Bsi bs en 60601 2 41 2009 + a1 2015

60601-2-41:2009+A1:2015 BSBS ENEN 60601-2-41:2009+A11:2011 BSI Standards Publication Medical electrical equipment Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis BS EN 60601-2-41:2009+A1:2015 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN 60601-2-41:2009+A1:2015 It is identical to IEC 60601-2-41:2009, incorporating amendment 1:2013 It supersedes BS EN 60601-2-41:2009+A11:2011, which will be withdrawn on 14 April 2018 The start and finish of text introduced or altered by amendment is indicated in the text by tags Tags indicating changes to IEC text carry the number of the IEC amendment For example, text altered by IEC amendment is indicated by  The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/4, Electromedical equipment A list of organizations represented on this subcommittee can be obtained on request to its secretary This publication does not purport to include all the necessary provisions of a contract Users are responsible for its correct application © The British Standards Institution 2015 Published by BSI Standards Limited 2015 ISBN 978 580 75598 ICS 11.040.20; 11.040.55; 11.040.99 Compliance with a British Standard cannot confer immunity from legal obligations This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2010 Amendments/corrigenda issued since publication Date Text affected 31 March 2012 Implementation of CENELEC amendment A11:2011: Annex ZZ replaced 31 July 2015 Implementation of IEC amendment 1:2013 with CENELEC endorsement A1:2015 EUROPEAN STANDARD EN 60601-2-41:2009+A1 60601-2-41:2009+A11 NORME EUROPÉENNE EUROPÄISCHE NORM October May 20152011 ICS 11.040.20; 11.040.55; 11.040.99 Supersedes EN 60601-2-41:2009 English version Medical electrical equipment Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis (IEC 60601-2-41:2009) Appareils électromédicaux Partie 2-41: Exigences particulières pour la sécurité de base et les performances essentielles des éclairages chirurgicaux et des éclairages de diagnostic (CEI 60601-2-41:2009) Medizinische elektrische Geräte Teil 2-41: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Operationsleuchten und Untersuchungsleuchten (IEC 60601-2-41:2009) This European Standard was approved by CENELEC on 2009-11-01 CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member This European Standard exists in three official versions (English, French, German) A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung Central Secretariat: Avenue Marnix 17, B - 1000 Brussels © 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members Ref No EN 60601-2-41:2009 E BS EN 60601-2-41:2009+A1:2015 EN (E) BS60601-2-41:2009+A1:2015 EN 60601-2-41:2009+A11:2011 EN 60601-2-41:2009+A11:2011 (E) –2– –2– Foreword The text of document 62D/773/FDIS, future edition of IEC 60601-2-41, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-41 on 2009-11-01 This European Standard supersedes EN 60601-2-41:2000 EN 60601-2-41:2000 was revised to be consistent with EN 60601-1:2006 The following dates were fixed: – latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2010-08-01 – latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2012-11-01 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive MDD (93/42/EEC) See Annex ZZ In this standard, the following print types are used: – Requirements and definitions: roman type – Test specifications: italic type – Informative material appearing outside of tables, such as notes, examples and references: in smaller type Normative text of tables is also in a smaller type – TERMS DEFINED IN CLAUSE OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS In referring to the structure of this standard, the term – “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g Clause includes subclauses 7.1, 7.2, etc.); – “subclause” means a numbered subdivision of a clause (e.g 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7) References to clauses within this standard are preceded by the term “Clause” followed by the clause number References to subclauses within this particular standard are by number only In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part For the purposes of this standard, the auxiliary verb: − “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; − “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; − “may” is used to describe a permissible way to achieve compliance with a requirement or test An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA –3– –3– BS EN 60601-2-41:2009+A1:2015 60601-2-41:2009+A1:2015 (E) BS