Bsi bs en 60601 2 44 2009 + a1 2012

BS EN 60601-2-44:2009+A1:2012 BSI Standards Publication Medical electrical equipment Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography BS EN 60601-2-44:2009+A1:2012 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN 60601-2-44:2009+A1:2012 It is identical to IEC 60601-2-44:2009, incorporating amendment 1:2012 It supersedes BS EN 60601-2-44:2009+A11:2011 which will be withdrawn on October 2015 The start and finish of text introduced or altered by amendment is indicated in the text by tags Tags indicating changes to IEC text carry the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 2013 Published by BSI Standards Limited 2013 ISBN 978 580 71996 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 July 2009 Amendments/corrigenda issued since publication Date Text affected 31 March 2012 Implementation of CENELEC amendment A11:2012: Annex ZZ replaced Implementation of IEC amendment 1:2012 with CENELEC endorsement A1:2012 EUROPEAN STANDARD EN 60601-2-44:2009+A1 NORME EUROPÉENNE EUROPÄISCHE NORM October 20112 Supersedes EN 60601-2-44:2009 ICS 11.040.50 English version Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (IEC 60601-2-44:2009) Appareils electromédicaux - Medizinische elektrische Geräte - Partie 2-44: Exigences particulières Teil 2-44: Besondere Festlegungen pour la sécurité de base für die Sicherheit einschließlich et les performances essentielles der wesentlichen Leistungsmerkmale des équipements rayonnement X von Röntgeneinrichtungen de tomodensitométrie für die Computertomographie (CEI 60601-2-44:2009) (IEC 60601-2-44:2009) This European Standard was approved by CENELEC on 2009-05-01 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, 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 Central Secretariat: Avenue Marnix 17, B - 1000 Brussels © 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members Ref No EN 60601-2-44:2009 E BS EN 60601-2-44:2009+A1:2012 – – EBNS 6E0N60610-26-0414-:20-4049:+2A010:920+1A21(1E:)2011 – – EN 60601-2-44:2009+A11:2011 (E) Foreword The text of document 62B/727/FDIS, future edition of IEC 60601-2-44, 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 60601-2-44 on 2009-05-01 This European Standard supersedes EN 60601-2-44:2001 + A1:2003 EN 60601-2-44:2009 constitutes a technical revision primarily related to RADIATION protection and control The following dates were fixed: – latest date by which the EN has to be implemented (dop) 2010-02-01 at national level by publication of an identical national standard or by endorsement – latest date by which the national standards conflicting (dow) 2012-05-01 with the EN have to be withdrawn 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 (93/42/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 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 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 Annexes ZA and ZZ have been added by CENELEC BS EN 60601-2-44:2009+A1:2012 BS EN 60601-2-44:2009+A11:2011 – – BS EENN66006601 22 4444::22000099++AA1:1210:1220(1E1) – – EN 60601-2-44:2009+A11:2011 (E) EN 60601-2-44:2009+A11:2011 (E) – – Endorsement notice Endorsement notice The text of the International Standard IEC 60601-2-44:2009 was approved by CENELEC as a European TShtaendteaxrtdowf itthheouInt taenrynamtioodniafilcSattiaonnd.ard IEC 60601-2-44:2009 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: In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60601-2-7 NOTE Harmonized as EN 60601-2-7:1998 (not modified) IEC 60601-2-7 NOTE Harmonized as EN 60601-2-7:1998 (not modified) IEC 60601-2-32 NOTE Harmonized as EN 60601-2-32:1994 (not modified) IEC 60601-2-32 NOTE Harmonized as EN 60601-2-32:1994 (not modified) IEC 60613 NOTE Harmonized as EN 60613:1990 (not modified) IEC 60613 NOTE Harmonized as EN 60613:1990 (not modified) Foreword to amendment A11 Foreword to amendment A11 This document (EN 60601-2-44:2009/A11:2011) has been prepared by CLC/TC 62 “Electrical equipment Tinhmiseddoiccaulmperanct t(icEeN”.60601-2-44:2009/A11:2011) has been prepared by CLC/TC 62 “Electrical equipment in medical practice” The following dates are fixed: The following dates are fixed: (dop) 2012-10-01 (dop) 2012-10-01 • latest date by which this document has • tlaotebset idmaptelembyewntheidchatthnisatdiooncaulmleevnetl hbays tpoubbeliciamtipolnemofeannteiddeant tnicaatilonnaatliolenvael l by pstuabnlidcaartdioonrobfyaenniddeornstiecmalennat tional standard or by endorsement • latest date by which the national (dow) 2014-10-01 • slattaensdtadradtsecboynwflihcitcinhgthweithnathtiiosnal (dow) 2014-10-01 sdtoacnudmarednst choanvfelictotinbgewwitithhdthriaswn document have to be withdrawn AEtNte6n0tio6n01i-s2-d4r4a:w2n00t9o/Ath1e:2p0o1s2sibility that some o-f 2th-e elements of this document may be the subject of ApEatNttee6nn0ttio6rn0ig1hi-st2s-d.4rC4a:Ew2Nn00Et9oL/EAthC1e:2[ap0no1ds2/soibr iClitEyNth] asthsaollmneot ob-fe2thh-eeldeleremsepnotnssiobflethfiosr didoecnutmifyeinntgmanayy obreatlhl esuscuhbjpeacttenotf priagthetsn.t rights CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights Foreword ForewordFtooreawmoernddment A1 The text of document 62B/869/FDIS, future amendment to edition of IEC 60601-2-44, prepared by SThCe6t2eBxt "oDf idaogcnuomsteicnitm6a2gBi/n8g69e/qFuDipISm,efnut"uroef aIEmCenTdCm6e2nt"E1letocteridciatiloenq3uiopfmIEenCt 6in06m0e1d-2ic-a4l4p, rparcetpicaer"edwbasy sSuCbm62itBted"DiagtonosttihceimagIEinCg-CeEquNipEmLEeCnt" ofpaIEraClleTlC 6v2o"teElectarnicdal eqaupipprmoveendt in mbyedicCalEpNrEacLtEicCe" was EsuNbm60it6te0d1-2-4to4:20t0h9e/A1:I2E0C1-2C.ENELEC parallel vote and approved by CENELEC as EN 60601-2-44:2009/A1:2012 The following dates are fixed: The following dates are fixed: • latest date by which the document has (dop) 2013-07-04 • tlaotebset idmaptelembyewntheidchathneatdioncaulmleevnetlhbays (dop) 2013-07-04 ptoubeliciamtipolnemofeannteiddeant tnicaatilonnaatliolenvael l by sptuabnlidcaartdioonrobfyaennidoernstiecmalennat tional standard or by endorsement • latest date by which the national (dow) 2015-10-04 • slattaensdtadradtsecboynwflihcitcinhgthweithnathtieonal (dow) 2015-10-04 dstoacnudmarednst choanvfelictotinbgewwiitthhdthreawn document have to be withdrawn Attention is drawn to the possibility that some of the elements of this document may be the subject of pAattteennttiornigihstsd.raCwEnNtEoLtEheC p[oasnsdi/boirlityCEthNa]t sohmalel nooftthbee ehleemldernetspoofntshiibsledofcour mideennttimfyainygbaentyheorsuablljescutcohf patent rriigghhttss 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 aTnhdistdhoecEuumroepnet ahnasFbreeeenTrpardeepaArsesdoucniadteiorna, amnadnsduaptepogritvseenstsoeCntEiaNl EreLqEuCirebmyethnetsEouf rEoUpeDanireCcotimvem(si)s.sion and the European Free Trade Association, and supports essential requirements of EU Directive(s) Endorsement notice Endorsement notice The text of the International Standard IEC 60601-2-44:2009/A1:2012 was approved by CENELEC as aThEeurteoxpteoafntShetaInndtearndawtiiothnoaul tSatannydmaorddiIfEicCati6o0n6 01-2-44:2009/A1:2012 was approved by CENELEC as a European Standard without any modification BS EN 60601-2-44:2009+A1:2012 – – EBNS 6E0N60610-26-0414-:20-4049:+2A010:920+1A21(1E:)2011 – – EN 60601-2-44:2009+A11:2011 (E) Annex ZA (normative) BS EN 60601-2-44:2009+A11:2011 EN 60601-2-44:2009/A1:2012 - - EN 60601-2-44:20N09o+rAm1a1t:i2v0e11re(fEe)rences –to4 i–nternational publications with their corresponding European publications Annex ZA Annex ZA The following referenced documents are ind(ni(sonproemnrmsaatabivtleiev)efo)r the application of this document For dated references, only the edition cited applies For undated references, the latest edition of the referenced document (includinNgNoanorymramamtaeitvnievdmereernfeetfsre)eranepnpcleciesess.totoinintetrenrnataitoionnalapl puubblicliactaitoionnss NOTE When an internatwiowniatihl tphutbhtlihecaietrioirncohcaorsrrbereseenpspomoondndifiedindingbygEcoEumurmoroopn pemaeodnaifnicpaputioubnsbl,icliniacditaciatotieond nsbys(mod), the relevant EN/HD applies TThhee ffoolllloowwiinngg rdeofceuremnecnetds,dioncuwmhoelnetsorarine pinadrits,paernesanbolremfaotrivethlye raepfeprliecnactieodn ionf tthhisis ddooccuummeenntt.aFndor adraeted ArinendfenisreepxneZcneAssao,bfloeEnNlfyo6rt0hite6s0e1ad-p1ipt:io2licn0a0tc6ioitaenpd pFalioeprsp,ldieasxte.cedFporterafues-nrfe3donall-coteewdss,:roenfelyretnhceese,dtihtieonlactEeitNsetd6e0ad6pi0tpio1lin-e2s-o.4f4Ft:oh2re00ur9en/fdAear1tee:2nd0ce1d2 dreofceuremnecnets(,inthceluldaitnegstaendyitaiomneonfdtmheenretsfe) raepnpcleieds.document (including any amendments) applies Publication Year Title EN/HD Year NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD NOTE When an international publication has been moAdinfiendebxy cZomAmon modifications, indicated by (mod), the relevant EN/HD Rapepplielas.ce the reference to IEC 60601-1-3 by: applies 2008 Medical electric(naloerqmuaiptmiveen)t - IEC 60601-1-3 EN 60601-1-3 2008 APnunbelicxaZtiAonof EN 606Y01e-a1r:200T6Pitlaeprtp1li-e3s:,Geexcneprat larseqfoulilroewmse: nts for basic EN/HD Year Normativseafreetyfearnednecsseesnttiaol