BS EN 60601-2-45:2011+A1:2015 BSI Standards Publication Medical electrical equipment Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices BS EN 60601-2-45:2011+A1:2015 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN 60601-2-45:2011+A1:2015 It is identical to IEC 60601-2-45:2011, incorporating amendment 1:2015 It supersedes BS EN 60601-2-45:2011 which will be withdrawn on 23 July 2018 The start and finish of text introduced or altered by amendment is indicated in the text by tags Tags indicating changes to IEC text carry the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/62/2, Diagnostic imaging 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 79944 ICS 11.040.50 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 May 2011 Amendments/corrigenda issued since publication Date Text affected 31 October 2015 Implementation of IEC amendment 1:2015 with CENELEC endorsement A1:2015 Annex ZA updated EUROPEAN STANDARD BS EBNS6E0N60610-620-14-52:-24051:210+1A11:2015 NORME EUROPÉENNE EUROPÄISCHE NORM EN 6600660011 22 4455:2011+A1 ICS 11.040.50 SMeaprtcehm2b0e1r12015 Supersedes EN 60601-2-45:2001 English version Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices (IEC 60601-2-45:2011) Appareils électromédicaux - Medizinische elektrische Geräte - Partie 2-45: Exigences particulières pour Teil 2-45: Besondere Festlegungen für die la sécurité de base et les performances Sicherheit einschließlich der wesentlichen essentielles des appareils de Leistungsmerkmale von Röntgen- mammographie rayonnement X et des Mammographiegeräten und appareils mammographiques mammographischen Stereotaxie- stéréotaxiques Einrichtungen (CEI 60601-2-45:2011) (IEC 60601-2-45:2011) This European Standard was approved by CENELEC on 2011-03-17 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 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, 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 CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung Management Centre: Avenue Marnix 17, B - 1000 Brussels © 2011 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members Ref No EN 60601-2-45:2011 E BS EN 60601-2-45:2011+A1:2015 – – EBNS E60N660016-20-14-52:-24051:12+0A111:2015 - - EN 60601-2-45:2011 Foreword The text of document 62B/817/FDIS, future edition of IEC 60601-2-45, 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 was approved by CENELEC as EN 60601-2-45 on 2011-03-17 Attention is 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 This European Standard supersedes EN 60601-2-45:2001 EN 60601-2-45:2011 has been aligned to EN 60601-1:2006 and to EN 60601-1-3:2008 + corrigendum March 2010 Further modifications have been made with respect to the current technology of MAMMOGRAPHIC X-RAY EQUIPMENT The following dates were fixed: – latest date by which the EN has to be implemented (dop) 2011-12-17 at national level by publication of an identical national standard or by endorsement – latest date by which the national standards conflicting (dow) 2014-03-17 with the EN have to be withdrawn 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 recommendedBbSutEisNn6o0t6m01a-n2d-a4t5o:r2y0f1o1r compliance with this standard; - - EN 60601-2-45:2011 – “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 