EN 60601-2-37-2008 en Medical electrical equipment - Part 2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitorin.pdf

1、BRITISH STANDARD BS EN 60601-2-37:2008Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipmentICS 11.040.55; 17.140.50nullnull nullnullnullnullnullnullnull nullnullnullnullnullnullnull nul

2、lnullnull nullnullnullnullnullnullnullnullnullnull nullnullnullnullnullnull nullnull nullnullnullnullnullnullnullnullnull nullnull nullnullnullnullnullnullnullnullnull nullnullnull+A1:2015BS EN 60601-2-37:2008This British Standard was published under the authority of the Standards Policy and Strateg

3、y Committee on 31 July 2008 ISBN 978 0 580 77319 8National forewordThe UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical equipment in medical practice, to Subcommittee CH/62/2, Diagnostic imaging equipment.A list of organizations represented on this subcommit

4、tee 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.Compliance with a British Standard cannot confer immunity from legal obligations.+A1:2015The British Standards In

5、stitution 2015. Published by BSI Standards Limited 2015.Amendments/corrigenda issued since publicationDate Comments 30 April 2012 Implementation of CENELEC amendment A11:2011. Annex ZZ has been revised.30 September 2015 Implementation of IEC amendment 1:2015 with CENELEC endorsement A1:2015. Annex Z

6、A amendedThis British Standard is the UK implementation of EN 60601-2-37:2008+A1:2015. It is identical to IEC 60601-2-37:2007, incorporating amendment 1 2015. It supersedes BS EN 60601-2-37:2008+A11:2011 which will be withdrawn on 13 July 2018.The start and finish of text introduced or altered by am

7、endment 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 1 is indicated by !“.EUROPEAN STANDARD EN 60601-2-37NORME EUROPENNE EUROPISCHE NORMCENELEC European Committee for ElectrotechnicalStandardiz

8、ationComit Europende NormalisationElectrotechnique Europisches Komitee frElektrotechnischeNormung Central Secretariat: ruede Stassart 35, B - 1050 Brussels 2008 CENELEC - All rightsof exploitation inany formand byany means reservedworldwide forCENELECmembers.Ref. No. EN60601-2-37:2008 EICS 11.040.55

9、; 17.140.50 English version Medical electrical equipment - Part 2-37: Particular requirements for the basic safetyand essential performanceof ultrasonic medicaldiagnosticand monitoring equipment (IEC 60601-2-37:2007)Appareils lectromdicaux - Partie 2-37: Exigences particulires pour la scurit de base

10、et les performances essentielles des appareils de diagnostic et de surveillance mdicaux ultrasons (CEI 60601-2-37:2007) Medizinische elektrische Gerte - Teil 2-37: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichenLeistungsmerkmale von Ultraschallgerten fr die medizinischeDiagno

11、se und berwachung (IEC 60601-2-37:2007) This European Standard wasapprovedby CENELECon 2007-10-01. CENELECmembers are boundtocomplywiththe CEN/CENELEC Internal Regulations which stipulate the conditionsfor givingthis European Standardthe status ofa national standard withoutany alteration.Up-to-date

12、lists and bibliographical references concerning such national standards may be obtained onapplication to theCentralSecretariat or to any CE NELEC member.This European Standard exists in three official versions (English, French, German). A versionin any otherlanguage made by translationunder therespo

13、nsibilityofaCENELEC member into its own language and notifiedto theCentralSecretariat has the same status as theofficial versions.CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany,Greece,

14、 Hungary,Iceland,Ireland,Italy,Latvia,Lithuania, Luxembourg, Malta,the Netherlands, Norway,Poland, Portugal,Romania, Slovakia, Slovenia, Spain,Sweden, Switzerland and the United Kingdom.:2008+A1August 2015ForewordThe text of document 62B/624/CDV,future edition 2 of IEC 60601-2-37, prepared by SC62B,

15、 Diagnosticimaging equipment, of IEC TC62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel Unique Acceptance Procedure and was approved by CENELEC asEN 60601-2-37 on 2007-10-01.This European Standard supersedes EN 60601-2-37:2001 + A1:2005 +A2:2005.EN60601-2-37:20