pinertfeormnanticoen-aClopllautebrlaicl ations PInubAlincanteioxn ZA of EwNYiet6ah0r 6th0e1Tsi-itrt2alenc-4doa4rr:rd2e:0sR0pa9do,ianatdidoindnpguronEtdeucertriooRnpeienpadnliaacgpneuombstleiiccnattEtihoNen/HsfDollowing newYear Rreefpelraecnecthee: reference to IEC X60-r6a0y1e-1q-u3ipbmye: nt AITIEEhdCCed6i6fto00iol66lon00w:11i n11g 32docum22e00n00t7s8, inMMwehedodiclieacal oel releliecntcrptircaiacralt,el eqaqureuipipmnmoerenmntat-t-ively referenceEdNin60th6i0s1d-1o-c2ument 2a0n0d72a0r0e8 i(nmdoisdp)ensable for EN 60601-1-3 IEC 60601-1 its 2a0p0p5licaPtMiPoaaenrtrd.t1iFc1-2ao-3:lr:eGdGleeaecntetnerdeircaraalrelrleefreeqqrquueuiinrpiecrmememesen,entonts-ntsflyofortrbhbaeasiescidcition+ccEitoeNrdr.6Ma0p6ap0rlc1ieh-1s For 2u0n1d0ated references, the latest edition soPasfaftehrfetteyt1yra:eanGfndeedreneesnssrcaeselendrnteidatqioalucpliuperemerfmroeforenmrntmta(siannfnccoeclrue-bd-aiCnsCogicollaalslnataeytfreeaartlamyl endments) applies 2006 NOTE When an international publicsaatstanitoandnndhedaasarsdsrbd:ee:EneRtlnieaamcldtopridoaeimftriiefooadnrgbmpnyarecontoitmcceemcctooionmnmpioandtiidfbiciiaalitgtioynno-s,sitnicdicated by (mod), the relevant EN/HD applies RXe-qruaiyreemqueinptms eanntd tests IEC 61223-3-5 2004 Evaluation and routine testing in medical EN 61223-3-5 2004 AInddAintinone:x ZA of EN 60601im-2a-g4in4g:2de0p0a9rt,maedndts u- nder Addition the following new Publication Year TPitalert 3-5: Acceptance tests - Imaging EN/HD Year reference: IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006 Ppearrfto1rm: Gaennceeroafl creoqmupiruetmedentotsmfoogr rbaapshicy Xsa-rfaeyty IEnCA6n0n3e3x6 ZA of E-N 6060M1ee-q2dui-icp4am4l e:e2nle0tc0tr9ic,aal edqduipumndenetr-RXe-rpaylatucbeemenEtNth6e03f3o6llowing ne-w reference: and essential performance 1) assemblies for medical diagnosis - IISEOC 6112202532-3-5 2- 004 CEHhveaaarlaluthcatteiinorfinsotraimcnsadotircfosfuo-tcinDaeligstieptasoltisinmgaigninmgeadnicdal E- N 61223-3-5 2- 004 IEC 60601-1-2 2007 Mcimeodmaigcmianulgnedilceeacpttiraoicrntamilneenmqtuseipd-miciennet (-DICOM) includinEgN 60601-1-2 2007 (mod) PPwaaortrrtk13f-l2o-5:w:GAaencndceedrpaatlatarnecmqeuaitnreeasmgtseem-ntIesmnfatogrinbgasic + corr March 2010 spaeferftoyramnadnecsesoefnctioaml ppeurtfeodrmtoamncoegr-aCphoyllaXte-rraayl setaqnudipamrde:nEtlectromagnetic compatibility - 1) Requirements and tests ISO 12052 - Health informatics - Digital imaging and - - In Annex ZA of EN 60601co-2m-m44un:2ic0a0tio9n, aindmdeduincidner(DAICdOdMiti)oinncltuhdeingfollowing new reference: workflow and data management IEC 60336 - Medical electrical equipment - X-ray tube EN 60336 - assemblies for medical diagnosis - Characteristics of focal spots 1) Undated reference – – BS EN 60601-2-44:2009+A1:2012 – – BS EENN66006601 22 4444::22000099++AA1:1210:1220(1E1) EN 60601-2-44:2009+A11:2011 (E) 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 except as follows: – Essential Requirement 6a – Essential Requirement 7.4 – Essential Requirement 7.5 paragraph & – Essential Requirement 13.6 (q) 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 60601-2-44:2009+A1:2012 – – BS EN 60601-2-44:2009+A11:2011 EN 60601-2-44:2009+A1:2012 (E) – – EN 60601-2-44:2009+A11:2011 (E) CONTENTS FFOORREEWWOORRDD�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.� �.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�22 201.1 Scope, object and related standards������������������������������������������������������������������������7 201.1 Scope, object and related standards 201.2 Normative references ���������������������������������������������������������������������������������������������9 201.2 Normative references 201.3 Terms and definitions �������������������������������������������������������������������������������������������� 10 201.3 Terms and definitions 201.4 General requirements 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umnewcahnatneidcaalnHdAeZAxcReDsSsoivfeMrEaEdQiaUtIiPoMnEhNaTzaanrddsM�E���S�Y��S��T��E��M��S��.�.�.�.�.�.�.�.�.�.�.�.�2217 201.110 Protection against euxncweasnstieved taenmdpeexrcaetusrseivseanRdADoIAthTeIOr NhaHzAaZrAdRsDS��.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�247 220011 1121 PArcoctuercatcioynoaf gcaoinntsrot lesxacnedssinivsetrtuemmepnetrsaatunrdespraontedcotitohneraHgaAZinAsRtDhSa.z a r.d o u s o u t.p u t.s .�.�.�.�2247 AHcaczuarradcoyusofscitounattrioonlss aanndd ifnasutrltucmoenndtistioannsd��p��r�o��t�e��c�t�i�o��n���a��g��a��in��s��t��h��a��z��a��r�d��o��u�s������������������ 28 220011 1132 oPurtopgurtsa.m m a b l e e l e c t.r i.c a l m e.d i.c a l s.y s t e.m s (.p e.m s.) �.