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 - - BS EN 60601-2-45:2011 – – BS EN 60601E-2N-4650:26011-2+-A415:20151 EN 60601-2-45:2011+A1:2015 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 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 (93/423/EEC) See Annex ZZ Annexes ZA and ZZ have been added by CENELEC Endorsement notice The text of the International Standard IEC 60601-2-45:2011 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 60601-2-7:1998 NOTE Harmonized as EN 60601-2-7:1998 (not modified) IEC 60601-2-28:2010 NOTE Harmonized as EN 60601-2-28:2010 (not modified) IEC 60601-2-32:1994 NOTE Harmonized as EN 60601-2-32:1994 (not modified) IEC 60664-1:2007 NOTE Harmonized as EN 60664-1:2007 (not modified) ISO 4090:2001 NOTE Harmonized as EN ISO 4090:2004 (not modified) EN 606IS0O1-1220-4525:2011/A1:201N5OTE Harmonized as EN ISO 12052 (not modified) European foreword Foreword to amendment A1 The text of document 62B/917/CDV, future IEC 60601-2-45:2011/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 60601-2-45:2011/A1:2015 The following dates are fixed: • latest date by which the document has to be (dop) 2016-04-23 implemented at national level by (dow) 2018-07-23 publication of an identical national standard or by endorsement • latest date by which the national standards conflicting with the document have to be withdrawn 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 For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 60601-2-45:2011 Endorsement notice The text of the International Standard IEC 60601-2-45:2011/A1:2015 was approved by CENELEC as a European Standard without any modification In the Bibliography of EN 60601-2-45:2011, the following note has to be added for the standard indicated: IEC 61223-3-2:2007 NOTE Harmonized as EN 61223-3-2:2008 (not modified) EN 60601-2-45:2011 - - BS EN 60601-2-45:2011+A1:2015 AAnnn–ne4ex–xZZAA BESNE6N060610-21 425-4:250:2110+11A1:2015 BS EN 60601-2-45:2011 (n(noormrmaatitvivee) ) EN 60601-2-45:2011 - - EN 60601-2-45:2011 - - NoNrmoramtiavteivreerfeefreernecnecsestotoininteterrnnaattiioonnaall ppuubblliiccaattiioonnss witwhitthhethireicrocrorrersepspoonnAddinninngegxEEuZurArooppeeaann ppuubblliiccaattiioonnss Annex ZA (normative) TThhee ffoolllloowwiinngg dreofceuremnecnetds,dioncwumhoelnetsorarien ipnadri(ts,npoaerrnemsanabotlriemvefao)trivtehley arepfpelriceantcioend oinf tthhiiss ddooccuummeenntt aFnodr daareted irnedfeisrpeenncseasb, loenflyorthitesNeoadpriptmiloicnaattciiovitened rFaeopfrpeldrieeastn.ecdFeorrsefuetnordeanintceetdes,rrenofnaelrtyeionthcneeasle, dpthitueiobnlalitcceistaettdieodaniptisopnlieosf tFhoer ruenfedraetnecded rdeofecruemnecenst ,(itnhceluladtinegsNtaeondryimtiaomanteoinvf dtehmereerneftfsee)rraeepnnpccelieedssd otcouminetnetr(ninactluiodinngalanpyuabmliecnadtmioenntss) applies with their corresponding European publications with their corresponding European publications NNOOTTEE 1WWhheennananinItnetrenrantaiotnioanlapluPbulicbalictioatniohnashabseebneemnodmifoieddifiebdy cboymcmomonmmonodmifiocadtifioicnasti,oinnsd,iciantdeidcabteyd(mbyod()m, tohde),rethleevarnetleEvaNn/Ht D EaTNphp/eHlieDfso.alploplwieisn g referenced documents are