BS EN 60601-2-57-2011 Medical electrical equipment Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutu.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipmentPart 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for theraputic, diagnos

2、tic, monitoring and cosmetic/aesthetic useBS EN 60601-2-57:2011National forewordThis British Standard is the UK implementation of EN 60601-2-57:2011. It isidentical to IEC 60601-2-57:2011.The UK participation in its preparation was entrusted to Technical CommitteeEPL/76, Optical radiation safety and

3、 laser equipment.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions of acontract. Users are responsible for its correct application. BSI 2011ISBN 978 0 580 58936 2ICS 11.040.50; 11

4、.040.60Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of the StandardsPolicy and Strategy Committee on 30 June 2011.Amendments issued since publicationAmd. No. Date Text affectedBRITISH STANDARDBS EN 60601-2-57:

5、2011EUROPEAN STANDARD EN 60601-2-57 NORME EUROPENNE EUROPISCHE NORM April 2011 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Management Centre: Avenue Marnix 17, B - 1000 Brussels 2011

6、CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-57:2011 E ICS 11.040.50; 11.040.60 English version Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-las

7、er light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use (IEC 60601-2-57:2011) Appareils lectromdicaux - Partie 2-57: Exigences particulires pour la scurit de base et les performances essentielles des appareils source de lumire non-laser prvus pour des ut

8、ilisations thrapeutiques, de diagnostic, de surveillance et de cosmtique/esthtique (CEI 60601-2-57:2011) Medizinische elektrische Gerte - Teil 2-57: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Gerten mit Nicht-Laser-Lichtquellen fr die Anwendung in d

9、er Therapie, Diagnose, berwachung und fr kosmetische/sthetische Zwecke (IEC 60601-2-57:2011) This European Standard was approved by CENELEC on 2011-03-07. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard th

10、e 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, Ge

11、rman). 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, Bulgar

12、ia, Croatia, 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. BS EN 60601-

13、2-57:2011EN 60601-2-57:2011 - 2 - Foreword The text of document 76/438/FDIS, future edition 1 of IEC 60601-2-57, prepared by IEC TC 76, Optical radiation safety and laser equipment, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-57 on 2011-03-07. Attention i

14、s drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent rights. The following dates were fixed: latest date by which the EN has to be implemented at national level

15、by publication of an identical national standard or by endorsement (dop) 2011-12-07 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2014-03-07 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the E

16、uropean 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

17、notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 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 seventee

18、n numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 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

19、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 stan

20、dard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. 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

21、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

22、 rationale related to that item in Annex AA. BS EN 60601-2-57:2011- 3 - EN 60601-2-57:2011 Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-2-57:2011 was approved by CENELEC as a European Standard without any modification. _ BS EN 60

23、601-2-57:2011EN 60601-2-57:2011 - 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

24、. 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: Additi

25、on: Publication Year Title EN/HD Year IEC 60947-3 - Low-voltage switchgear and controlgear - Part 3: Switches, disconnectors, switch-disconnectors and fuse-combination units EN 60947-3 - IEC 62471 (mod) - Photobiological safety of lamps and lamp systems EN 62471 - ISO 3864-2 - Graphical symbols - Sa

26、fety colours and safety signs - Part 2: Design principles for product safety labels - - BS EN 60601-2-57:2011- 5 - EN 60601-2-57:2011 Annex ZZ (informative) Coverage of Essential Requirements of EU Directives This European Standard has been prepared under a mandate given to CENELEC by the European C

27、ommission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EU Directive 93/42/EEC. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive

28、concerned. WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this standard. _ BS EN 60601-2-57:2011 2 60601-2-57 IEC:2011 CONTENTS INTRODUCTION . 7 201.1 Scope, object and related standards 8 201.2 Normative references 10 201.3 Terms an

29、d definitions 10 201.4 General requirements 13 201.5 General requirements for testing ME EQUIPMENT . 13 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13 201.7 ME EQUIPMENT identification, marking and documents 15 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 19 201.9 Protecti

30、on against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 20 201.10 Protection against unwanted and excessive radiation HAZARDS 20 201.11 Protection against excessive temperatures and other HAZARDS 21 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 21 201.13