�.�.�.� �.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.� 2248 201.14 201.153 HCaonzastrrduocutisonsitoufamtieonesquainpdmefanutl�t��c�o��n��d��i�t�i�o��n��s��.�.�.� �.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�258 220011 1164 PMReOsGyRsAtMeMmAsB�L��E���E�L��E��C��T�R��I�C��A��L��M���E��D�I�C��A��L���S�Y��S��T��E��M��S���(�P��E��M��S��)�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�2258 220011 1175 CEloencsttrruocmtiaognnoeftMicE cEoQmUpIPaMtiEbNilTit.y o f m e e q u i.p m e n t a n d m e s y s.t e m s .�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�2259 220011 11061 MReEqSuYirSeTmEMenSt.s f.o r C T s.c a n n e r s p r.o v.i.d i.n g im a g e s f.o r r a d.i.o t h e r a p.y 25 treatment planning 29 201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS 26 202 Electromagnetic compatibility – Requirements and tests 34 220033 GGeenneerraall rreeqquuiirreemmeennttss ffoorr rRaAdDiIaAtTiIoOnN pprrootteeccttioionnininddiaiaggnnoosstitcicXX rraayyeeqquuipipmmeennt t�.�.�.�.�.�.�.�2365 AAnnnneexxeess�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.� �.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�4500 AAnnnneexx AA ((iinnffoorrmmaattiivvee))  CChhoooossiningglLoOaAdDinINgGfFaAcCtToOrRsSfofor rtetesststs��.� �.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�4511 Annex B (informative)  EEssttiimmaattiinngg CCTTDDIIvvool lfofor rscsacnanprporjoejcetciotinonraRdAiDoIgOrGaRpAhPyHY(S(PSRPR) �)�.�.�.�.�.�.�.�.�.�.�.�.�.�.�452 BAinbnlieoxgrCaCph(yin f.o r.m a.t.i.v e ).  T h e C T D I.1 0 c o n c.e p t i.n I.E C 6 -.2 -.4 : R e l.a t.i.o n s.h i.p b e t.w e e n 43 CTDI100 and CTDI∞ 53 Index of defined terms used in this particular standard 44 Annex DD (informative)  Measuring CTDIfree air 57 Bibliography�������������������������������������������������������������������������������������������������������������������������� 59 Figure 201.101 – Coordinate system 11 Index of defined terms used in this particular standard����������������������������������������������������������61 Figure 203.101 – Zone of extra-focal RADIATION 31 FFiigguurree 220013 110012 –– CMoinoirmdiunmatedismyesntesmion��s���f�o��r��S��T��R��A�Y���R��A��D��I�A��T�I�O��N���m���e��a��s��u�r��e��m��e��n��t�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�.�3141 Figure 201.102 – Illustration of N × T,R and (N × T) + R 14 TFiagbulree220031.1.10013−–TVeesrttipcaalttaelringnfomreCnTt oDfIftrheeepaaitri.e n t s.u p p o r t .3289 Figure 201.104 – Z-axis alignment of the patient support in the horizontal plane 30 Figure 203.101 – Zone of extra-focal radiation��������������������������������������������������������������������� 40 Figure 203.102 – Minimum dimensions for stray radiation measurement����������������������������� 43 Figure CC.1 – CTDIW versus beam width along Z 54 Table 203.101 − Test pattern for CTDIfree air�������������������������������������������������������������������������� 48 Table CC.1 – Ratios of CTDI by phantom length 56 BS EN 60601-2-44:2009+A11:2011 – 7––7 – BS EN 60601-2-44:2009+A1:2012 BENS 6E0N660016-20-14-42:-24040:290+0A91+1A:21011:210(1E1) EN 60601-2-44:2009+A1:2012 (E) EBNS 6E0N660016-20-14-42:-24040:290+0A91+1A:21011:210(1E1) – – EN 60601-2-44:2009+AM1E1:D20IC11A(LE)ELECTR– I7C–AL EQUIPMENT – MEDICAL ELECTRICAL EQUIPMENT – Part 2-44: Particular requirements for the basic safety and essential MEDICAL ELECTRICAL EQUIPMENT – Part p2e-4rf4o:rPmaarnticceuloafr Xre-rqauyireeqmueipnmtsefnotrftohrecboamspicutseadfettoymaongdraepshseyntial Part p2e-4rf4o:rPmaarnticceuloafr Xre-rqauyireeqmueipnmtsefnotrftohrecboamspicutseadfettoymaongdraepshseyntial performance of X-ray equipment for computed tomography 201.1 Scope, object and related standards 201.1 Scope, object and related standards Clause of the general standard1) applies, except as follows: 201.1 Scope, object and related standards Clause of the general standard1) applies, except as follows: 201.1.1 Scope Clause of the general standard applies, except as follows:1) 201.1.1 Scope Replacement: 2R0e1p.l1a.c1emenSt:cope This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CT Replacement: STChAisNNInEtReSrn, ahteiorenaaflteSrtaanlsdoarredfearprepdlietso atos tMhEe EBQAUSIIPCMSEANFTE TY and ESSENTIAL PERFORMANCE of CT SCANNERS, hereafter also referred to as ME EQUIPMENT This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CT If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to SCANNERS, hereafter also referred to as ME EQUIPMENT IMf EaScYlSaTuEsMeSoor