indispensable for the application of this document For dated rTehfeerefonllcoewsi,nognrleyfethreenecdeidtiodnoccuitmedenatpspalirees.inFdoisrpuenndsaatbelde rfeofretrheencaepsp,litchaetiolanteosft tehdisitidooncoufmtehnet.reFfoerrednacteedd NAdreOonfTcenEureemx2neZcUneApts-o(t,oinf-odcEnalNtuleyd6itinnh0fgoe6r0mae1nad-tyii1otina:o2mn0on0ec6nitthdeaemdplpaeatlneipestpsts)l,iveaeesrpxs.pcioFlenieopssrto.auf snthdfeoaltEloeuwdrospr:eeafenreSntacnedasr,dsthleisteladteinsttheisdiatinonnexoifs thaveailraebfleerehenrcee: d wdwowc.ucmeneelnetc.(einucluding any amendments) applies PNOuTbElicaWtihoenn an internatioYneaal prublicTatitolen has been modified by common modifications, indicaEteNd/bHyD(mod), the relevanYt EeNa/rHD AaNpOnpTlniEese.xWhZenAanoifntEernNati6on0a6l p0u1bli-c2at-io4n5h:a2s0b1ee1n ampodpifileidebsy,ceomxmcoenpmtoadisficaftoionllso, iwndsica:ted by (mod), the relevant EN/HD Rapepplielas.ce IEC 60601-1-2 and IEC 60601-1-3 by: IPAEunCbnl6eic0xa6Zti0oA1n-o1f-2EN 606Y20e01a0-1r7:200MT6ietaldepicpalileesl,eecxtrciceaplt eaqsufioplmloewnst: - ENE/HND60601-1-2 Yea2r007 Annex ZA of EN 60601-1:2006 applies, except as follows: 2010 (mod) Part 1-2: General requirements for basic + corr March RPeubpllicaacteionthe existinYgearrefesrTeaifntelectyeasntdoeIsEsCen6ti0al6p0e1r-f1or-m2:a2n0c0e7- aCnodllaItEerCal60E6N0/1H-D1-3:2008 by thYeear fPoulbloliwcaitniogn: Year Title EN/HD standard: Electromagnetic compatibility - Year Replace IEC 60601-1-2 and IEC 60601-1-3 by: 20125007 Replace IEC 60601-1-2 and IREeCqu6i0re6m01e-n1t-s3abnyd: tests IIEECC 6600660011 11 22 22001047 MMeeddiiccaall eelleeccttrriiccaall eeqquuiippmmeenntt ENE6N06600610-11 21-2 220001807 I(EmCod6)0601-1-32 20087 MPPaaerrdtti1c1-a-22l ::eGGleeecntnreeicrraaalll rereeqqquuuipiirrmeemmeneetnn-ttss ffoorr bbaassiicc E+Nco6r0r.6M01a-r1c-h32 2010 (mod) Pssaaaffreettt1yy-a23an:ndGd eeesnssesereannlttiriaaellqppueeirrreffoomrrmmenaatnsnccfeoer bCaoslliacteral + corr March ssCataofnelladtytaearrdna:dlEselteascsntedronamtridaa:l gEpneleercftoitcrromcmoamangcpneaet-itbiCciloitlyla-teral 2008 SRsdttieasaqntnuuddriabraerardmdn::ceERenlseatscd-tiaraRonteimdoqnatuegipsrnertoesmteieccncttiosmnanpindadttibieaislgittnsyo-stic 200228001008 XR-erqauyireeqmuiepnmtseannt d tests 20120010 IEC 60601-1-3 2008 Medical electrical equipment - EN 60601-1-3 IAEdCd6: 0601-1-3 22000088 MPMaeerddt ii1cc-aa3ll:eeGlleeeccnttrreiiccraaalll ereeqqquuuiipiprmemmeenentnt -t-s for basic EN+E6Nc0o66r0r0.61M0-11a r31c-h3 2005 MsPPaaeafredrttti1cy1a a33l n:e: dGlGeeecesntnrseiecerraanalltlierareeqlqqupuuiepiirrrmefeommermneetnan-tntssXcf-efoorar-rybCbataousslbliiaccetera+l c+ocrro.rMr aMrcahrch 2013 IEC 60336 2005 EN 60336 2014 +A1 2013 aSssasatasffeneettdmyyabaarnldnie:ddsReefasosdssreieamnntitetoiiadanlilcpppaerelorrdftfoeoiarcrmgmtinoaaonnnscicinseed -iCagonlloastetirca+l A1 CXSCt-hoaralnlraydataecertqedaur:lipsRStmtaicadesninadottafiorfdon:cpRarlaosdtepiacottison pinrodtieacgtnioonstiinc+A1/AC 2010 Xd-iaragynoesqtuicipXm-reanyt equipment 2005 IAEdCd6: 0613 2010 Electrical and loading characteristics of X-ray EN 60613 2005 Add: followin2g00r5eferMteuenbdceiecaa:slseelmecbtrliiecsalfoerqumipemdiecanlt d- iXag-rnaoystiusbe - EN 60336 2008 IDEeCle6t0e33th6e 200180 