ENEN 60601-2-41:2009+A11:2011 EN 60601-2-41:2009+A11:2011 (E) Annexes ZA and ZZ have been added by CENELEC Endorsement notice The text of the International Standard IEC 60601-2-41:2009 was approved by CENELEC as a European Standard without any modification In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60598-1 NOTE Harmonized as EN 60598-1:2008 (modified) IEC 60598-2-1 NOTE Harmonized as EN 60598-2-1:1989 (not modified) IEC 60598-2-4 NOTE Harmonized as EN 60598-2-4:1997 (not modified) IEC 60598-2-22 NOTE Harmonized as EN 60598-2-22:1998 (modified) IEC 60598-2-25 NOTE Harmonized as EN 60598-2-25:1994 (not modified) ISO 9680 NOTE Harmonized as EN ISO 9680:2007 (not modified) Foreword to amendment A11 This document (EN 60601-2-41:2009/A11:2011) has been prepared by CLC/TC 62 “Electrical equipment in medical practice” The following dates are fixed: • latest date by which this document has to be implemented at national level by publication of an identical national standard or by endorsement • latest date by which the national standards conflicting with this document have to be withdrawn (dop) 2012-10-01 (dow) 2014-10-01 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights EN EN 60601-2-41:2009/A1:2015 BS 60601-2-41:2009+A1:2015 EN 60601-2-41:2009+A1:2015 (E) –4– ForewordForeword to amendment A1 The text of document 62D/1081/FDIS, future IEC 60601-2-41:2009/A1, prepared by SC 62D "Electromedical equipment", of IEC/TC 62 "Electrical equipment in medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-41:2009/A1:2015 The following dates are fixed: • latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-01-14 • latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-04-14 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s) For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 60601-2-41:2009/A11:2011 Endorsement notice The text of the International Standard IEC 60601-2-41:2009/A1:2013 was approved by CENELEC as a European Standard without any modification In the Bibliography of EN 60601-2-41:2009, the following note has to be added for the standard indicated: IEC 60601-2-50 NOTE Harmonized as EN 60601-2-50:2009 (not modified) BS EN 60601-2-41:2009+A11:2011 EN 60601-2-41:2009+A11:2011 (E) –5– BS EN 60601-2-41:2009+A1:2015 EN 60601-2-41:2009+A1:2015 (E) –4– Annex ZA (normative) Normative references to international publications with their corresponding European publications The following referenced documents are indispensable for the application of this document For dated references, only the edition cited applies For undated references, the latest edition of the referenced document (including any amendments) applies NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies Annex ZA of EN 60601-1:2006 applies, except as follows: Year Title IEC 60417 database Graphical symbols for use on equipment - - IEC 60598-2-9 - 1) Luminaires Part 2: Particular requirements Section 9: Photo and film luminaires (nonprofessional) EN 60598-2-9 1989 ISO 11664-1 - 1) Colorimetry Part 1: CIE standard colorimetric observers - - CIE 13.3 - 1) Method of measuring and specifying colour rendering of light sources - - CIE 15 - 1) Colorimetry - - 1) Methods of characterizing illuminance meters and luminance meters: Performance, characteristics and specifications - Publication EN/HD Year Addition: CIE 69 1) 2) - Undated reference Valid edition at date of issue 2) BS EN 60601-2-41:2009+A1:2015 EN 60601-2-41:2009+A1:2015 (E) –6– –5– BS EN 60601-2-41:2009+A11:2011 EN 60601-2-41:2009+A11:2011 (E) Annex ZZ (informative) Coverage of Essential Requirements of EC Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC except as follows: – – – – Essential Requirement 6a Essential Requirement 7.4 Essential Requirement 7.5 paragraph & Essential Requirement 13.6 (q) Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard _ BS EN 60601-2-41:2009+A11:2011 EN 60601-2-41:2009+A11:2011 (E) –7– BS EN 60601-2-41:2009+A1:2015 EN 60601-2-41:2009+A1:2015 (E) –6– CONTENTS INTRODUCTION 89 201.1 Scope, object and related standards 10 201.2 11 Normative references 10 201.3 Terms and definitions 11 12 201.4 General requirements 14 16 201.5 15 General requirements for testing of ME EQUIPMENT 16 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 16 15 201.7 ME EQUIPMENT I dentification, 201.8 17 Protection against electrical HAZARDS from ME EQUIPMENT 18 201.9 17 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS 18 16 marking and documents 17 20 201.10 Protection against unwanted and excessive radiation