nsluy,bcthlaeutsiteleisansdpeccoinfitceanlltyoifnttheantdceldautoseboer aspupblciclaaubslee twoilMl sEaEyQsUoIP MIfEtNhTatoinslyn,oot rthteo McaEsSeY, SthTeEMcSlaounsley,otrhseutbitclelauasned acpopnltieenst boof tthhatot cMlEauEsQeUoIPrMsEuNbTclaanudsetowMilEl sSaYySTsEoM SIf, tahsatreislenvoatntt.he If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant NMOETSEY1STESMeeSaolsnoly4,.2thofethtietlgeenaenrdal cstoanntdeanrdt 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 NOTE See also 4.2 of the general standard The scope of this document is limited to CT SCANNERS intended to be used for both head and bTNoOhdeTEys1ccohpSaeeraeocaftlestohrii4ss.e2ddoof bcthuyemageennnetEriaNslCslLtimaOnSidtUaerRddE.tooCf TthSeCXAN-rNaEyRSsoinutrecned(se)d atondbeimuasgeidngfodr ebtoetchtohre(sa)d iannad cboomdymcohnapraroctteecritsiveed cboyvearninENthCeLOsShUaRpEe ooff athetorXo-idra yIt sionuclrucdee(ss) saanfedtyimreaqguinirgemdeentetsctofor(rst)heinXa- RTAhYe GsEcoNpEeRAoTfOtRhSisudsoecduimn eCnTt iSsClAimNNiteEdRSt,oinCcTluSdCinAgNNthEoRsSeinwtehnedreedHItGoHb-VeOuLsTeAdGEfoGr EbNoEtRhAhTeOaRdS aanrde common protective cover in the shape of a toroid It includes safety requirements for the X- binotedgyractheadrawcitehriasnedX-bRyAYaTnUBEENCALSOSSEUMRBELY.of the X-ray source(s) and imaging detector(s) in a RAY GENERATORS used in CT SCANNERS, including those where HIGH-VOLTAGE GENERATORS are common protective cover in the shape of a toroid It includes safety requirements for the X- integrated with an X-RAY TUBE ASSEMBLY NRAOYTEG2ENERReqAuTiOreRmSenutss efodr iXn-RCAYTGSECNAERNANTEORRSS,anindcflourdAiSnSgOCthIAoTsEDe EwQUhIePrMeENHTI,GwHh-iVchOLwTeAreGpEreGvEioNuEsRlyAsTpOeRciSfieadrien iIEnCte6g0r6a0te1-d2-w7 itahndanIEXC-6R0A6Y01T-U2-B3E2,AShaSvEeMBbeLeYn included in either IEC 60601-1:2005 (Ed3) or this edition of NIEOCT6E06201R-2e-q4u4i.reTmheernetsfofroerIEXC-RA6Y06G0E1N-E2R-7ATaOnRdSIEaCnd60fo6r0A1S-2S-O3C2IAaTrEeDnEoQt UpIaPrMt EoNf Tth, ew3hricdhedwietiroen psrcehveiomueslfyorspCeOcMifPieUdTEiDn TIEOCMO6G0R6A0P1H-2Y-.7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or this edition of NIEOCT6E06201R-2e-q4u4i.reTmhernetsfofroerIEXC-RA6Y06G0E1N-E2R-7ATaOnRdSIEaCnd60fo6r0A1S-2S-O3C2IAaTrEeDnEoQt UpIaPrMt EoNf Tth, ew3hricdhedwietiroen psrcehveiomueslfyorspCeOcMifPieUdTEiDn TIEOCMO6G0R6A0P1H-2Y-.7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or this edition of 2I E0C1T6.1h06.e201s-c2o-4p4Oe bTojhefecrtehtfiosreInIEtCer6n0a6t0io1-n2a-7l Standard excludes radiotherapyrdsimulators and systems and IEC 60601-2-32 are not part of the edition scheme for COMPUTED TwOhMeOrGeRAthPHeYi.mage is created by a source other than an X-ray tube. 201.1.2 Object Replacement: R20e1p.l1a.c2emenOt:bject The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL Replacement: PTEhReFOobRjMeAcNt CoEf rtehqisuipreamrtiecnutlsarfosrtaCnTdSaCrdANisNEtRoSeasstadbelifsinhedpainrti2c0u1la.r3.B2A0S1I,CtoSAeFnEsTuYreasnadfeEtSy,SEaNnTdIAtoL PspEeRcFiOfyRMmAeNtChEodrseqfourirdeemmeonntsstfroartiCnTg ScoCmANpNliEaRnSceaswditehfitnheodseinre2q0u1i.r3e.m20e1n,tst,ofeornsCuTreSCsAaNfeNtEy,RSa.nd to The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL specify methods for demonstrating compliance with those requirements, for CT SCANNERS PNEORTFEO1RMRAeNqCuiErermeeqnutsirefomr ernetpsrofdourcCibTilitSy,CAliNneNaErRityS, acsondsetafinncey dainnd20ac1c.u3r.a2c0y1,arteo egnivseunrebescaafuestey, oaf ndthetoir rseplaetcioinfyshmipetothtohdesqufoalritydeamndoqnusatnratittyinogf cthoemIOpNlIiZaInNGceRAwDiItAhTIOthNopsreodruecqeduiarendmaernetsco, nffoinreCd TtoStChoAsNeNcEoRnSsi.dered NneOcTeEss1aryRfoerqusiarfeemtye.nts for reproducibility, linearity, constancy and accuracy are given because of their relationship to the quality and quantity of the IONIZING RADIATION produced and are confined to those considered NnNeOOcTTeEEss21aryBRfooetrqhusiatrhfeeemtylee.nvtesls ffoorr croemprpolidauncciebilaitnyd, tlhineetaersittys, prceosncsrtibaendcyto adnedteramcicnueraccoympaliraencgeivreenflecbtetchaeusfaect othf atthtehier relationship to the quality and quantity of the IONIZING RADIATION produced and are confined to those considered safety of HIGH-VOLTAGE GENERATORS is not sensitive to small differences in levels of performance The cNnoeOmcTebEsisn2aartyioBfnostrhsoatfhfeLtOyle.AvDeINlsGfoFrAcCoTmORpSlianscpeecaifnieddthfeortesthtse ptreesstcsribaered ttohedreetfeorrme inleimcitoemdpliinanncuemrebfeler cbt utht ecfhaocst etnhatfrtohme esaxpfeetryienocf e HIaGsH-bVeOiLnTgAGaEppGrEoNpEriRaAteTOiRnS misosnt oct asseesn.sitIitveis tocosnmsiadlel