IEC 60336 2005 MaMseesddeiimccaabllleiellseeccftotrrriiccmaalel eedqqicuuaiiplpmdmiaeengntnt -o-sXGis-lroa-systaurbyeof EN 60336 2010 IEC/TR 60788 2004 - - 2007 CadEsehvsfaaienrlmuaeacdbtteiltoieernisrsmtafiocnssrdmorofeufdotiiccnaaell tsdepisaotgtinsngosinism- edical EN 61223-3-2 - IEC 61223-3-2 Cimhaagraincgtedriesptiacsrtmofefnotcsa-l spots 2008 20078 IEC 61026213-3-2 200170 EvleaclutraictaiolnanadndloraoduitningectheasrtaincgteirnismticesdiocfaXl -ray EN 60162123-3-2 IEC 60613 2010 EtiPmulabearectgt3irani-scg2sa:edlAmaecnpbcdaleireltpomstaaefdnonicrntesmg -tceehdsaitcsraa-lcIdtmeiaraigsgntinocgssisof X-ray EN 60613 2007 tpuebrefoarmssaenmcebloiefsmfoarmmmeodgicrapl hdicagXn-orasyis 2- 007 IEC/TR 60788 2004 MPeqaeurdtipi3cm-a2le:enAltecccteripcatalnecqeuitpemstsen-tIm- Galgoisnsgary of - IEC/TR 60788 2004 Mdpeeefrdifnoicermadlateenlrecmcetsroicf aml aemqumipomgreanpth-icGXlo-srasayry of - - deeqfuinipemdetenrtms - IEC 61223-3-2 2007 Evaluation and routine testing in medical EN 61223-3-2 IEC 6212203-13-2 2007 EMimveaadgluicinaagtlioednleepacantrrditcmraoleuentqtinsuei-ptmesetnintg- iCnhmareadcictearlistics EN 6212203-13-2 oPimfaadrtgig3ini-tag2l:dXAe-cprcaeyrptmimtaenancgtesint-gesdtesv-icIemsa-ging Ppearrfto13rm-2a: nDAcceecteeorpfmtmainaacmteiomtneosogtfrsath-pehImicdaeXgte-inrcagtyive qepuqeaurfnioptrmummeannetcffeicoiefnmcyam- DmeotgercatpohrsicuXs-erainy meqaumipmmoegnrtaphy IEC 62220-1-2 2007 Medical electrical equipment - Characteristics EN 62220-1-2 ISEOC 69223260-3-1-2 21090979 MPofhedoditgiocigatarlaleXpleh-rcyatry-icSiamelanegsqiiutnoigpmmdeeetrvnyictoe-fsCs-hcareraecnt/efirlmistics -EN 62220-1-2 sPoyfasdrttieg1mi-ta2sl: fXDo-reratmeyremidmiicnaaagltiinroagnddiooefgvtrhiacepehsdye-t-ective Pquaartn31tu-:2mD: eDetfefirtcmeireimnnacintyiao-tniDooneftoesfcettnhoseristdouemsteectirtniicvecurve smqhuaampnetmu,mosgpreeafefpidchiyeancdya-vDereatgeectogrsaduiseentinfor mammography ISO 9236-3 1999 Photography - Sensitometry of screen/film - ISO 9236-3 1999 Psyhsotteomgrsafpohrym-eSdeicnaslitroamdieotgrryaopfhsyc-reen/film - Psyasrtte3m: sDefoter rmmeindaictaiolnraodfiosegnraspithoym-etric curve sPhaartp3e:, Dspeeteerdmainnadtiaovneoraf gseengsriatodmieenttrficorcurve mshaampem,osgpreaepdhyand average gradient for mammography – – BS EN 60601-2-45:2011+A1:2015 - - EN 60B6S01E-2N-4650:62011-2+-A451:20115 EN 60601-2-45:2011 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 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 60601-2-45:2011+A1:2015 – – EN 60601-2-45:2011+A1:2015 – – BS EN 60601-2-45:2011 60601-2-45 IEC:2011 CONTENTS INTRODUCTION 67 201.1 Scope, object and related standards 78 201.2 Normative references .1.90 201.3 Terms and definitions 1101 201.4 General requirements 112 201.5 General requirements for testing of ME EQUIPMENT 123 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 123 201.7 ME EQUIPMENT identification, marking and documents 124 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 168 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 1291 201.10 Protection against unwanted and excessive radiation HAZARDS .213 201.11 Protection against excessive temperatures and other HAZARDS .223 201.12 Accuracy of controls and instruments and