HAZARDS 21 201.11 Protection against excessive temperatures and other HAZARDS 20 21 201.12 Accuracy of controls and instruments and protection against hazardous outputs 21 22 36 201.13 HAZARDOUS SITUATIONS and fault conditions 35 36 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS ( PEMS ) 35 36 201.15 Construction of ME EQUIPMENT 35 35 201.16 ME SYSTEMS 36 36 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 35 38 Annex AA (informative) Guidance and rationale for particular clauses and subclauses 37 41 Bibliography 40 Index of defined terms 41 42 Figure 201.101 – Example of power supplies for SURGICAL LUMINAIRES 113 Figure 201.102 – DETACHABLE HANDLE attachment and detachment tests 18 19 20 Figure 201.103 – Test for ease of motion 19 Figure 201.104 – Light distribution 225 Figure 201.105 – C ENTRAL ILLUMINANCE measurement 227 Figure 201.106 – Measurements of LIGHT FIELD DIAMETER and diameter at 50 % of 27 CENTRAL ILLUMINANCE Figure 201.107 – Illuminance measurement with one mask 228 Figure 201.108 – Illuminance measurement with two masks 27 28 Figure 201.109 – Illuminance measurement with four different positions of the two 29 masks 28 30 Figure 201.110 – Tube for illuminance measurement 29 Figure 201.111 – Detail of the inner surface of the tube (example) 230 31 Figure 201.112 – Illuminance measurement at the bottom of a cavity, with one mask 30 32 Figure 201.113 – Illuminance measurement at the bottom of a cavity, with two masks 31 Figure 201.114 – Illuminance measurement at the bottom of a cavity, with four different 33 positions of the two masks 32 Figure 201.115 – Measurement of DEPTH OF ILLUMINATION 334 40 Figure AA.1 – Changeover cycle to an emergency backup system 38 BS EN 60601-2-41:2009+A1:2015 EN 60601-2-41:2009+A1:2015 (E) –8– –7– BS EN 60601-2-41:2009+A11:2011 EN 60601-2-41:2009+A11:2011 (E) 15 Table 201.101 – Classification of SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS 14 16 Table 201.102 – Distributed ESSENTIAL PERFORMANCE requirements 15 Table 201.103 – Allowable maximum temperatures for ME EQUIPMENT parts that are 22 likely to be touched 21 BS EN 60601-2-41:2009+A1:2015 EN 60601-2-41:2009+A1:2015 (E) – 32 – BS EN 60601-2-41:2009+A11:2011 EN 60601-2-41:2009+A11:2011 (E) – 31 – ME EQUIPMENT 210 210 Tube (see Figure 201.110) = 260 600 = 000 Mask Photometer head Mask: matt black circular disk of 210 mm diameter IEC 1382/09 Dimensions in millimetres Figure 201.113 – Illuminance measurement at the bottom of a cavity, with two masks BS EN 60601-2-41:2009+A11:2011 EN 60601-2-41:2009+A11:2011 (E) – 33 – BS EN 60601-2-41:2009+A1:2015 EN 60601-2-41:2009+A1:2015 (E) – 32 – ME EQUIPMENT Mask Tube Position Position Position Position Mask: matt black circular disk of 210 mm diameter IEC 1383/09 Figure 201.114 – Illuminance measurement at the bottom of a cavity, with four different positions of the two masks i) DEPTH OF ILLUMINATION The ME EQUIPMENT is set at 000 mm (or the specified working distance) for measuring CENTRAL ILLUMINANCE From this position, the photometer head is moved above and below along a vertical line passing through the LIGHT FIELD CENTRE , until the illuminance reaches 60 % of the previous CENTRAL ILLUMINANCE The distance between the upper and lower measurements gives the DEPTH OF ILLUMINATION (see Figure 201.115) BS EN 60601-2-41:2009+A1:2015 EN 60601-2-41:2009+A1:2015 (E) – 34 – – 33 – BS EN 60601-2-41:2009+A11:2011 EN 60601-2-41:2009+A11:2011 (E) ME EQUIPMENT LIGHT FIELD CENTRE (LFC) L2 CENTRAL ILLUMINANCE L1 000 E1 = 60 % Ec E2 = 60 % Ec DEPHT OF ILLUMINATION = L1 + L2 IEC 1384/09 Dimensions in millimetres Figure 201.115 – Measurement of DEPTH OF ILLUMINATION 201.12.1.102.2 201.12.1.102.2.1 Spectral characteristics General requirements The emission spectrum of SURGICAL LUMINAIRES and SURGICAL LUMINAIRE SYSTEMS shall be appropriate for tissue differentiation For this purpose, the colour rendering index R a (see Annex L, CIE 13.3:1995) shall be between 85 and 100 and the colour temperature of the radiation emitted shall be within the range of 000 K and 700 K when the SURGICAL LUMINAIRE or the SURGICAL LUMINAIRE SYSTEM is set to produce a maximum illuminance in order to render exactly the slight colour differences of the operative field Compliance is checked by testing 201.12.1.102.2.2 Tests to be performed Tests are carried out in accordance with the requirements of CIE 13.3:1995 and CIE 15:2004 The chromaticity co-ordinates (x, y) (reference observer CIE 1931 — see CIE 15:2004 or ISO 11664-1) of the radiation emitted by the