31、 HAZARDOUS SITUATIONS and fault conditions . 22 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23 201.15 Construction of ME EQUIPMENT . 23 201.16 ME SYSTEMS. 23 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 23 Annexes . 23 Annex AA (informative) Particular guidance and

32、 rationale 24 Annex BB (informative) Exposure limit values 26 Annex CC (informative) Protective eyewear for LS EQUIPMENT 30 Annex DD (informative) Summary of MANUFACTURERS requirements 31 Annex EE (informative) Symbols on marking 32 Bibliography 33 Index of defined terms used in this particular stan

33、dard 34 Figure 201.101 Example of explanatory label for a device with multiple HAZARD spectral regions 18 Figure 201.102 Warning label HAZARD symbol . 19 Table 201.101 EMISSION LIMITS for risk groups of LS EQUIPMENT 14 Table 201.102 Risk group time base criteria for classification of LS EQUIPMENT 15

34、 Table 201.103 Applicable ANGLE OF ACCEPTANCE for the assessment of accessible emission from LS EQUIPMENT . 15 Table 201.104 Requirements for labelling of LS EQUIPMENT according to risk group classification . 17 Table BB.1 EXPOSURE LIMIT values for non-coherent OPTICAL RADIATION . 26 Table BB.2 S()

35、dimensionless, 200 nm to 400 nm 28 Table BB.3 B (), R () dimensionless, 300 nm to 1 400 nm . 29 BS EN 60601-2-57:201160601-2-57 IEC:2011 3 Table DD.1 Summary of MANUFACTURERS requirements . 31 Table EE.1 Symbols, references and descriptions 32 BS EN 60601-2-57:201160601-2-57 IEC:2011 7 INTRODUCTION

36、This particular standard amends and supplements IEC 60601-1:2005 (third edition): Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance. The requirements of this particular standard should be taken as the minimum to comply with, in order to achieve a re

37、asonable level of safety and reliability during operation and application of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use. An asterisk (*) notes clauses for which there is rationale comment in Annex AA. It is considered that knowledge o

38、f the reasons for these requirements will facilitate the proper application of this particular standard and be of use in any revision that may be necessitated by changes in clinical practice or as a result of developments in technology. BS EN 60601-2-57:2011 8 60601-2-57 IEC:2011 MEDICAL ELECTRICAL

39、EQUIPMENT Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use 201.1 Scope, object and related standards Clause 1 of the general standard1)applies, except as f

40、ollows: 201.1.1 Scope Replacement: This International Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment incorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create non-visual ph

41、oto-biological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment (LS EQUIPMENT). This particular standard does not apply to equipment for sun tanning, for ophthalmic instruments or for

42、infant phototherapy. NOTE Safety requirements in this particular standard are intended to address only HAZARDS to the eye and skin; hazards to internal tissues are not included in its scope. LS EQUIPMENT may consist of a single or multiple sources of OPTICAL RADIATION, with or without power supply,

43、or may be incorporated into a complex system that includes optical, electrical or mechanical systems or sources of other radiation. NOTE Annexes AA to EE have been included for purposes of general guidance and to illustrate many typical cases. However, the annexes should not be regarded as definitiv

44、e or exhaustive. 201.1.2 Object Replacement: The objects of this particular standard are: to establish optical radiation safety, basic safety and essential performance requirements for LS EQUIPMENT; to specify requirements for the MANUFACTURER to supply information and establish procedures so that p

45、roper precautions can be adopted; to provide warning to individuals of HAZARDS associated with accessible OPTICAL RADIATION from LS EQUIPMENT through signs, labels and instructions; to reduce the possibility of injury by minimizing unnecessary accessible OPTICAL RADIATION; to provide means of improv

46、ed control of the HAZARDS related to OPTICAL RADIATION through protective features and to assist safe use of LS EQUIPMENT; _ 1)The general standard is IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance. BS EN 60601-2-57:201160601-2-

47、57 IEC:2011 9 to protect persons against other HAZARDS resulting from the operation and use of LS EQUIPMENT. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and in Clause 201.2 of this

48、 particular standard. All published collateral standards in the IEC 60601 series apply as published. 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as approp

49、riate for the particular ME EQUIPMENT under consideration, and may add other basic safety and essential performance requirements. A requirement of a particular standard takes priority over the general standard. For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this