protection against hazardous outputs 223 201.13 Hazardous situations and fault conditions 224 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 224 201.15 Construction of ME EQUIPMENT 224 201.16 ME SYSTEMS 224 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 234 202 Electromagnetic compatibility – Requirements and tests 234 203 Radiation protection in diagnostic X-ray equipment 235 Annex AA (informative) Particular guidance and rationale 468 Bibliography 4580 Index of defined terms used in this particular standard 4591 Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements 112 Table 203.101 – Minimum values of TOTAL FILTRATION and factors for determining the minimum AIR KERMA RATE 3480 – – BS EN 60601-2-45:2011+A1:2015 – – EN 60601-2-45:2011+A1:2015 BS EN 60601-2-45:2011 60601-2-45 IEC:2011 INTRODUCTION The third edition of this particular standard has been prepared to provide a complete set of safety requirements for MAMMOGRAPHIC X-RAY EQUIPMENT, based on IEC 60601-1:2005 (3rd edition) and its collaterals This particular standard addresses the system level of MAMMOGRAPHIC X-RAY EQUIPMENT, which consists of a combination of an X-RAY GENERATOR, associated equipment and ACCESSORIES Components functions are addressed as far as necessary The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of MAMMOGRAPHIC X-RAY EQUIPMENT Like the previous edition of this Part 2-45, the present third edition includes requirements on HIGH-VOLTAGE GENERATORS for mammography BS EN 60601-2-45:2011+A1:2015 BBESSN EE60NN666000166-200-114 522: 2440551::122+0011A111:2015 – – B60S6E0N1-620-46501-2-I4E5C:2:2001111 – – B60S6E0N1-620-46501-2-I4E5C:2:200111 – – 60601-2-45 IEC:2011 – – 60601-2-45 IEC:2011MEDICAL ELECTR– I7C–AL EQUIPMENT – MEDICAL ELECTRICAL EQUIPMENT – MEDICAL ELECTRICAL EQUIPMENT – Part 2-45: ParticMuElaDrICreAqLuEirLeEmCeTnRtsICfoArLthEeQbUaIPsMicEsNaTfe–ty and essential Part 2-45: Particular requirements for the basic safety and essential Part 2-45:pPearrftoircmulaanrcreeqouf imreammemntosgfroarpthhice Xba-rsaiyc esqaufeiptymaenndt essential Part 2-45:ppPeearrrffatooinrrcmmdulaamannraccrmeeeqmoouffoimmgreraamammpehmmnitoocsggsfrrtoaaerpprethhhoiiccetaXXbca trrisaaciyycdeeseqqavuuficeiippetysmmaeennndtt essential perfaonrmd amnacme mofomgraamphmiocgsrtaeprehoictaXc-triacydeeqvuiciepsment and mammographic stereotactic devices and mammographic stereotactic devices 201.1 Scope, object and related standards 201.1 Scope, object and related standards 201.1 Scope, object and related standards C20la1u.s1e 1Socf othpeeg, eonbejreacl tstaannddarredl1a) taepdplsietsa,nedxacerdptsas follows: Clause of the general standard 1) applies, except as follows: Clause of the general standard 1) applies, except as follows: 2C0la1u.1s.e1 oSfctohpeegeneral standard 1) applies, except as follows: 201.1.1 Scope 201.1.1 Scope R20e1p.l1a.c1emSecnot:pe Replacement: Replacement: TRheipslaicnnettemrrennnaattt:iioonnaall ssttaannddaarrdd aapppplileiess toto ththee BAbSaIsCicSAsFaEfTeYtyanadndESSeEsNsTeInAtLiaPlERpFeOrRfMoArNmCaEncoef This international standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of oMTfhAiMsMmOianGmteRmrAnoPagHtriIoCanpXahl-iRcsAtYanEXdQ-aUrrIadPyMaEpNpeTlqieausnipdmtoeMnAtthMeMO