ME EQUIPMENT shall be within the field defined by the following co-ordinates of six points A, B, C, D, E and F A: x = 0,31 y = 0,375 B: x = 0,31 y = 0,307 C: x = 0,341 y = 0,307 BS EN 60601-2-41:2009+A11:2011 EN 60601-2-41:2009+A11:2011 (E) D: x = 0,42 y = 0,37 E: x = 0,445 y = 0,422 F: x = 0,38 y = 0,422 201.12.1.102.3 – 35 – BS EN 60601-2-41:2009+A1:2015 EN 60601-2-41:2009+A1:2015 (E) – 34 – *Temperature rise in the lighted surface 201.12.1.102.3.1 General requirements To prevent undesirable temperature rise in the operating field, the total irradiance should be minimized At a distance of 000 mm for one single light head, the total irradiance E e in the lighted area shall not exceed 000 W/m If the maximum total irradiance occurs at a distance other than 000 mm, the location and value of this irradiance shall be reported in the instructions for use See also 201.7.9.2.1 This requirement applies for both LUMINAIRES FOR DIAGNOSIS and SURGICAL LUMINAIRES For SURGICAL LUMINAIRES , the ratio of irradiance E e and illuminance E c shall not exceed mW/m lx In the case of SURGICAL LUMINAIRE SYSTEMS , it is possible to exceed an irradiance of 000 W/m² by overlapping the light fields of several luminaires Therefore, information shall be given in the instructions for use that there is a risk of too much heat in the operating field Compliance is checked by measurement of irradiance and illuminance according to 201.12.1.102.1.3 201.12.1.102.3.2 Tests to be performed The total irradiance E e is measured in a plane 000 mm below the lowest point of the light emitting surface of the ME EQUIPMENT , at the LIGHT FIELD CENTRE (or at a measurement distance specified by the MANUFACTURER if the specified working range does not include 000 mm) 201.12.1.102.4 Safety characteristics a) Stability of the light source The luminous flux emitted by the ME EQUIPMENT shall not vary by more than 20 % during use The colour temperature and colour rendering index shall be stable and comply with 201.12.1.102.2 Tests shall be performed at the RATED VOLTAGE of the ME EQUIPMENT with a h operating – h rest cycle, over a 10 day period Compliance is checked by measurement and comparing the CENTRAL ILLUMINANCE , colour temperature and colour rendering index before and after the 10 day test *b) Lamp failure The failure of a lamp shall be identifiable by the OPERATOR without opening the ME EQUIPMENT Compliance is checked by inspection and testing When a lamp fails, MAJOR SURGICAL LUMINAIRES or SURGICAL LUMINAIRE SYSTEMS shall restore the illumination in less than s The restored CENTRAL ILLUMINANCE shall not be less than 50 % of the previous CENTRAL ILLUMINANCE and shall not be less than 40 000 lx Compliance is checked by testing c) Maintenance of the ME EQUIPMENT without a TOOL During maintenance (e.g., replacement of a light source ), parts ensuring the safety of the ME EQUIPMENT in operation shall not need to be removed Otherwise, the ME EQUIPMENT BS EN 60601-2-41:2009+A1:2015 EN 60601-2-41:2009+A1:2015 (E) – 36 – – 35 – BS EN 60601-2-41:2009+A11:2011 EN 60601-2-41:2009+A11:2011 (E) shall be equipped with a safety device preventing power from being turned on In addition, safety information on the essential part shall be marked on the ME EQUIPMENT Lamp changing shall require a tool if it necessitates optical filter removal Compliance is checked by inspection and functional test d) Operating life of the light source The MANUFACTURER shall give information about the operating life of the light source in the instructions for use If the RISK MANAGEMENT PROCESS requires it, there shall be a device to inform the OPERATOR when replacement of the light source is due Compliance is checked by inspection 201.13 HAZARDOUS SITUATIONS and fault conditions Clause 13 of the general standard applies, except as follows: 201.13.1 Specific HAZARDOUS SITUATIONS Addition: 201.13.1.101 H AZARDOUS SITUATIONS for FAIL SAFE EQUIPMENT MAJOR SURGICAL LUMINAIRES and SURGICAL LUMINAIRE SYSTEMS shall be so designed that even in SINGLE FAULT CONDITION no SAFETY HAZARD exists and main functions (illumination, maneuverability) are preserved During SINGLE FAULT CONDITION and after s of any interruption, MAJOR SURGICAL LUMINAIRES and SURGICAL LUMINAIRE SYSTEMS shall provide CENTRAL ILLUMINANCE of not less than 40 000 lx 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS ( PEMS ) Clause 14 of the general standard applies 201.15 Construction of ME EQUIPMENT Clause 15 of the general standard applies, except as follows: 201.15.3 201.15.3.1 Mechanical