EN 80601-2-59-2009 en Medical electrical equipment - Part 2-59 Particular requirements for the basic safety and essential performance of screening thermographs for human febrile te.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipmentPart 2-59: Particular requirements for the basic safetyand essential performance of screening thermographsfor human febrile temperature screeningBS EN

2、 80601-2-59:2009National forewordThis British Standard is the UK implementation of EN 80601-2-59:2009.The UK participation in its preparation was entrusted by Technical CommitteeCH/62, Electromedical equipment in medical practice, to SubcommitteeCH/62/4, Electromedical equipment, with contribution f

3、rom CH/121/5, Lungventilators, tracheal tubes and related equipment.A list of organizations represented on this subcommittee 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 applic

4、ation. BSI 2010 ISBN 978 0 580 55751 4 ICS 11.040.55Compliance 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 30 April 2010.Amendments/corrigenda issued since publicationD

5、ate Text affectedBRITISH STANDARDBS EN 80601-2-59:2009It is identical to IEC 80601-2-59:2008, incorporating corrigendum April 2009. The start and finish of text introduced or altered by corrigendum is indicatedin the text by tags. Text altered by IEC corrigendum April 2009 is indicated inthe text by

6、 . EUROPEAN STANDARD EN 80601-2-59 NORME EUROPENNE EUROPISCHE NORM December 2009 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: Avenue Marnix 17, B - 1000 Brussels 2

7、009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 80601-2-59:2009 E ICS 11.040.55 English version Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening ther

8、mographs for human febrile temperature screening (IEC 80601-2-59:2008 + corrigendum 2009) Appareils lectromdicaux - Partie 2-59: Exigences particulires pour la scurit de base et les performances essentielles des imageurs thermiques pour le dpistage des humains fbriles (CEI 80601-2-59:2008 + corrigen

9、dum 2009) Medizinische elektrische Gerte - Teil 2-59: Besondere Anforderungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Wrmebildkameras fr Reihenuntersuchungen von Menschen auf Fieber (IEC 80601-2-59:2008 + Corrigendum 2009) This European Standard was approved by CENELEC

10、 on 2009-11-17. 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

11、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

12、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, Lu

13、xembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 80601-2-59:2009EN 80601-2-59:2009 - 2 - Foreword The text of document 62D/697/FDIS, future edition 1 of IEC 80601-2-59, prepared by SC 62D, Electromedical

14、 equipment, of IEC TC 62, Electrical equipment in medical practice, and SC 3, Lung ventilators and related equipment, of ISO TC 121, Anaesthetic and respiratory equipment, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 80601-2-59 on 2009-11-17. The following dates w

15、ere 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) 2010-09-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2012-12-01 This European Standard has been

16、 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 specific

17、ations: 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 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring

18、 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 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 su

19、bclauses 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 i

20、f 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 2. For the purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance w

21、ith 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

22、the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. BS EN 80601-2-59:2009- 3 - EN 80601-2-59:2009 Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 80601-2-59:2008 + co

23、rrigendum April 2009 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following note has to be added for the standard indicated: ISO/IEC 17025 NOTE Harmonized as EN ISO/IEC 17025:2005 (not modified). _ BS EN 80601-2-59:2009EN 806

24、01-2-59:2009 - 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 refer

25、ences, 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: Publication Year Title EN

26、/HD Year Addition: ISO/TR 13154 -1)Medical electrical equipment - Deployment, implementation and operational guidelines for indentifying febrile humans using a screening thermograph - - ASTM E1213-97 2002 Standard Test Method for Minimum Resolvable Temperature Difference for Thermal Imaging Systems

27、- - 1)Undated reference. BS EN 80601-2-59:2009- 5 - EN 80601-2-59:2009 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 it

28、s scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC with the exception of Essential Requirements 3 and 10.1. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concern

29、ed. WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard. _ BS EN 80601-2-59:2009 2 CONTENTS INTRODUCTION.5 201.1 Scope, object and related standards.6 201.2 Normative references .7 201.3 Terms and definitions .8 201.4 Genera

30、l requirements .10 201.5 General requirements for testing of ME EQUIPMENT 10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS .11 201.7 ME EQUIPMENT identification, marking and documents .11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT .11 201.9 Protection against mechanical HAZA

31、RDS of ME EQUIPMENT and ME SYSTEMS .12 201.10 Protection against unwanted and excessive radiation HAZARDS .12 201.11 Protection against excessive temperatures and other HAZARDS .12 201.12 Accuracy of controls and instruments and protection against hazardous outputs .12 201.13 HAZARDOUS SITUATIONS an

32、d fault conditions 13 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 13 201.15 Construction of ME EQUIPMENT.13 201.16 ME SYSTEMS13 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .13 201.101 Laboratory accuracy of a screening thermograph14 201.102 Screening thermograph ala

33、rm conditions 17 Annexes .18 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS18 Annex AA (informative) Particular guidance and rationale20 Annex BB (normative) CALIBRATION SOURCE .26 Annex CC (informative) Reference to the essential principles 27 Bibl

34、iography29 Index of defined terms used in this particular standard34 Figure AA.1 Relative drift of 4 DETECTORS as a function of time24 Table 201.101 Distributed ESSENTIAL PERFORMANCE requirements 10 Table 201.C.101 ACCOMPANYING DOCUMENTS, instructions for use of a SCREENING THERMOGRAPH .18 Table 201

35、.C.102 ACCOMPANYING DOCUMENTS, technical description of a SCREENING THERMOGRAPH .19 Table AA.1 Example of relevant uncertainty terms for a SCREENING THERMOGRAPH .22 Table CC.1 Correspondence between this particular standard and the essential principles 27 BS EN 80601-2-59:2009EN 80601-2-59:2009 5 IN

36、TRODUCTION The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of ME EQUIPMENT for human febrile temperature screening. This document describes ME EQUIPMENT that uses infrared technology to detect naturally

37、 emitted heat at the skin surface of the FACE. Such ME EQUIPMENT can be useful at ports-of-entry or ports-of-exit and the entrances to buildings under indoor environmental conditions to separate febrile from afebrile individuals to help prevent the spread of communicable diseases. Care can be needed

38、 when evaluating individuals under changing environmental conditions, but the inner canthus of the eye has been demonstrated to be a robust measurement site and is supplied by the internal carotid artery. 401)A body core temperature of 38 C or above was used as the criterion to restrict traveling du

39、ring the SARS (severe acute respiratory syndrome) epidemic (April 2003). 73 The US Center for Disease Control advises that SARS typically begins with a temperature above 38 C, which is 1 C higher than normal human body core temperature which averages around 37 C. 29 It is hard to give an accurate as

40、sessment of how many people were checked by infrared temperature measurements in China during the SARS epidemic. There is official Chinese government data indicating that during a two-month period in the spring of 2003, 30 million travelers were screened in China. From this cohort, 9 292 travelers w

41、ith elevated temperature were detected and 38 were suspected of being SARS carriers. SARS was diagnosed in 21 of these cases. All elevated temperatures were confirmed using traditional clinical temperature measurements of body temperature. Although it is hard to determine the human bodys core temper

42、ature accurately by infrared measurement of SKIN TEMPERATURE, it is a potential method for screening for elevated temperature values. 36 73 75 This particular standard amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment Part 1: General requirements for safety and e

43、ssential performance, hereinafter referred to as the General Standard (see 1.4). The requirements are followed by specifications for the relevant tests. A “General guidance and rationale“ section giving some explanatory notes, where appropriate, about the more important requirements is included in a

44、nnex AA. It is considered that knowledge of the reasons for these requirements will not only facilitate the proper application of the standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, this annex

45、 does not form part of the requirements of this standard. 1)Figures in square brackets refer to the Bibliography. BS EN 80601-2-59:2009EN 80601-2-59:2009 6 MEDICAL ELECTRICAL EQUIPMENT Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for hum

46、an febrile temperature screening 201.1 Scope, object and related standards Clause 1 of the general standard2)applies, except as follows: 201.1.1 * Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SCREENING THERMOGRAPHS intended to be used for th

47、e individual non-invasive febrile temperature screening of humans under indoor environmental conditions, hereafter referred to as ME EQUIPMENT. This International Standard sets laboratory characterization test limits for the SCREENING THERMOGRAPH. NOTE A SCREENING THERMOGRAPH is intended for screeni

48、ng and detection of human subjects with SKIN TEMPERATURES elevated above normal. An elevated SKIN TEMPERATURE needs to be followed up by a subsequent temperature measurement using a clinical thermometer (see IEC 80601-2-56). If a clause or subclause is specifically intended to be applicable to ME EQ

49、UIPMENT 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. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for SCREENING THERMOGRAPHS as defined in 201.3.209. 201.1.3 Collateral standards Addition: This par