1、BSI Standards PublicationMedical electrical equipmentPart 2-54: Particular requirements for the basicsafety and essential performance of X-ray equipment for radiography and radioscopyBS EN 60601-2-54:2009+A1:2015 In corporating corrigendum April20 10National forewordThe UK participation in its prepa
2、ration was entrusted by Technical CommitteeA 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 acontract. Users are responsible for its correct application.ISBN 978 0 580 856
3、71 6ICS 11.040.50Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of the StandardsPolicy and Strategy Committee on 3 1March 2010.Amendments/corrigenda is sued since public ationDate Text affectedBRITISH STANDARDBS
4、 EN 60601-2-54:2009+A1:201530 April 2 010 Supersession details a mendedThis British Standard is the UK implementation of EN 60601-2-54:2009+A1:2015. It is identical to BS EN 60601-2-54:2009 which will be withdrawn on 22 May 2018.CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/
5、2, Diagnostic imaging equipment. The British Standards Institution 2015. Published by BSI Standards Limited 201531 July 2015 Implementation of IEC amendment 1:2015 with CENELEC endorsement A1:2015. Annex ZA amendedThe start and finish of text introduced or altered by amendment is indicated in the te
6、xt 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 !“.IEC 60601-2-54:2009, incorporating amendment 1:2015. It supersedes EUROPEAN STANDARD EN 60601-2-54:2009+A1NORME EUROPENNE EUROPISCHE NORMCENELEC Euro
7、pean Committee forElectrotechnicalStandardization Comit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr Elektrotechnische NormungCentral Secretariat:Avenue Marnix 17, B -1000 Brussels 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELE
8、Cmembers.Ref.No. EN 60601-2-54:2009 EICS11.040.50English versionMedical electricalequipment - Part 2-54: Particular requirementsfor the basic safetyand essential performance of X-rayequipment for radiographyand radioscopy(IEC 60601-2-54:2009+A1:2015)A ppareils lectromdicaux -Partie 2-54: Exigences p
9、articulires pour la scurit de base et les performances essentielles des appareils rayonnement X utiliss pour la radiographieetla radioscopie(CEI 60601-2-54:2009)Medizinische elektrische Gerte -Teil 2-54: Besondere Festlegungen fr die Sicherheit und die wesentlichen Leistungsmerkmalevon Rntgeneinrich
10、tungen fr Radiographie und Radioskopie(IEC 60601-2-54:2009)This European Standard was approved by CENELEC on 2009-08-01. CENELEC members are bound to complywith the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard wit
11、hout any alteration. Up-to-date lists and bibliographical referencesconcerning such national standards maybe obtained onapplication to the Central Secretariat or to any CENELECmember. This European Standard exists in three official versions (English, French, German). A version in any otherlanguage m
12、ade by translation under the responsibility of a CENELEC member into its own language and notifiedto the Central Secretariat has the same status as the official versions.CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, theCzech Republic, Denmark, Es
13、tonia, 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.May 2015Foreword The textofdocument 62B/735/FDIS, future edition 1 o
14、f IEC 60601-2-54, prepared bySC 62B, Diagnosticimaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to theIEC-CENELEC parallel vote and was approved byCENELEC asEN 60601-2-54 on 2009-08-01.EN 60601-2-54 was developed foruse with EN 60601-1:2006. This European Stan
15、dard supersedes EN 60601-2-7:1998, EN 60601-2-32:1994 and EN 60601-2-28:1993(partially).The following dates were fixed: latestdate by which the EN has to be implemented at nationallevel bypublication of an identicalnational standardorbyendorsement (dop) 2010-05-01 latestdate by which the national st
16、andards conflictingwith the EN have to be withdrawn (dow) 2012-08-01This European Standardhas been prepared under a mandate given to CENELEC by the EuropeanCommission and the European Free Trade Association and covers essential requirements of EC Directive MDD (93/42/EEC).See Annex ZZ.In this standa
17、rd, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outside of tables,such as notes,examplesand references: in smaller type. Normative text oftables is also in a smallertype. T ERMS DEFINED IN CLAUSE 3 OF
18、THE GENERAL STANDARD, IN THISPARTICULAR 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 ofallsubdivisions (e.g. Clause7 includes subclauses 7.1, 7.2, etc.); “su
19、bclause” means anumbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are allsubclauses ofClause7).References to clauses within this standard are preceded by the term “Clause” followed by the clausenumber. References to subclauses within this particularstandard are by number only.In this standar
20、d, the conjunctive “or” is used as an “inclusive or”so a statement is true if anycombinationof the conditions is true.The verbal formsused in this standard conformto usage described in Annex H of the ISO/IEC Directives,Part2.For the purposes of this standard, the auxiliary verb: “shall” means that c
21、ompliance with a requirement or a testismandatoryfor compliance with thisstandard; “should” means that compliance with a requirement or a testisrecommended but is not mandatoryforcompliance with this standard; “may”isused to describe apermissible wayto achievecompliance with a requirement or test. B
22、S EN 60601-2-54:2009+A1:2015 EN 60601-2-54:2009+A1:2015 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 that item in Annex AA.Annexes ZA and ZZ have been added by CENELEC._Endorsement noticeT
23、he textofthe International Standard IEC 60601-2-54:2009 wasapproved by CENELEC asa European Standard without anymodification.In the official version, for B ibliography, the following notes have to be added forthe standards indicated:1IEC 60627 NOTE Harmonized as EN 60627:2001 (not modified).2IEC 612
24、67 NOTE Harmonized as EN 61267:2006 (not modified).3ISO 4090 NOTE Harmonized as EN ISO 4090:2004 (not modified).10 IEC60601-2-7 NOTE Harmonized as EN 60601-2-7:1998 (not modified).11 IEC60601-2-28 NOTE Harmonized as EN 60601-2-28:1993 (not modified).12 IEC60601-2-32 NOTE Harmonized as EN 60601-2-32:
25、1994 (not modified).13 IEC60601-1-8 NOTE Harmonized as EN 60601-1-8:2007 (not modified).14 IEC60601-1-10 NOTE Harmonized as EN 60601-1-10:2008 (not modified).15 IEC60601-2-43 NOTE Harmonized as EN 60601-2-43:2000 (not modified)._Foreword to amendment A1 The text of document 62B/929/CDV, future IEC 6
26、0601-2-54:2009/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 60601-2-54:2009/A1:2015. The following dates are fixed: latest date by which the document has to b
27、e implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-02-22 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-05-22 Attention is drawn to the possibility that some of the elements of this
28、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 re
29、quirements of EU Directive(s). For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 60601-2-54:2009. 3 BS EN 60601-2-54:2009+A1:2015 EN 60601-2-54:2009+A1:2015Endorsement notice The text of the International Standard IEC 60601-2-54:2009/A1:2015 was approved by C
30、ENELEC as a European Standard without any modification. In the Bibliography of EN 60601-2-54:2009, replace notes 1 and 15 by the following notes: 1 IEC 60627 NOTE Harmonized as EN 60627. 15 IEC 60601-2-43 NOTE Harmonized as EN 60601-2-43. In the Bibliography of EN 60601-2-54:2009, the following note
31、s have to be added for the standards indicated: 16 IEC 60601-1-11 NOTE Harmonized as EN 60601-1-11. 17 IEC 60601-1-12 NOTE Harmonized as EN 60601-1-12. BS EN 60601-2-54:2009+A1:2015 EN 60601-2-54:2009+A1:2015 4 A nnex ZA(normative)Normative references to internationalpu blicationswith their correspo
32、nding European publicationsAnnex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD YearReplace the reference to IEC 60601-1-3 by:Addition:IEC60336 - 1) Medical electrical equipment -X-raytube assemblies formedical diagnosis -Characteristics of focal spotsEN 6033620052)IE
33、C 605802000 Medical electrical equipment -Dose area product metersEN 605802000IEC/TR60788 2004 Medical electrical equipment -Glossary ofdefined terms IEC60806 - 1) Determination of the maximumsymmetrical radiation field from a rotating anode X-raytube formedical diagnosisEN 6080620042)IEC 62220-1200
34、3 Medical electrical equipment -Characteristicsof digital X-rayimagingdevices -Part1:Determination of the detective quantumefficiencyEN 62220-120041) Undated reference.2) Valid edition at date of issue.NOTE 1 When an International Publication has been modified by common modifications, indicated by (
35、mod), the relevant EN/HD applies. NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here: www.cenelec.eu. IEC 60601-1-3 - + A1 - 2008 - 2013 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential p
36、erformance - Collateral Standard: Radiation protection in diagnostic X-ray equipment EN 60601-1-3 + corrigendum Mar. + A1 + A1/AC 2008 2010 2013 2014 IEC 60601-1 - + A1 - - 2005 - 2012 - - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601
37、-1 + corrigendum Mar. + A1 + A1/AC + A12 2006 2010 2013 2014 2014 5 BS EN 60601-2-54:2009+A1:2015 EN 60601-2-54:2009+A1:2015The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cite
38、d applies. For undated references, the latest edition of the referenced document (including any amendments) applies.Annex ZZ(informative)Coverage of Essential RequirementsofECDirectivesThis European Standardhas been prepared under a mandate given to CENELEC by the EuropeanCommission and the European
39、 Free Trade Association and within itsscope the standard coversallrelevant essential requirements as given in Annex I of the EC Directive 93/42/EEC. Compliance with this standard provides one meansofconformitywith the specified essentialrequirements of the Directive concerned.WARNING: Other requirem
40、ents and other EC Directivesmay be applicable to the products falling withinthe scope of this standard._BS EN 60601-2-54:2009+A1:2015 EN 60601-2-54:2009+A1:2015 6 CONTENTSINTRODUCTION.9201.1 Scope, object and related standards.11201.2 Normative references.12201.3 Terms and definitions. 13201.4 Gener
41、al requirements.14201.5 General requirements for testing of ME EQUIPMENT 15201.6 Classification of ME EQUIPMENT and ME SYSTEMS15201.7 ME EQUIPMENT identification, marking and documents.15201.8 Protection against electrical HAZARDS from ME EQUIPMENT.18201.9 Protection against MECHANICAL HAZARDS of ME
42、 EQUIPMENT and ME SYSTEMS.21201.10 Protection against unwanted and excessive radiation HAZARDS.25201.11 Protection against excessive temperatures and other HAZARDS .25201.12 Accuracyof controlsand instruments and protection against hazardousoutputs .26201.13 HAZARDOUS SITUATIONS and fault conditions
43、 26201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).26201.15 Construction of ME EQUIPMENT.26201.16 ME SYSTEMS26201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS.26202 Electromagnetic compatibility Requirements and tests.26203 Radiation protection in diagnostic X-ray equipment.
44、27Annexes .62Annex C(informative)Guide to markingand labelling requirements for ME EQUIPMENTand ME SYSTEMS63Annex AA (informative) Particular guidance and rationale65Bibliography68Index of defined terms used in this particular standard69Figure 203.101 Zone of EXTRA-FOCAL RADIATION.45Figure 203.102 D
45、iscrepancies in covering the IMAGE RECEPTION AREA.47Figure 203.103 Discrepancies in visual indication of the X-RAY FIELD .51Figure 203.104 Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY SOURCE ASSEMBLY below the PATIENT SUPPORT).59Figure 203.105 Testing for STRAY RADIATION (X-RAY BEAM
46、 vertical with X-RAYSOURCEASSEMBLY below the PATIENT SUPPORT)59Figure 203.106 Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY SOURCE ASSEMBLY above the PATIENT SUPPORT).60Figure 203.107 Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAYSOURCEASSEMBLY above the PATIENT SUPPORT)
47、61Table 201.101 Distributed ESSENTIAL PERFORMANCE requirements14Table 203.101 Tests for verifying reproducibility and linearity33 7 BS EN 60601-2-54:2009+A1:2015 60601-2-54 IEC:2009+A1:2015Table 203.102 Loadings for testing AUTOMATIC EXPOSURE CONTROLS.35Table 203.103 ATTENUATION for the measurement
48、of AIR KERMA .37Table 203.104 ATTENUATION EQUIVALENT of items in the X-RAY BEAM.53Table 203.105 Application categories 55Table 203.106 Requirements for PRIMARY PROTECTIVE SHIELDING55Table 203.107 STRAY RADIATION in SIGNIFICANT ZONES OF OCCUPANCY .57Table 201.C.101 Marking on the outside of ME EQUIPM
49、ENT or its parts63Table 201.C.102 Subclauses requiring statements in ACCOMPANYING DOCUMENTS.63BS EN 60601-2-54:2009+A1:2015 60601-2-54 IEC:2009+A1:2015 8 INTRODUCTION This particularstandardhas been prepared to provide, based on IEC60601-1:2005(thirdedition) and its collaterals, a complete set of safety requirements forME EQUIPMENT forRADIOGRAPHY and RADIOSCOPY . While the previously existing standards forsuchequipmentwere dedicated t