strength General Addition: The test is not applied to the illuminating surface of ME EQUIPMENT 201.16 ME SYSTEMS Clause 16 of the general standard applies 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS Clause 17 of the general standard applies BS EN 60601-2-41:2009+A11:2011 EN 60601-2-41:2009+A11:2011 (E) – 37 – – 36 – Annexes The annexes of the general standard apply, except as follows: BS EN 60601-2-41:2009+A1:2015 EN 60601-2-41:2009+A1:2015 (E) to 201.7.9.2.1 shall indicate the values of BS EN 60601-2-41:2009+A1:2015 – remaining illuminance when the beam is obstructed by one mask, – 38 – EN 60601-2-41:2009+A1:2015 (E) BSmasks, EN 60601-2-41:2009+A11:2011 – remaining illuminance when the beam is obstructed by two EN 60601-2-41:2009+A11:2011 (E) – 37 – – remaining illuminance at the bottom of a standardized tube (inside), – remaining illuminance at the bottom of a standardized tube when the beam is obstructed by one mask, – remaining illuminance at the bottom(informative) of a standardized tube when the beam is obstructed by two masks Annex AA Guidance and rationale particular clauses and subclauses ILLUMINANCE without obstruction by All values of remaining illuminance arefor relative to CENTRAL masks or tube and are expressed as percentages 201.12.1.102.1.2 General conditions for tests This annex provides a concise rationale for the important requirements of this particular standard and is intended for those who are familiar with the subject of the standard but who Replace, the second insentence of the first An paragraph, the reference "4.5" offorthethe general have not inparticipated its development understanding of the to reasons main standard with "5.3" requirements is considered essential for the proper application of the standard Furthermore, as clinical practice and technology change, it is believed that a rationale for the present Add, after the will firstfacilitate paragraph, following new paragraph: requirements anythe revision of the standard necessitated by these developments EN 60601-2-41:2009+A11:2011 Measurements shouldS COPE be performed after the light has beenBS operated at highest intensity for Subclause 201.1.1 at least one hour EN 60601-2-41:2009+A11:2011 (E) – 37 – Headlights and lights connected to surgical instruments are excluded from the scope of this standard following Add, afterfor thethe existing fifthreasons: paragraph, the following new paragraph: SURGICAL LUMINAIRES (ergonomics, hygiene, – conditions of use are different from Annex those of AA All FAIL testsSAFE shall be performed without any additional user-initiated adjustments (such as (informative) conditions, etc.); re-focussing) – headlights are permanently connected to the OPERATOR and the PATIENT during the Guidance and rationale for particular clauses and subclauses surgical procedure They require special insulation conditions Annex AA – Guidance and rationale for particular clauses and subclauses UV lights, slit lamps and lights for microscopes used for surgery, along with lights for surgical navigation systems, are excluded from the scope of this standard for the following reasons: This annex 201.1.1 provides SaCOPE concise rationale for the important requirements of this particular Subclause standard and is for those from who those are familiar with the subject of (ergonomics, the standard hygiene, but who LUMINAIRES – conditions of intended use are different of SURGICAL Add, after theconditions, last paragraph, following new have not participated inetc.) its the development An text: understanding of the reasons for the main FAIL SAFE requirements is considered essential for the proper application of the standard Furthermore, as clinical practice andFAIL technology change,a ithigh is believed that for the present SAFE to produce Subclause 201.3.103 Surgical luminaires are intended illumination in atherationale visible range (400 nm – requirements will facilitate any revision of the standard necessitated by these developments 780 nm) They are not intended to produce invisible and potentially harmful UV radiation FAULT Single luminaires without anytooprotection against a SINGLE However, in order not to lose much of the visiblelight blueinterruption light output,under the cut-off filtering for CONDITION are not FAIL SAFE UV may allow some output in the longest wavelength range of the UVA close to the visible Subclause 201.1.1 S COPE blue boundary of 400 nm Headlights lights connected to surgical instruments are excluded from the scope of this SINGLE FAULT CONDITION : Examples