reddiffeimrepnocretasntintolesvtealsndaorfdipzeerfothremacnhcoei.ceThoef ccNooOmmTbbEiinn2aattiiooBnnossthooftfhLeOLOAleDAvIDNeIGNlsGFfAoFCrATcCOoTRmOSRpsSlioanstcpheeactaicfnioedmdtphfaeorritseosthntsecpatrenessbtcserimbaeraeddettohbederetewtfeoerremenintleiemscittosemdppelriinfaonrnmcueemdrebifenler dcbtifufteht reecnfhatocpstleatnhcaetfsrtoohmne desaixfpffeeetrryeienntocfoecHcaIaGssHio-bVneOs.iLnTHgAoGwaEepvpGerEor,NpcErioRamAteTbOiniRnaStimoinsossntoothct earsethsna.snitIittvheoissteocsopsnemsciadifleilerdeddcifofeiumrledpnobcreetasonftienqtoulaelsvtetaelsnchdnaoirfcdaipzl evrafoltihdremitya.cnhcoei.ceThoef combinations ooff LOLOADAIDNIGNGFAFCATCOTROSRsSo stpheact icfioemd pfaorrisothnecatensbtse maraedethbeertewfoereen tliemsittsedperinfornmuemdbienr dbifufet recnhtopsleancefsroomn NdeixOfpfeTerEreien3nt coeTcchaesisoabnfese.itnyHgophwaieplovpseroor,pphcrioyamtoebnininwahtiimocnhossttohtihsceasrstetahsna.dnaItrhdoisissecbsoapnseseciddifeieirsdeddceosiumcldrpiboberetdaonfint eqtthouealsitnaetnrcohddnauircdcatiziloevnalttihodeittyh.cehogiecneeroafl combinations of LOADING FACTORS so that comparison can be made between tests performed in different places on standard and in IEC TR 60513 NdiOffeTrEen3t oTcchaessioanfes.tyHpohwielovseor,phcyomobninwahtiiocnhs tohtihsesr ttahnadnatrhdoisse bsapseecdifieisd dceosucldribbeedoifneqthuealintetrcohdnuiccatilovnaltiodityh.e general standard and in IEC TR 60513 NOTE The safety philosophy on which this standard is based is described in the introduction to the general —sta—n—da—rd—a—nd—i—n I—EC TR 60513 —1) —I—EC—6—0—60—1-—1:—2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential 1) performance IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential ——p—er—fo—rm—a—nc—e.— 1) IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance BS EN 60601-2-44:2009+A11:2011 BS EN 60601-2-44:2009+A1:2012 – – EN 60601-2-44:2009+A11:2011 (E) EN 60601-2-44:2009+A1:2012 (E) – – BS EN 60601-2-44:2009+A11:2011 NOTE Concerning RADIOLOGICAL PROTECTION, it is assumed EtNhat60M6A0N1U-F2A-C4TU4R:2ER0S09a+nAd 11RE:2SP0O1N1SIB(EILE) ORGANIZATIONS accept the general principles of justif–ica8ti–on, optimisation, and application of dose limits of the International Commission on Radiological Protection as stated in ICRP 103, 2007, paragraph 203, [12] 2) namely: NOTE Concerning RADIOLOGICAL PROTECTION, it is assumed BtShatENMA6N0U6FA0C1T-U2R-E4R4S:2a0n0d9+RAES1P1O:N2S0IB1IL1E (OaR)G“ATNhIeZApTrIOinNcSiplaeccoef pjut stthifeicagteionne:raAl npyridneccipisleiosnotfhajut satilftiecrastiothne, RoApDtimIATisIEOatNNioen6x, p0ao6nsd0ur1ae-p2spi-lti4uca4t:io2n00soh9fo+duoAlds1ed1oli:m2mi0ots1re1ogf (otEohde) Itnhtaenrnhaatriomn.a” l Commission on Radiological Protection – – in ICRP 103, 2007, paragraph 203, [12] 2) namely: as stated (NabO) T““TEThh4ee ppCrrioninncccipieplrelenionofgfjuosRptAitfiDmcIaOistLiaoOtnGio:ICnAAnoLyf dPpeRrocOtiTseEicoCtniToIntOh:Na,Tt haeilttelriisksetlhihaeososRudAmDoIeAfdTIiOncNthuaerrtxinpgoMsAeuNrxUepFosAsiCtuuTraUetRsio,EnRthSsehoanunulddmbdReoEr mSoPofOrNepSegIoBopIoLldeE OtehxRapGnoAshNeaIZdrAm, Ta.I”OndNSthaeccmeapgt ntihtuedegeonfetrhael irprinindciivpidleusalodf ojsuestsifischaotiuolnd, aollptbime ikseaptitona,s alonwd aspprleicaastoionnabolyf adcohsieevliambiltes, otafktinhge Iinnttoerancactioounnatl eCcoomnommisiscioanndonsoRcaiedtiaollofagcictoarlsP.”rotection as stated in ICRP 103, 2007, paragraph 203, [12] 2) namely: (b) “The principle of optimisation of protection: The likelihood of incurring exposures, the number of people (e(acx))p“o“TTshheeed,pparriinnndcciiptphllee oomffaajgupnspittliiufcidcaeatitoioonfnot:hfAedniroysineddelicivmisdiituosan:l Ttdhhoaestetaoslt–taselhr4sdoou–tshldee atRollAaDbnIeAyTkIieOnpNdtivea6ixds0pu6loaos0lwu1frrao-e2sms-ri4treue4aagstuAoiolnamnatebesdlhnyosdauo.cul1dhrci©deeovsaImEbinloCepr,e:la2tang0kno1ieno2ddg teinhxtaponoashcuacrroemu.n”stiteucaotinoonms icoathnedrsotchiaental mfaecdtoicrasl.” exposure of PATIENTS should not exceed the appropriate limits recommended by the Commission.” 