BGARSiAnICPcHluSICdAiFnSEgTTEYREeaOqnTudAipCEmTSIeCSnEtDNETVIfAIoCLrESP,EmRhaFemOrmeRaMofAgteNrrCaEpahlsoiocf MAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES, hereafter also tMrTeohAfmieMsroMrseOinydGtneRttorAnhPaeHstsiIoCiMsnE XalE-RQsAaUtYnaIPdnEMdQmEaUNarIdTmP.mMaEopNgpTrliaeapsnhditcoMsAtthMeeMrOeBGoARtSAaICPcHtSIiCcAFSdETeTEvYRicEaeOnsTd,AChETeSIrCSeEaDNfEtTeVIrAICLaElSsPo,ERhrFeeOfreeRraMrfeAtedNrCtEoalsaoosf referred to as ME EQUIPMENT mrMeAefeMerMrqeOudGipRtmoAePanHstICM EXE-RQAUYIPEMQEUNITP.MENT and MAMMOGRAPHIC STEREOTACTIC DEVICES, hereafter also NreOfTeErre1d tTohias sinMclEudEeQs UMIPAMMMEONGTR APHIC X-RAY EQUIPMENT using integrated digital X-RAY IMAGE RECEPTORS or NinOteTgErat1ed TsthoirsaginecpluhdoessphMoAr MsMubOsGyRsAtePmHIsC X-RAY EQUIPMENT using integrated digital X-RAY IMAGE RECEPTORS or NinOteTgErat1ed TsthoirsaginecpluhdoessphMoAr MsMubOsGyRsAtePmHIsC X-RAY EQUIPMENT using integrated digital X-RAY IMAGE RECEPTORS or iNnOteTgErat1ed TsthoirsaginecpluhdoessphMoAr MsMubOsGyRsAtePmHIsC X-RAY EQUIPMENT using integrated digital X-RAY IMAGE RECEPTORS or Einxtecglruadteeddstforroamge tphheosspchoopr esuobsf ytshteismds.ocument are: Excluded from the scope of this document are: Excluded from the scope of this document are: –Exclruedceodnsftrroumctitvhee tsocmoopgeroafphthyismdoodceusmoefnotpaerrea:tion; –– reconstructive tomography modoethseorfthoapnermataiomnm;ographic tomosynthesis; – rdeiacgonosstrtuicctcivoenstomleosg; raphy modes of operation; –– drceitacgosncosastnrtuniccetrcivosencstoovmleosre;gdrabpyhyIEmCo6d0e6s0o1f-2o-p4e4r;a tion; – pdicatgunroesatircchciovninsgolaensd; communication systems (PACS); – pdicatgunroesatircchciovninsgolaensd; communication systems (PACS); – pnoicntu-irneteagrrcahtievdinsgtoarnadgecopmhmosupnhicoar trioeandseyrsst;ems (PACS); – npoicntu-irneteagrrcahtievdinsgtoarnadgecopmhmosupnhicoar trioeandseyrsst;ems (PACS); – nhoarnd-incotepgyractaemd esrtaosra; ge phosphor readers; – hnaornd-incotepgyractaemd esrtaosra; ge phosphor readers; – hfilamrds,csocpryeecnasmaenradsc; assettes; – fhilamrds,csocpryeecnasmaenradsc; assettes; – fciolmmsp,ustcerreaeindsedanddetceacstisoentt(eCsA; D); – cfiolmmsp,ustcerreaeindsedanddetceacstisoentt(eCsA; D); – cdoemvicpeustefroar ipderdfodremteincgtiocnor(eCbAiDop);sy and other biopsy instruments; – dcoemvicpeustefroar ipderdfodremteincgtiocnor(eCbAiDop);sy and other biopsy instruments; – mdeovdiceess ofof r oppeerfroartmioinnginctoernedbeidoptsoy daenmd onthsetrrabteioploscyailnsctorunmtreansts;medium uptake (contrast – emdneohvdiacenescseofdof rdopigpeietrafroal rtmmioaninmgimnctooegrnerdabepidhoyp)tso; y daenmd onthsetrrabteioploscyailnsctorunmtreansts;medium uptake (contrast – menohdaensceodf doigpietaral tmioanmimntoegnrdaepdhy)to; demonstrate local contrast medium uptake (contrast – emnohdaensceodf doigpietaral tmioanmimntoegnrdaepdhy)to; demonstrate local contrast medium uptake (contrast If a ecnlahuasneceodr dsiugbitcallamusaemims osgpreacpifhicya);lly intended to be applicable to ME EQUIPMENT only, or to If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to IMf EaScYlSaTuEsMeSoor nsluy,bcthlaeutsiteleisansdpeccoinfitceanlltyoifnttheantdceldautoseboer aspupblciclaaubslee twoilMl sEaEyQsUoIP MIfEtNhTatoinslyn,oot rthteo ME SYSTEMS only, the title and content of that clause or subclause will say so If that is not the IcMfaEasSecY,lSathTueEsMecSlaoour nssleuy,boctrhlsaeutbsitcelelaisuasnsedpeaccpoipnfiltcieeanslltybooifntththeatnotdcMeldEauEtosQeUboIePrMasEpuNpbTlciclaaanubdsleetotwoMilEMl sESaYEySQTsUEoIMP MSIf,EtaNhsTatroeinslelynv,oaotnrtt.hteo case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant cMaEsSeY, SthTeEMcSlaounsley,otrhseutbitclelauasned acpopnltieenst boof tthhatot cMlEauEsQeUoIPrMsEuNbTclaanudsetowMilEl sSaYySTsEoM SIf, tahsatreislenvoatntt.he NcaOsTeE, 2theIEcCla6u06s0e1-o2r-7s:1u9b9c8laaundseIEaCp6p0l6ie0s1-2b-o3t2hatroe rd aednidtiotnosMchEemSYe SfoTrEMMASM,MaOsGRrAePleHIvCaXn-tR.AY nMoEt pEaQrtUoIfPtMhEe N3Trd NEQOUTIPEM2ENTIEaCnd60M6A0M1M-2O-G7R:1A9P9H8ICaSnTdERIEECOT6A0C6T0IC1-D2E-V3I2CEaSre not part of the 3rd edition scheme for MAMMOGRAPHIC X-RAY NEQOUTIPEM2ENTIEaCnd60M6A0M1M-2O-G7R:1A9P9H8ICaSnTdERIEECOT6A0C6T0IC1-D2E-V3I2CEaSre not part of the edition scheme for MAMMOGRAPHIC X-RAY ENQOUTIPEM2ENTIEaCnd60M6A0M1M-2O-G7R:1A9P9H8ICaSnTdERIEECOT6A0C6T0IC1-D2E-V3I2CEaSre not part of the 3rd edition scheme for MAMMOGRAPHIC X-RAY 2EQ0U1IP.1M.E2NT aOnbd jMeAcMtMOGRAPHIC STEREOTACTIC DEVICES 201.1.2 Object 201.1.2 Object R20e1p.l1a.c2emOenbtj:ect Replacement: Replacement: TRheeplaocbejemcet notf: this particular standard is to establish particular BASIC SAFETY and ESSENTIAL The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PTEhReFOobRjMeAcNt CoEf threisqupiarertmiceunlatsr stfaonr daMrdAMisMOtoGReAsPtHaIbClishX-pRaArYticuElQaUr IPBMASEINCT SAaFnEdTY MaAnMdMEOSGSREANPTHIAICL PERFORMANCE requirements for MAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC PSTEThEReRFOEoObRjTMeAAcCNtTCoICEf tDhrEeisVqICupEiarSert,micteuonlatesrnstfuaornredasMardAfeMitsMy,OtoGtoReAssPptHaeIbcCliifsyhXm-pReaAtrYhtiocduEslQaUrfoIPBrMAdSEeINCmT SoAnaFsnEtdrTaYtiMnagAnMdcMoEOmSGSpRElAiNaPTnHIcAICeL STEREOTACTIC DEVICES, to ensure safety, to specify methods for demonstrating compliance wSPTEitERhRFtEOhORoTMsAAeCNrTCeICEquDirEeVqmICueEirnSet,smtaeondtesntosfuporreovsMiadAfeeMtgMyu,OidGtoaRnAscPpeHeIfcCoirfyRXIm-SRKeAtMYhAoNdEAsQGUfEoIPMrMEdENeNTm.T onasntdratiMngAMcMoOmGpRlAiaPnHcICe with those requirements and to provide guidance for RISK MANAGEMENT wSTitEhRtEhOoTsAeCrTeICquDirEeVmICeEnSt,s taondentosuprreovsiadfeetgyu,idtoanscpeefcoirfyRImSKetMhAoNdAsGfEoMr EdNeTm onstrating compliance _w_it_h th o_s_e requirements and to provide guidance for RISK MANAGEMENT _ _1) T_h_e g_e_n_e_ral standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for 1) _bT_ah_se_ic_g_se_an_fee_rtayl asntdanedsasredntisialIEpCerf6o0r6m0a1n-c1e:2 005, Medical electrical equipment – Part 1: General requirements for 1) Tbahseicggesenanefeerratayllsatsnatdandneadsrasdredisnti sialIEIpECeCrf66o00r6m600a11n c11e::2.200005,aMndedIEicCal60e6le0c1t-r1ic:2a0l 0e5q/uAiMpmDe1n:2t0–12Part, M1:edGiceanleerlaelctrreicqauliereqmuiepnmtsenfto–r 1) bTPahasertic1gs:eanGfeertnayel rasantldarneedqsausrierdenmtisiaelnIEptseCrffo6or0rbm6a0as1ni-cc1e:s2.a0fe0t5y, aMndedeicsasel netlieacl tpreicrafol remqaunipcem.ent – Part 1: General requirements for basic safety and essential performance