ofand standard for the following reasons: If measured with a radiometer that produces a flat wavelength response, a maximum EQUIPMENT ; – breakage UV of wire inside the in the range from 300 nm – 400 nm therefore is unweighted irradiance of ME 10 W/m – conditions of use are different from those of SURGICAL LUMINAIRES (ergonomics, hygiene, allowed – failure of slip ring; FAIL SAFE conditions, etc.); – failure of a fuse; and the PATIENT during the – headlights are permanently connected to the OPERATOR Other IEC standards exist that also state maximum UV irradiance values An example is – failure of a lamp; surgical procedure They require special insulation conditions IEC 60601-2-50 that allows for a maximum effective UV irradiance of 0,1 mW/m This value is ordersofofinsulation; magnitude lower than the 10 W/m listed in IEC 60601-2-41 The difference lies – 5failure UV lights, slit lamps and lights for microscopes used for surgery, along with lights for surgical in the term effective irradiance An effective UV irradiance or UV dose value indicates that – failure in electronic navigation systems, aredevice; excluded from the scope of this standard for the following reasons: a spectral weighting function (like, e.g the ICNIRP combined action spectrum for skin and – lamp power supply cables detachment eyes) has been the actual as measured by a radiometer with a flat LUMINAIRES (ergonomics, hygiene, – conditions of applied use are to different from irradiance those of SURGICAL spectral response  SAFE conditions, etc.) For FAIL example, a SURGICAL LUMINAIRE SYSTEM consisting of two MINOR LUMINAIRES , moveable independently, with separate transformers, fuses, wiring and slip rings is FAIL SAFE if, in the Subclause 201.3.103 FAIL SAFE case of a SINGLE FAULT of any MINOR LUMINAIRE , the other MINOR LUMINAIRE provides a minimum of 40 000 without lx Single luminaires any protection against light interruption under a SINGLE FAULT are not FAIL SAFE Subclause 201.9.2.101 DETACHABLE HANDLE CONDITION Examples of SINGLE FAULT CONDITION : Correct use of DETACHABLE HANDLE (design guidelines for locking and unlocking mechanism) – breakage of wire inside the ME EQUIPMENT ; If a luminaire is equipped with a DETACHABLE HANDLE this is a hand gripping device located on – failure of slip ring; the luminaire and used to move the ME EQUIPMENT in order to adapt the lighted area according – need failure of a fuse; to – failure of a lamp; – failure of insulation; – failure in electronic device; Examples of SINGLE FAULT CONDITION : – – 39 – breakage of wire inside the ME EQUIPMENT ; – failure of slip ring; – failure of a fuse; – failure of a lamp; – failure of insulation; – failure in electronic device; – lamp power supply cables detachment BS EN 60601-2-41:2009+A1:2015 EN 60601-2-41:2009+A1:2015 (E) For example, a SURGICAL LUMINAIRE SYSTEM consisting of two MINOR LUMINAIRES , moveable independently, with separate transformers, fuses, wiring and slip rings is FAIL SAFE if, in the case of a SINGLE FAULT of any MINOR LUMINAIRE , the other MINOR LUMINAIRE provides a minimum of 40 000 lx Subclause 201.9.2.101 DETACHABLE HANDLE Correct use of DETACHABLE HANDLE (design guidelines for locking and unlocking mechanism) BS EN 60601-2-41:2009+A11:2011 If a luminaire is equipped with a DETACHABLE HANDLE this is a hand gripping device located on EN luminaire 60601-2-41:2009+A11:2011 (E)ME EQUIPMENT – 38 – in order to adapt the lighted area according the and used to move the to need The locking and unlocking mechanism of the device should be designed so that: – the OPERATOR can clearly check the correct fixation of the DETACHABLE HANDLE lighthead; on the – this mechanism does not compromise the sterile condition of the DETACHABLE HANDLE during use; – once positioned onto its support, the gripping area of the DETACHABLE HANDLE does not come in contact with the non-sterile lighthead The appropriate test procedure to measure the force for intentional detachment of the handle depends on the method by which the handle is released The test procedure therefore cannot be specified in this standard, and needs to be specified by the MANUFACTURER for each model Interruption of power supply/SUPPLY MAINS to ME EQUIPMENT Subclause 201.11.8 ln the event of interruption of the SUPPLY MAINS : – a change of the colour temperature and colour rendering index during emergency operation is acceptable; – the duration of such emergency lighting is defined in IEC 60364-7-710; – the battery or generator backup system is not necessarily part of