2(bc0) 1““T.T1hh.ee1pprirnSincccipioplelpeoefofapopplitcimatiisoantionf doofseprloimteictsti:oTnh: eTthoetalikdeolsiheotood aonfy incduivrirdinugal efrxopmosruergeusl,atehde snouumrcbeesr inofplpaenonpelde (edx)po"Asuepdrpe,licaasntidtiuoanthtieofnmsdaogsonetihtuelidrmeitshoaf fnothremtirheeidnidPciAavTlidIEueNaxTlpoddsooussreees msohifgohuPtlAdbTeaIEllNtoTbSethkesehpPotAuTaldIsENlonT’woSt adesextrrceiemaesedonnt.athbTelhyearepcfhpoirreoevpardibaoltese,e talimkinitgs rsinehtcoooumaldcmconeuonntdtebedecboyanpothpmeliiecCdaonmtodmsimossceidoeintca.a”l lfaecxtoporss.u” res However, considerations should be given to the use of dose Acodndstrtahientsfoollrowinivnegstingeatwionselenvteelns cfeor: some common diagnostic procedures This concept, now renamed as d(dcia) g“"nTAohpseptilpcicrarinetcifoeipnrelenocfoefdaloepsvepellilscim,athitoasns fboefr edtnhoesinetPrlAoimTdIuiEtcsNe:TdTdhinoesaetolatmargligedhontsuebmetboteoar nothyf ecinoPduAinvTtiIrdEiueNasT.l’"Sfrodmetrriemgeunlat.teTdhesroeufrocrees dinospelalnimneitds TsehxhpoeuolsdsurcneooptseibtueaotfaiopntphsliiesodtIhnteotremrtnheaadnitciaolmnaedxl picSoastluarenexdsp.aorHsduorweeexvoceflru, PdcAeoTnsIEsNiRdTeASrDatsIiOhooTnusHlEdsRhAnoouPtlYd eSbxIecMeUegidLvAeTnthOetRoSatphapernoudpsreisatyeosf tledimmositses NcreoOcnoTsmEtram5inetnsIdt eiosdr rbeiyncvothegesntiiCzgeoadmtiomthniastlseimovena.lns”y foofr thseomjuedgceommemntosnnedciaegsnsoasryticto pfroollcoewduthreesI.CTRhPisgecnoenrcael pptr,inncoipwlesrehnaavmeetdo baes wdmiahgdeneroebsyttihcthereeifRmeErSeaPngOceeNSliesIBvLceElrseO, RahGtaeAsdNbIZebAeyTnIOainNtsSrooadunurdccenedotoinbthyaetlharertghMeaAnNnuUmaFAbnCeTrXUo-RfREcARoYuonfTttUrhieBesEM.".E EQUIPMENT (d) "Application of dose limits for the PATIENT dose might be to the PATIENT’S detriment Therefore dose limits 2N2sh00Oo11Tu El1d15 33noItt CibsoerClelaocapoltpglealniretizaedelrdtasotlthasmantteadmdniaacdnradylasroedfxpsthoesujuredsg.emHeonwtesvneer,cecsosnasryidetoraftoiollnosw tshheouICldRPbegegnieveranl ptorintchipeleussheavoef tdoobse mcoandsetrabiyntsheoRrESinPvOeNsStiIgBaLEtioOnRGleAvNeIZlsATfIOorNSsoamnde nocot mbymtohne MdAiaNgUnFoAsCtiTcURpErRocoefdtuhreesM.E TEhQiUsIPcMoEnNcTe.pt, now renamed as dAiadgdniotisotinc:reference levels, has been introduced in a large number of countries." R20e1p.l1a.c3e theCeoxlislatitnegratlexsttaonf dthairsdssubclause with the following: NOTE It is recognized that many of the judgements necessary to follow the ICRP general principles have to be  AmAThddadiddseiittbiipooyanntrh::teicRuElSaPrONsStIaBnLEdOaRrdGANrIeZfAeTrIOsNStoandthnoost eby athpepMliAcNaUbFlAeCTcUoREllRatoef rtahel MsEtaEnQdUIaPrMdEsNT.that are listed in Clause of the general standard and Clause 201.2 of this particular standard 201.1.3 Collateral standards TThhiiss ppaarrttiiccuullaarr ssttaannddaarrdd rreeffeerrss ttoo tthhoossee aapppplliiccaabbllee ccoollllaatteerraall ssttaannddaarrddss tthhaatt aarree lliisstteedd iinn CCAIEdllaaCduui6tssi0eoe6n220: 1oo-ff1tt-hh3ee ggaeepnnpeelirreaasll ssattaasnnddmaarrodddaiafinneddd CCillnaauussCeela22u00s11e 22 2oo0ff 3tthh iissIEppCaarrt6tiicc0uu6ll0aa1rr-ss1tt-aa8nn,ddaaIErrddC 60601-1-9 and IEC 60601-1-103) not apply All other published collateral standards in the IEC 60601-1 series apply as published ITIEEhCCis66p00a66r00t11ic u11l a23r asantpdapnIlEdieaCsrd6a0rs6e0fe1mr-so1d-3tiofiaepdthpoliysneasCamlpapouldsiceifaieb2dle0i3nc.oClIlEatuCesr6ea0sl 62s00t1a2-n1ad-an8rd,d2sIE0t3Ch.a6ItE0C6a0re610-16li-s09t1e-d1a-n8ind, ICIEElCaCu66s00e6620011o f11t h91e,0g3IE)eCndeo6ra0nl6os0tt1aa-np1dp-1aly0rd.13)Aa, nllIdEoCCthl6ae0ur 6sp0eu12b-10lis-11h.21e24do)fcatohnlidlsatIpeEarCratli6cs0ut6laa0nr1ds-at1ar-dn1sd2a35inr)dd.thoenIoEt Cap6p0l6y0 1A-1ll o2set0hr1eie.r1s.p4aupbplilsyhPaeasdrtpcicuoublllaliasterhresadtla.sntdanadrdasrds in the IEC 60601-1 series apply as published RIEeCpl6a0c6e0m1e-n1t-:3 applies as modified in Clause 203 IEC 60601-1-8, IEC 60601-1-9 and F2IE0oC1r 16c.0o46lla0t1e-r1aP-la1r0st3tiac) nuddloaarrndsosttapnaupdbpallriysd.hseAdll oatfhteerr tphuisblipsahretidcucloalrlastetaranldasrtadn, dMaArdNsUFiAnCtThUeREIERSC 6n0e6e0d1-t1o  dserteiersmainpepltyheasappulbicliasbhielidty in accordance with the RISK MANAGEMENT PROCESS  RInepthlaeceIEmCen6t0: 601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular 2M200E11E 1Q2.U4IPNMoENrPmTaratutiicnvudeelarrrescfetoarnnesdnidacererdasstion, and may add other BASIC SAFETY and ESSENTIAL IPnERtFhOeRIMEACNC6E06re0q1usireermieesn, tsp.articular standards may modify, replace or delete requirements cRoenptlaaicneemd eint:the general standard and collateral standards as appropriate for the particular AMdEdE,QuUnIdPMerEN"RTepulnadcemr ecnot"n,stihde rfaotliloonw,inganndewmraefyereandcde: other BASIC SAFETY and ESSENTIAL PAErReFqOuRirMeAmNeCnEt roefqauipreamrtiecnutlsa.r standard takes priority over the general standard In the IEC 60601 series, particular standards may modify, replace or delete requirements IcEoCnta6i0n6e0d1-in1-2th:2e0g0e7n, eMraeldisctalnedlaercdtraicnadl ecqoulliaptmereanl t s–taPnadratrd1s-2:asGeanpepraolpreiaqtueirfeomr ethnets pfaortibcauslaicr