16、08 combines EN60601-2-37:2001 + A1:2005 + A2:2005 into a formcompatible with the parent EN 60601-1:2006.The following dates were fixed: latest date by which the EN has to be implemented at nationallevel by publication of an identicalnational standard or by endorsement (dop) 2008-08-01 latest date by

17、 which the national standards conflicting with the EN have to be withdrawn (dow) 2010-10-01 This European Standard has been prepared under a mandate given to CENELEC bythe European Commission and the European Free Trade Association and covers essential requirements ofEC Directive 93/42/EEC.See Annex

18、 ZZ.In this standard, the following printtypes are used: requirements and definitions: in roman type; test specifications: in italic type; informative material appearing outside of tables,such as notes, examples and references:in smaller type. Normative text oftables is alsoin asmallertype; TERMS DE

19、FINED IN C LAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED : INSMALL CAPITALS . In referring to the structure ofthis standard, the term “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of allsubdivisions (e.g. Clause 7 includes S

20、ubclauses 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 ofClause 7).References to clauses within this standard are preceded by the term “Clause” followed by the clausenumber. References to subclauses within this standard are by numb

21、er only.In this standard, the conjunctive “or” is used as an “inclusive or” so a statementis true if any combination of the conditions is true.The verbalforms used in thisstandard conform to usage described in Annex H of the ISO/IEC Directives,Part 2. For the purposes of this standard, the auxiliary

22、verb “shall” means that compliance with a requirement or a test is mandatoryfor compliance with thisstandard; “should” means that compliance with a requirement or a test is recommended but is not mandatoryforcompliance with this standard; “may”is used to describe a permissible way to achievecomplian

23、ce with a requirement or test.BS EN 60601-2-37:2008+A1:2015 IEC 60601-2-37:2008+A1:2015 (E) 2 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates thatthere is guidance or rationale related to thatitem in Annex AA.Annexes ZA and ZZ have been a

24、dded by CENELEC._ Endorsement notice The text of the International Standard IEC 60601-2-37:2007 was approved by CENELEC as a EuropeanStandard without anymodification._ ForewordThis document (EN 60601-2-37:2008/A11:2011) has been prepared by CLC/TC 62 “Electrical equipment in medical practice”. The f

25、ollowing 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 (dop) 2012-10-01 latest date by which the national standards conflicting with this document have to be withdrawn (dow) 2014-10-01 At

26、tention 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. to amendment A11European foreword to amendment A1 The text of document 62B/978/FDIS, fut

27、ure IEC 60601-2-37:2008/A1, prepared by SC 62B “Diagnostic imaging equipment“ of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-37:2008/A1:2015. The following dates are fixed: latest date by which the document

28、 has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-04-13 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-07-13 Attention is drawn to the possibility that some of the elements

29、 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. _ BS EN 60601-2-37:2008+A1:2015 IEC 60601-2-37:2008+A1:2015 (E) 3 This document has been prepared under a mandate given to CENELEC by the European Co

30、mmission and the European Free Trade Association, and supports essential requirements of EU Directive. For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 60601-2-37:2008/A11:2011. Endorsement notice The text of the International Standard IEC 60601-2-37:2007/A1

31、:2015 was approved by CENELEC as a European Standard without any modification. In the Bibliography of EN 60601-2-37:2008, the following note has to be added for the standard indicated: IEC 61157:2007 NOTE Harmonized as EN 61157:2007. IEC 60601-1-11:2015 NOTE Harmonized as EN 60601-1-11:2015. BS EN 6

32、0601-2-37:2008+A1:2015 IEC 60601-2-37:2008+A1:2015 (E) 4 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its appl

33、ication. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies.

34、 NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here: www.cenelec.eu. Addition: Publication Year Title EN/HD Year IEC 60601-1 2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

35、EN 60601-1 2006 - - + corrigendum Mar. 2010 + A1 2012 + A1 2013 - - + A12 2014 IEC 60601-2-18 2009 Medical electrical equipment - Part 2-18: Particular requirements for basic safety and essential performance of endoscopic equipment - - IEC 62127-1 2007 Ultrasonics - Hydrophones - Part 1: Measurement

36、 and characterization of medical ultrasonic fields up to 40 MHz EN 62127-1 2007 + A1 2013 + A1 2013 IEC 62359 2010 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields EN 62359 2011 _ Annex ZZ (inf

37、ormative) 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

38、of the EC Directive 93/42/EEC except as follows: Essential Requirement 6a Essential Requirement 7.4 Essential Requirement 7.5 paragraph 2 whereitis intended that any part of the general standard or applicable collateral standard, although possiblyrelevant, is not to be applied, a statement to that e

39、ffect isgiven in this particularstandard.201.2 Normativereferences!“Clause 2 of the general standard applies except as follows: Addition: IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005/AMD1:20121IEC 60601-2-18:2

40、009, Medical electrical equipment Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment IEC 62127-1:2007, Ultrasonics Hydrophones Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz IEC 62127-1:2007/AMD1:20132IEC 6235

41、9:2010, Ultrasonics Field characterization Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields _ 1There exists a consolidated edition (3.1) including IEC 60601-1:2005 and its Amendment 1 (2012). 2There exists a consolidated edition (1.

42、1) including IEC 62127-1:2007 and its Amendment 1 (2013). BS EN 60601-2-37:2008+A1:2015 IEC 60601-2-37:2008+A1:2015 (E) 9 201.3.201201.3.202COMBINED - OPERATING MODEmode of operation of ULTRASONIC DIAGNOSTIC EQUIPMENT that combines more than one DISCRETE- OPERATING MODE201.3.203201.3.204DEFAULT SETT

43、INGspecific state of control the ULTRASONIC DIAGNOSTIC EQUIPMENT will enter upon power-up, newPATIENT select, or change from non-foetalto foetal applications201.3.205DISCRETE- OPERATING MODEmode of operation of ULTRASONICDIAGNOSTIC EQUIPMENT in which thepurpose ofthe excitationof the ULTRASONIC TRAN

44、SDUCER or ULTRASONIC TRANSDUCER element group is to utilise onlyone diagnostic methodology201.3.206FULL SOFTWARE CONTROL OF ACOUSTIC OUTPUTmeans bywhich the ULTRASONIC DIAGNOSTIC EQUIPMENT manages the acousticoutputindependent of direct OPERATOR control201.3.207INVASIVE TRANSDUCER ASSEMBLYa transduc

45、er which, in whole or in part, penetrates inside thebody, either through a bodyorifice or throughthe surface ofthe bodyCRANIAL-BONE THERMAL INDEX TIC THERMAL INDEX for applications in which the ultrasound beam passes through bone near the beam entrance into the body, such as paediatric and adult cra

46、nial or neonatal cephalic applications Unit: None SOURCE: IEC 62359:2010, 3.21, modified The definition now includes a reference to neonatal cephalic applications, and the original notes have been deleted. !“BONE THERMAL INDEX TIB THERMAL INDEX for applications such as foetal (second and third trime

47、ster), in which the ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of bone Unit: None SOURCE: IEC 62359:2010, 3.17, modified The definition no longer refers to neonatal cephalic applications, and the original notes have been deleted !“201.3 Forthe purposes

48、 of this document, theterms and definitions given in the general standardand in IEC 62359, as well as the following additions apply: NOTE 1 An index of defined terms is given after the Bibliography.NOTE 2 A list of symbols used in this particular standard is found in Table 201.101.! “Terms and defin

49、itionsBS EN 60601-2-37:2008+A1:2015 IEC 60601-2-37:2008+A1:2015 (E) 10 201.3.210NON- SCANNING MODEmode of operation of ULTRASONIC DIAGNOSTIC EQUIPMENT thatinvolves a sequence ofultrasonic pulses that give rise to ultrasonic scan lines that followthe same acoustic path201.3.211PRUDENT USE STATEMENT201.3.212SCANNING MODEmode of operation of ULTRASONIC DIAGNOSTIC EQUIPMENT thatinvolves a sequence ofultrasonic pulsesthatgive rise toscan lines that do not foll