the ME EQUIPMENT; – the changeover cycle to an emergency backup system showing the progressive restoration of illumination is described in Figure AA.1 Interruption of the SUPPLY MAINS Illuminance 100 % 95 % 50 % 0,5 s Time 5s 40 s IEC 1385/09 – the duration of such emergency lighting is defined in IEC 60364-7-710; – the battery or generator backup system is not necessarily part of the ME EQUIPMENT; BS EN 60601-2-41:2009+A1:2015 – 60601-2-41:2009+A1:2015 the changeover cycle to an – 40 – system showing the progressive restoration EN (E)emergency backup of illumination is described in Figure AA.1 Interruption of the SUPPLY MAINS Illuminance 100 % 95 % 50 % Time 0,5 s 5s 40 s IEC 1385/09 Figure AA.1 – Changeover cycle to an emergency backup system Subclause 201.12.1.102.3 Temperature rise in the lighted surface Total irradiance versus temperature rise: BS EN 60601-2-41:2009+A11:2011 EN 60601-2-41:2009+A11:2011 – 39 – The measurement of total irradiance is preferred to a measurement of temperature rise(E) because of the many variables that can affect temperature at the surgical site Subclause 201.12.1.102.4 b) Lamp failure Lamp failure is a SINGLE FAULT CONDITION and will occur by ageing of the lamp Even though not predictable, frequent failure occurrence makes it necessary to impose a more severe backup condition CENTRAL ILLUMINANCE An upper limit of a 160 000 lx is specified to limit undue eye fatigue Overlapping the light field of two or more SURGICAL LUMINARIES may exceed this upper limit and increase this risk of eye fatigue – 41 – BS EN 60601-2-41:2009+A11:2011 EN 60601-2-41:2009+A11:2011 (E) BS EN 60601-2-41:2009+A1:2015 EN 60601-2-41:2009+A1:2015 (E) – 40 – BS EN 60601-2-41:2009+A11:2011 EN 60601-2-41:2009+A11:2011 (E) Bibliography – 40 – The Bibliography of the general standard applies with the following exceptions: Bibliography Addition: The Bibliography of the general standard applies with the following exceptions: IEC 60598-1, Luminaires – Part 1: General requirements and tests Addition: IEC 60598-2-1, Luminaires – Part 2: Particular requirements Section One – Fixed general IEC 60598-1, Luminaires – Part 1: General requirements and tests purpose luminaires 60598-2-1, Luminaires –– Part – Fixed general IEC 60598-2-4, Part 2: 2: Particular Particular requirements requirements Section SectionOne 4: Portable purpose luminaires 60598-2-4, Luminaires 2: Particular 4: Portable general IEC 60598-2-22, Luminaires –– Part 2-22: Particularrequirements requirements Section – Luminaires for emergency purpose luminaires lighting 60598-2-22, Luminaires Particularrequirements requirements– –Section Luminaires for emergency IEC 60598-2-25, Luminaires –– Part Part 2-22: 2: Particular 25: Luminaires for lighting use in clinical areas of hospitals and health care buildings 60598-2-25, Medical Luminaires – Part equipment 2: Particular requirements – Section 25: Luminaires for IEC 60601-2-18, electrical – Part 2-18: Particular requirements for basic use in clinical areas of hospitals and health care equipment buildings safety and essential performance of endoscopic 60601-2-18, Medical electrical equipment– –Part Part 2-18: Particular requirements Medical electrical equipment 2-50: Particular requirements for for the basic IEC ISO 60601-2-50, 9680, Dentistry – Operating lights safety and essential performance of endoscopic infant phototherapy equipment  equipment CIE 17.4, International lighting vocabulary ISO 9680, Dentistry – Operating lights CIE 17.4, International lighting vocabulary Add the following new reference: BS EN 60601-2-41:2009+A1:2015 – 42–– Part 2-50:BS EN 60601-2-41:2009+A1:2015 (E) IEC 60601-2-50, Medical electrical equipment Particular requirements for the EN 60601-2-41:2009+A11:2011 basic safety and essential performance of infant equipment EN 60601-2-41:2009+A11:2011 (E) – 41 phototherapy – Index of defined terms Index of defined terms Replace the existing text of the Index with the following: CENTRAL ILLUMINANCE 201.3.101 CENTRAL ILLUMINANCE 201.3.201 DEPTH OF ILLUMINATION 201.3.102 DEPTH OF ILLUMINATION ABOVE 60% 201.3.202 DETACHABLE HANDLE 201.3.110 DETACHABLE HANDLE 201.3 210 FAIL SAFE 201.3.103 FAIL SAFE 201.3.203 HAZARD IEC 60601-1:2005, 3.39 LIGHT FIELD CENTRE 201.3.204 LIGHT FIELD CENTRE 201.3.104 LIGHT FIELD DIAMETER 201.3.205 LIGHT FIELD DIAMETER 201.3.105 LUMINAIRE FOR DIAGNOSIS 201.3.206 LUMINAIRE FOR DIAGNOSIS 201.3.106 MAJOR SURGICAL LUMINAIRE 201.3.207 MAJOR SURGICAL LUMINAIRE 201.3.107 MINOR SURGICAL LUMINAIRE ( TREATMENT LUMINAIRE ) 201.3.208 MEDICAL ELECTRICAL EQUIPMENT ( ME EQUIPMENT ) IEC 60601-1:2005, 3.63 SHADOW DILUTION 201.3.209 MEDICAL ELECTRICAL SYSTEM ( ME SYSTEM ) IEC 60601-1:2005, 3.64 SINGLE SURGICAL LUMINAIRE 201.3.213 MINOR SURGICAL LUMINAIRE ( TREATMENT LUMINAIRE ) 201.3.108 SURGICAL LUMINAIRE 201.3.211 SHADOW DILUTION 201.3.109 SURGICAL LUMINAIRE SYSTEM 201.3.212 SURGICAL LUMINAIRE 201.3.111 _ SURGICAL LUMINAIRE SYSTEM _ 201.3.112 This page deliberately left blank This page deliberately left blank This page deliberately left blank NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW British Standards Institution (BSI) BSI is the national body responsible for preparing British Standards and other standards-related publications, information and services BSI is incorporated by Royal Charter British Standards and other standardization products are published by BSI Standards Limited About us Revisions We bring together business, industry, government, consumers, innovators and others to shape their combined experience and expertise into standards -based solutions Our British Standards and other publications are updated by amendment or revision The knowledge embodied in our standards has been carefully assembled in a dependable format and refined through our open consultation process Organizations of all sizes and across all sectors choose standards to help them achieve their goals Information on standards We can provide you with the knowledge that your organization needs to succeed Find out more about British Standards by visiting our website at bsigroup.com/standards or contacting our Customer Services team or Knowledge Centre Buying standards You can buy and download PDF versions of BSI publications, including British and adopted European and international standards, through our website at bsigroup.com/shop, where hard copies can also be purchased If you need international and foreign standards from other Standards Development Organizations, hard copies can be ordered from our Customer Services team Subscriptions Our range of subscription services are designed to make using standards easier for you For further information on our subscription products go to bsigroup.com/subscriptions With British Standards Online (BSOL) you’ll have instant access to over 55,000 British and adopted European and international standards from your desktop It’s available 24/7 and is refreshed daily so you’ll always be up to date You can keep in touch with standards developments and receive substantial discounts on the purchase price of standards, both in single copy and subscription format, by becoming a BSI Subscribing Member PLUS is an updating service exclusive to BSI Subscribing Members You will automatically receive the latest hard copy of your standards when they’re revised or replaced To find out more about becoming a BSI Subscribing Member and the benefits of membership, please visit bsigroup.com/shop With a Multi-User Network Licence (MUNL) you are able to host standards publications on your intranet Licences can cover as few or as many users as you wish With updates supplied as soon as they’re available, you can be sure your documentation is current For further information, email bsmusales@bsigroup.com BSI Group Headquarters 389 Chiswick High Road London W4 4AL UK We continually improve the quality of our products and services to benefit your business If you find an inaccuracy or ambiguity within a British Standard or other BSI publication please inform the Knowledge Centre Copyright All the data, software and documentation set out in all British Standards and other BSI publications are the property of and copyrighted by BSI, or some person or entity that owns copyright in the information used (such as the international standardization bodies) and has formally licensed such information to BSI for commercial publication and use Except as permitted under the Copyright, Designs and Patents Act 1988 no extract may be reproduced, stored in a retrieval system or transmitted in any form or by any means – electronic, photocopying, recording or otherwise – without prior written permission from BSI Details and advice can be obtained from the Copyright & Licensing Department Useful Contacts: Customer Services Tel: +44 845 086 9001 Email (orders): orders@bsigroup.com Email (enquiries): cservices@bsigroup.com Subscriptions Tel: +44 845 086 9001 Email: subscriptions@bsigroup.com Knowledge Centre Tel: +44 20 8996 7004 Email: knowledgecentre@bsigroup.com Copyright & Licensing Tel: +44 20 8996 7070 Email: copyright@bsigroup.com