC.5 \u2013 Test method for maintaining the measurement distance <\/td>\n<\/tr>\n | ||||||
| 165<\/td>\n | Bibliography <\/td>\n<\/tr>\n | ||||||
| 166<\/td>\n | Index of defined terms used in this particular standard <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Tracked Changes. Medical electrical equipment – Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis<\/b><\/p>\n |