sFMAaoErfreEqtbQyurUeirIavPeniMmtdyEe,NneITtEsosCufen6nad0tipe6aar0l r1tpic-ce1ournlfiaossridmrseetarafaennrtcdiroeeandr,d–ttoaCnkiondelslathmtpeirsarioayprl iatyasrttdoiacdvnuedlaraorrthdse:tragEnelBdenAaceSrtrdrIaColmassSataAgtnFhndEeeTatYirgcde.nacenordmapl EasSttiaSbnEildNitayTIrAd–L RCPEeoRqllFauOtireRerMmaAleNsnCtatEsnrdaeanqrdudtsireesamtrseenretsfe rred to by their document numbers For brevity, IEC 60601-1 is referred to in this particular standard as the general standard ATChdoredlel,aqntueunirmdaeeblmrseetr"aniAnntdgdodafoitrafidocspnla"aa,rurttesihceerueslfaoearlrnlsrodetwadsninutdogbacbrndlyeawutahskreeeeisrfsedorpoefrcnitouhcrmieist:yepnoatvrnetiurcmuthlbaeer grsset.naenrdaalrsdtacnodrraersdp onds to that of the general standard with the prefix “201” (e.g 201.1 in this standard addresses the content of Clause of the general standard) or applicable collateral standard with the prefix “20x” ITwFEohhCreerbn6eru0exm3v3ibit6sye,rtMihInEeegCdfoiic6nf a0acl6ll a0edu1liesg-c1ei tts(rsiisc)a nroeedfqf eust hriuprebemcdcel aontuloltas tei–nesrXatohl-fRisstathapyinsadTrptauiacrbduretliacdrauoslcsasutreammsnetdbananltireddnsauradfmsobrcteohmrreree(gdese.ipcgnoa.enl r2dad0sli2ast.go4tnatonihnsdaiatsthr odi–sf Ctphahoeraltlaigrcateuecnlrtaearrlaisslttaiascnntsaddnoaadfrrdadfosrdcaaadwrldeisrterhpesoftstehseresrepdtrhetefoixcbo“yn2tt0he1en”itr(oedf.ogcC.ul2ma0ue1sn.e1t 4ninuomtfhbtiehsres.t6a0n6d0a1rd-1a-2ddcroelslasteesratlhestacnodnaterndt, o2f03C.4lauinseth1is opfartthiceulgaernsetraanldsatradnaddadrdre) sosresapthpeliccaobnletenctoollaf tCelraaul sseta4ndofarthdew6i0th60th1e-1-p3recfoixlla“t2e0rxa”l Twsthhaeenrdneaurxmd,biserttcihn.e)g foTinfhaecllacduhisgaeints(gse)asnodtfosthtuhebeccltaoeulxlast teeosrfaotlhf estthaginsednpaearrdratilcdsuotlacaunr mdsaetarndntdanaruerdmsbcpeoerrcrie(feise.pgdo.nb2dy0s2tht.o4e tuihnsaetthoisf 2tpha0er1tfig.co3eullnolaewTrriaenslrgtmaswntasdonaraddrnadsrd:daddwdeirtfehinstsihteeisopntrhseefixco“n2t0e1n”t (oef.gC l2a0u1s.e1 4inotfhtihsest6a0n6d0a1rd-1a-2ddcroelslasteesratlhestacnodnaterndt, o2f03C.4lauinseth1is opfartthiceulgaernsetraanldsatradnaddadrdre) sosresapthpeliccaobnletenctoollaf tCelraaul sseta4ndofarthdew6it0h60th1e-1-p3recfoixlla“t2e0rxa”l 2ws0tha1en.r3dea.2rx0d2,isettch.e) fTinhael cdhigaint(gse) sotfoththeectoelxlat teorfatlhestagnednaerrdal dsotcaunmdaerndt anruemsbpeerci(feie.gd b2y02th.4e iunsethoisf CpthaTertCficoOulNlolaDwrITinsIOgtaNwnSdoOarFdrdsO:PaEdRdAreTIsOsNes the content of Clause of the 60601-1-2 collateral standard, A—20d—3d—.4a—in—no—tthe—is3—p—toartthicisuldaer fsintaitniodna:rd addresses the content of Clause of the 60601-1-3 collateral 2s)tandard, etc.) The changes to the text of the general standard are specified by the use of Figures in square brackets refer to the Bibliography 3Nt3h))O eTIEEfoC3ll6o0wC6Ti0n1Cg-O1N-w1D0oIT,rIdOMsNe:SdiOcFalOePlEeRcAtrTicIOalN einqculiupdmeenptar–amPaertet r1s-1th0a: tGaerenedrearl ivreqdubiryemtheentssysfotermbafrsoicm stahfeetuysaenr-dseelesscetanbtilael p—a—raIp—EmeCr—efto6e—r0rms—6a.0—n1c-—e1-—–10C,oMllaetdeircaal lSetalencdtarircda:lReeqquuipirmemenetnt–s Part 1- 10: General requirements f or basic saf ety and es s ent i al for the development of physiologic closed-loop controllers 2) Fpeigruforrems ainncsequ–aCreolblaratecrkael tSs traenfedrartdo:tRheeqBuibirleiomgeranptshyfo r the development of physiologic closed-loop controllers 4) IEC 60601-1-11, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential 3) performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems IEC 60601-1-10, Medical electrical equipment – Part 1-10: General requirements for basic safety and essential used in the home healthcare environment ——p—er—fo—rm—a—nc—e —– Collateral Standard: Requirements for the development of physiologic closed-loop controllers _25)_) _I_E_C 6_0_6_01_-1-12, Medical electrical equipment – Part 1-12: General requirements for basic safety and essential Fpeigruforremsainncsequ–aCreolblartaecrkael tSstarenfdearrtdo: tRheeqBuiibrelimogernatsphfyo.r medical electrical equipment and medical electrical systems 1) IinEtCen6d0e6d0t1o-1b-e10u,seMdeidnicthael eelmecetrrgiceanlceyqmueipdmiceanl tse–rvPiacerts1e-n1v0i:roGnemneenrta l requirements for basic safety and essential 3) pIEeCrfo6r0m6a0n1c-e1-–10C,oMllaetdeircaall Setlaencdtraicradl: eRqeuqiupimreemnten–tsPaforrt t1h-e10d:eGveelnoeprmalernetqoufirpehmyseinotlsogfoicr cblaossiecds-laofoeptycaonndtroelslesresntial performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers 2) IEC 60601-1-11, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential