Iec 60601 2 45 2015

I E C 60 60 -2 -45 ® Edition 3.1 201 5-06 C ON S OLI D ATE D VE RS I ON colour i n sid e M ed i cal el ectri cal e q u i pm e n t – P art -45: P arti cu l ar re q u i re m e n ts for th e bas i c s afe ty an d e s sen ti al perform an ce IEC 60601 -2-45:201 -02+AMD1 :201 5-06 CSV(en) of m am m og raph i c X-ra y e q u i pm en t an d m am m og raph i c s te re otacti c d evi ce s Copyright International Electrotechnical Commission T H I S P U B L I C AT I O N I S C O P YRI G H T P RO T E C T E D C o p yri g h t © I E C , G e n e v a , S wi tz e rl a n d All rights reserved Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or IEC's member National Committee in the country of the requester If you have any questions about I EC copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or your local I EC member National Committee for further information IEC Central Office 3, rue de Varembé CH-1 21 Geneva 20 Switzerland Tel.: +41 22 91 02 1 Fax: +41 22 91 03 00 info@iec.ch www.iec.ch Ab ou t th e I E C The I nternational Electrotechnical Commission (I EC) is the leading global organization that prepares and publishes I nternational Standards for all electrical, electronic and related technologies Ab o u t I E C p u b l i ca ti o n s The technical content of IEC publications is kept under constant review by the IEC Please make sure that you have the latest edition, a corrigenda or an amendment might have been published I E C Catal og u e - webstore i ec ch /catal og u e The stand-alone application for consulting the entire bibliographical information on IEC International Standards, Technical Specifications, Technical Reports and other documents Available for PC, Mac OS, Android Tablets and iPad I E C pu bl i cati on s s earch - www i ec ch /search pu b The advanced search enables to find IEC publications by a variety of criteria (reference number, text, technical committee,…) It also gives information on projects, replaced and withdrawn publications E l ectroped i a - www el ectroped i a org The world's leading online dictionary of electronic and electrical terms containing more than 30 000 terms and definitions in English and French, with equivalent terms in additional languages Also known as the International Electrotechnical Vocabulary (IEV) online I E C G l os sary - s td i ec ch /g l oss ary More than 60 000 electrotechnical terminology entries in English and French extracted from the Terms and Definitions clause of IEC publications issued since 2002 Some entries have been collected from earlier publications of IEC TC 37, 77, 86 and CISPR I E C J u st Pu bl i s h ed - webstore i ec ch /j u stpu bl i sh ed Stay up to date on all new IEC publications Just Published details all new publications released Available online and also once a month by email Copyright International Electrotechnical Commission I E C C u stom er S ervi ce C en tre - webstore i ec ch /csc If you wish to give us your feedback on this publication or need further assistance, please contact the Customer Service Centre: csc@iec.ch I E C 60 60 -2 -45 ® Edition 3.1 201 5-06 C ON S OLI D ATE D VE RS I ON colour i n sid e M ed i cal el ectri cal eq u i pm en t – P art -45: P arti cu l ar req u i rem en ts for th e bas i c s afety an d e s sen ti al pe rform an ce of m am m og raph i c X-ra y eq u i pm en t an d m am m og raph i c s te re otacti c d evi ce s INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 1 040.50 ISBN 978-2-8322-2761 -9 Warn i n g ! M ake su re th a t you obtai n ed th i s pu bl i cati on from an au th ori zed d i s tri bu tor ® Registered trademark of the International Electrotechnical Commission Copyright International Electrotechnical Commission Copyright International Electrotechnical Commission I E C 60 60 -2 -45 ® Edition 3.1 201 5-06 RE D LI N E VE RS I ON colour i n sid e M ed i cal el ectri cal e q u i pm e n t – P art -45: P arti cu l ar re q u i re m e n ts for th e bas i c s afe ty an d e s sen ti al perform an ce IEC 60000:2000-00+AMDX:201 5-01 CSV(EN) of m am m og raph i c X-ra y e q u i pm en t an d m am m og raph i c s te re otacti c d evi ce s Copyright International Electrotechnical Commission –2– CONTENTS I EC 60601 -2-45:201 +AMD1 : 201 CSV  I EC 201 FOREWORD I NTRODUCTI ON I NTRODUCTI ON to Amendment 201 Scope, obj ect and related standards 201 Normative references 201 Term s and definitions 201 General requirem ents 1 201 General requirements for testing of ME EQUI PMENT 201 Classification of ME EQUI PMENT and ME SYSTEMS 201 M E EQUI PMENT identification, m arking and documents 201 Protection against electrical HAZARDS from ME EQU I PMENT 201 Protection against MECHANI CAL HAZARDS of ME EQUI PMENT and ME SYSTEMS 201 Protection against unwanted and excessive radiation HAZARDS 22 201 1 Protection against excessive tem peratures and other HAZARDS 22 201 Accuracy of controls and instrum ents and protection against hazardous outputs 22 201 Hazardous situations and fault conditions for ME EQUI PMEN T 23 201 P ROGRAMMABLE ELECTRI CAL MEDI CAL SYSTEMS ( PEM S ) 23 201 Construction of ME EQUI PMENT 23 201 M E SYSTEMS 23 201 Electrom agnetic compatibility of ME EQUI PMENT and ME SYSTEMS 23 202 Electromagnetic com patibility – Requirements and tests 23 203 Radiation protection in diagnostic X-ray equipm ent 24 Annex AA (inform ative) Particular guidance and rationale 47 Bibliograph y 49 I ndex of defined term s used in this particular standard 50 Table 201 01 – Distributed ESSENTI AL PERFORMAN CE requirem ents 1 Table 203 01 – Minimum values of TOTAL FI LTRATI ON and factors for determ ining the minimum AI R KERMA RATE 39 Copyright International Electrotechnical Commission I EC 60 60 -2 -45: 01 + AM D :  CSV – I EC – 201 I N T E R N AT I O N AL E L E C T R O T E C H N I C AL COM M I SSI ON MEDICAL ELECTRICAL EQUIPMENT – Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices F O RE WO RD ) Th e I n t e rn a t i o n a l all n a ti o n a l i n t e rn a t i o n a l th i s end c o - o p e t i o n and Te ch n i ca l in a d d i ti o n R e p o rt s , P u b l i c a ti o n ( s ) ” ) in th e s u bj e ct g o v e rn m e n t a l wi th 2) th e d eal t b e twe e n Th e d e ci s i o n s i n t e re s t e d IEC in P u b l i ca ti o n s is o rd e r to b e twe e n th e 5) an y IEC i ts e l f s e rv i c e s Al l 7) No to I EC IEC s t a n d a rd i z a t i o n pu bl i sh es S p e c i fi c a t i o n s p a rt i c i p a t e wi th in th e fo r to th i s and (I SO) in in fo r s t a n d a rd i z a t i o n o b j e ct of e l e c t ri c a l S t a n d a rd s , an y wo rk p a rt i c i p a t e S t a n d a rd i z a t i o n th e G u ides co m m i tte e s ; p r e p a t o r y also in Th e I n t e rn a t i o n a l ( P AS ) te ch n i ca l I EC o rg a n i z a t i o n C o m m i tte e s ) and wi th fi e l d s To S p e c i fi c a t i o n s , to C o m m i tte e IEC p ro m o t e e l e c t ro n i c g o v e rn m e n t a l p re p a t i o n a c c o rd a n c e c o m p ri s i n g to re fe r r e d N a ti o n a l I n t e rn a t i o n a l , th i s is Te ch n i ca l ( h e r e a ft e r IEC I EC as and c o l l a b o t e s co n d i ti o n s “I EC i n t e re s t e d non- cl os e l y d e t e rm i n e d by of I EC re l e v a n t on te ch n i ca l s u b j e c ts s i n ce m a t t e rs e a ch e x p re s s , te ch n i ca l as n e a rl y as co m m i tte e possi bl e, has an i n t e rn a t i o n a l re p r e s e n t a t i o n fr o m al l C o m m i tte e s th e any fo r m of Wh i l e I EC end re c o m m e n d a t i o n s all re a s o n a b l e ca n n o t be h el d fo r e ffo r t s i n t e rn a t i o n a l a re mad e re s p o n s i b l e fo r to th e u se and e n s u re wa y a re th a t in a cce p te d th e wh i ch by te ch n i ca l th e y a re I EC N a ti o n a l c o n te n t u sed or of fo r I EC any u s e r i n t e rn a t i o n a l th e w o rl d w i d e m a xi m u m P u b l i ca ti o n u n i fo r m i t y , e xte n t and th e IEC possi bl e N a ti o n a l in th e i r c o rre s p o n d i n g C o m m i tte e s n a ti o n a l n a ti o n a l or an d u n d e rt a k e re g i o n a l re g i o n a l to appl y IEC p u b l i ca ti o n s p u b l i ca ti o n sh al l be P u b l i ca ti o n s An y d i v e rg e n c e c l e a rl y i n d i ca te d in l a t t e r d oes assessmen t 6) by a o rg a n i z a t i o n s th e sen se p ro m o t e t n s p a re n t l y on is N a ti o n a l c o n c e rn i n g e n t ru s t e d l i si ng two a c c u t e , m i s i n t e rp re t a t i o n In may is o r a g re e m e n t s h a ve th a t Ava i l a b l e (I EC) (I EC a c ti vi ti e s , O rg a n i z a t i o n th e N a ti o n a l P u b l i c a ti o n s C o m m i tte e s 4) wi th opi ni on IEC q u e s ti o n s o th e r o rg a n i z a t i o n s of al l p r e p a t i o n I n t e rn a t i o n a l fo r m a l on to Com m i ssi on co m m i tte e s P u bl i cl y Th ei r a g re e m e n t co n s e n s u s 3) E l e c t ro t e c h n i c a l e l e c t ro t e c h n i c a l c a rri e d u s e rs m e m b e rs shall of i ts d am ag e e xp e n s e s p ro v i d e ou t sh ou l d l i a b i l i ty o th e r n ot s e rv i c e s and, by th a t to te ch n i ca l of any a ri s i n g ou t a tte s ta ti o n som e a re a s , i n d epen d en t e n s u re a tta ch an y in th e y I EC or c o n fo rm i t y c e r t i fi c a t i o n h a ve i ts c o m m i tte e s th e l a te s t d i re c t o r s , and I EC n a t u re wh a t s o e v e r, of p u b l i ca ti o n , th e of a cce s s to IEC of c e r t i fi c a t i o n c o n fo r m i t y IEC bod i es is p ro v i d e n ot c o n fo r m i t y re s p o n s i b l e fo r any e x p e rt s an d bod i es e d i ti o n o f th i s e m p l o ye e s , N a ti o n a l wh e th e r use I n d epen d en t m a rk s o f, C o m m i tte e s d i re c t or p u b l i ca ti o n s e rv a n t s or or fo r a g e n ts an y i n d i re c t , re l i a n c e u pon , or i n cl u d i n g p e rs o n a l fo r th i s co s ts I EC i n d i vi d u al i n j u ry , p ro p e rt y (i n cl u d i n g P u b l i ca ti o n l eg al or any d amage or fe e s ) and o th e r IEC P u b l i ca ti o n s 8) At te n t i o n is d w n i n d i spen sabl e 9) At te n t i o n p a te n t is to fo r t h e d w n ri g h t s IEC to th e N o rm a t i v e c o rre c t th e sh al l p o s s i b i l i ty n ot r e fe r e n c e s a p p l i c a ti o n be hel d o f th i s th a t som e re s p o n s i b l e ci te d in th i s p u b l i ca ti o n U se of th e r e fe r e n c e d p u b l i ca ti o n s is p u b l i c a ti o n of th e e l e m e n ts fo r i d e n t i fy i n g of any th i s or al l IEC s u ch P u b l i ca ti o n p a te n t may be th e s u b j e ct of ri g h t s DISCLAIMER This Consolidated version is not an official IEC Standard and has been prepared for user convenience Only the current versions of the standard and its amendment(s) are to be considered the official documents This Consolidated version of IEC 60601 -2-45 bears the edition number 3.1 It consists of the third edition (201 -02) [documents 62B/81 7/FDIS and 62B/821 /RVD] and its amendment (201 5-06) [documents 62B/91 7/CDV and 62B/954/RVC] The technical content is identical to the base edition and its amendment In this Redline version, a vertical line in the margin shows where the technical content is modified by amendment Additions and deletions are displayed in red, with deletions being struck through A separate Final version with all changes accepted is available in this publication Copyright International Electrotechnical Commission C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an –4– I EC 60601 -2-45:201 +AMD1 : 201 CSV  I EC 201 International standard I EC 60601 -2-45 has been prepared by subcommittee 62B: Diagnostic imaging equipment, of I EC technical com mittee 62: Electrical equipm ent in m edical practice This third edition cancels and replaces the second edition published in 2001 This edition constitutes a technical revision The docum ent has been aligned to the rd edition of I EC 60601 -1 (2005) and to I EC 60601 -1 -3 (201 2008) Further m odifications have been m ade with respect to the current technolog y of MAM MOGRAPHI C X- RAY EQUI PMENT This publication has been drafted in accordance with the I SO/I EC Directives, Part In – – – this standard, the following print types are used: Requirements and definitions: roman type Test specifications: italic type I nform ative m ateri al appeari ng outside of tables, such as notes, exam ples an d references: in sm all er type Norm ative text of tabl es is also in a sm all er type – T ERMS DEFI NED I N C LAUSE OF THE GENERAL STANDARD , I N THI S PARTI CULAR S TANDARD OR AS NOTED : SMALL CAPI TALS I n referring to the structure of this standard, the term – “clause” m eans one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e g., Clause includes subclauses , 2, etc.); – “subclause” means a numbered subdivision of a clause (e g , 7.1 , and are all subclauses of Clause 7) References to clauses within this standard are preceded by the term “clause” followed by the clause num ber References to subclauses within this particular standard are by num ber onl y I n this standard, the conj unctive “or” is used as an “inclusive or” , so a statement is true if an y combination of the conditions is true The verbal forms used in this standard conform to usage described in Annex H of the I SO/I EC Directives, Part For the purposes of this standard, the auxiliary verb: – “shall” means that compliance with a requirement or a test is m andatory for compliance with this standard; – “should” m eans that com pliance with a requirem ent or a test is recom mended but is not m andatory for com pliance with this standard; – “m ay” is used to describe a permissible way to achieve com pliance 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 A list of all parts of the I EC 60601 series, published under the general title: Medical electrical equipment, can be found on the I EC website Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn Copyright International Electrotechnical Commission C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an I EC 60601 -2-45:201 +AMD1 : 201 CSV  I EC 201 –5– The com mittee has decided that the contents of the base publication and its am endm ent will rem ain unchanged until the stability date indicated on the I EC web site under "http: //webstore iec.ch" in the data related to the specific publication At this date, the publication will be • reconfirmed, • withdrawn, • replaced by a revised edition, or • am ended NOTE The attention of Nati onal Comm ittees is drawn to the fact that eq uipm ent M AN U FACTU RERS an d testing org ani zati ons m ay n eed a transitional peri od followin g pu blication of a new, am end ed or revised I EC pu blication i n which to m ake prod ucts in accordance with the new requi rem ents and to eq uip them selves for ductin g n ew or revised tests I t is the recom m endation of the com m ittee that the content of this publ i cation be ad opted for im plem entation nati on all y not earli er th an years from the date of publication I M P O RT AN T th at it – Th e co n ta i n s u n d e rs t a n d i n g of ' co l ou r c o l o u rs i ts i n si d e' wh i ch c o n te n ts l og o a re U s e rs on th e sh ou l d c o l o u r p ri n t e r Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn Copyright International Electrotechnical Commission cover c o n s i d e re d p ag e to t h e re fo re of th i s be p ri n t p u b l i cati on u s e fu l th i s fo r i n d i c ate s th e d ocu m e n t c o rre c t u si n g a C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an –6– I NTRODUCTI ON I EC 60601 -2-45:201 +AMD1 : 201 CSV  I EC 201 The third edition of this particular standard has been prepared to provide a complete set of safety requirem ents for MAMM OGRAPHI C X- RAY EQUI PMEN T , based on I EC 60601 -1 :2005 (3 rd edition) and its collaterals This particular standard addresses the system level of MAMM OGRAPHI C X- RAY EQUI PMENT , which consists of a com bination of an X- RAY GENERATOR , associated equipment and ACCESSORI ES Com ponents functions are addressed as far as necessary The minimum safety requirem ents specified in this particular standard are consi dered to provide for a practical degree of safety in the operation of MAM MOGRAPHI C X- RAY EQUI PMENT Like the previous edition of this Part 2-45, the present third edition includes requirem ents on for mammograph y HI GH - VOLTAGE GENERATORS INTRODUCTION to Amendment This first amendm ent to the third edition of this particular standard has been prepared to provide a complete set of safety requirements for MAM MOGRAPHI C X- RAY EQUI PMEN T , based on I EC 60601 -1 : 2005 and I EC 60601 -1 : 2005/AMD1 : 201 2, I EC 60601 -1 -2: 201 4, and I EC60601 -1 -3: 2008 and I EC60601 -1 -3: 2008/AM D1 : 201 This particular standard addresses the system level of MAMM OGRAPHI C X- RAY EQUI PMENT and introduces equipment for MAMM OGRAPHI C TOMOSYN THESI S Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn Copyright International Electrotechnical Commission C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an – 40 – I EC 60601 -2-45:201 +AMD1 : 201 CSV  I EC 201 – Perform an exposure using the same procedure as prescribed for an average 45 mm compressed breast – Measure the LOADING TIME 203.7 R AD I AT I O N Q U AL I T Y 203.7.1 H AL F - V AL U E L AYE R S a n d T O T AL F I L T R AT I O N in X- R AY E Q U I P M E N T Replacement: The RADI ATI ON QUALI TY of the X- RAY BEAM provided by the X- RAY EQUI PMEN T shall be appropriate for producing the intended im ages without adm inistering unnecessaril y high doses to the PATI ENT The TOTAL FI LTRATI ON in the beam needs to be sufficient in order to achieve the preceding goal Requirements for m inim um FI LTRATI ON are given here in term s of total QUALI TY EQUI VALENT FI LTRATI ON or of the first HALF - VALUE LAYER for specified X- RAY TUBE VOLTAGE I n MAM MOGRAPHI C X- RAY EQUI PMENT , for all configurations available in N ORMAL USE and for all com binations of TARGET and FI LTER m aterials given in Table 203 01 , the TOTAL FI LTRATI ON shall not be less than the value given in Table 203.1 01 for the respective EDGE FI LTER For combinations of TARGET and FI LTER materials not given in Table 203.1 01 , the TOTAL shall be high enough so that the first HALF - VALUE LAYER (expressed in m m of alum inum) attained in the X- RAY BEAM incident on the PATI ENT , excluding the m aterial of an y com pression plate, is not less than the value of the high voltage (expressed in kV) divided by 00, for all configurations available in N ORMAL USE FI LTRATI ON The material of an y com pression plate is not included in the TOTAL FI LTRATI ON Addition: 203.7.1 01 U n fi l t e re d I R R AD I AT I O N p re v e n t i o n I f an X- RAY SOURCE ASSEMBLY includes selectable ADDED FI LTERS , m eans shall be provided to prevent I RRADI ATI ON in absence of the appropriate ADDED FI LTER 203.7.3 I n d i c a t i o n o f F I L T E R p ro p e rt i e s Addition: Alternative to the m arking of X- RAY TUBE ASSEMBLI ES required in subclause 7.3 of I EC 60601 -3: 2008 and I EC 60601 -1 -3: 2008/AMD1 : 201 3, the FI LTER properties of X- RAY TUBE ASSEMBLI ES may be provided in the ACCOMPANYI N G DOCUMENTS when a single type of X- RAY TUBE ASSEMBLY can be fitted on the equipm ent or when the X- RAY TU BE ASSEMBLY is not accessible in N ORMAL USE 203.7.6 T e s t fo r H AL F - V AL U E L AY E R Replacement: For X-RAY EQUIPMENT specified exclusively for mammography, ensure that the compression plate is not in the X-RAY BEAM during the determination of the HALF-VALUE LAYER NOTE The exclusion of the com pression pl ate from the m easurem ent is not in contradiction with of I EC 60601 -1 -3 because M AM M OGRAPH I C X- RAY EQU I PM EN T usuall y incl udes perforated com pression plates for breast biopsy Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn Copyright International Electrotechnical Commission C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an I EC 60601 -2-45:201 +AMD1 : 201 CSV  I EC 201 – 41 – For each ADDED FILTER specified as necessary to attain the requirements for TOTAL FILTRATION in the MAMMOGRAPHIC X- RAY EQUIPMENT, given in 203.7.1, measure the first HALF-VALUE LAYER under NARROW BEAM CONDITIONS with the MAMMOGRAPHIC X-RAY EQUIPMENT operating at – – minimum selectable value of X-RAY TUBE VOLTAGE; one typical intermediate value of X-RAY TUBE VOLTAGE specified as representative of the INTENDED USE, using LOADING FACTORS corresponding to the range of NORMAL USE 203.8 L i m i ta ti o n b e twe e n 203.8.5 203 an d i n d i ca ti o n o f t h e e xt e n t o f t h e X- R AY B E AM an d re l a t i o n s h i p X- R AY F I E L D a n d I M AG E R E C E P T I O N AR E A Re l a t i o n s h i p b e t w e e n X- R AY F I E L D a n d * C o rre s p o n d e n c e b e t w e e n I M AG E X- R AY F I E L D a n d RE C E P T I O N E F F E C TI VE AR E A I M AG E RE C E P TI O N AR E A Addition: I n non-magnification mode the X- RAY FI ELD a) shall not extend m ore than mm beyond the edge of the PATI ENT SUPPORT that is designed to be adjacent to the chest wall of the PATI ENT , b) for non-scanning MAM MOGRAPHI C X- RAY EQUI PMEN T , shall extend beyond the edge of the EFFECTI VE I MAGE RECEPTI ON AREA that is designed to be adj acent to the chest wall of the PATI ENT , c) for non-scanning MAM M OGRAPHI C X- RAY EQUI PMEN T , shall not extend by more than % of the DI RECT FOCAL DI STAN CE beyond all other edges of the EFFECTI VE I MAGE RECEPTI ON AREA For MAM MOGRAPHI C TOMOSYNTHESI S this requirem ent is excluded I n this particular standard, the boundary of an X- RAY FI ELD is described by the locus of points at which the AI R KERMA RATE is 25 % of the mean of the AI R KERMA RATES at the approxim ate centres of the quarters of the area enclosed For MAMM OGRAPHI C X- RAY EQUI PMENT based on scanning that varies the position for receiving an X- RAY PATTERN during the exposure, the total area, that is being im aged, is to be used instead of the EFFECTI VE I MAGE RECEPTI ON AREA 20 Posi ti on i n g o f t h e P AT I E N T a n d re s t ri c t i o n o f t h e i rra d i a t e d a re a Addition: M E EQUI PMENT shall be equipped with a LI GHT FI ELD I NDI CATOR For non-scanning MAM MOGRAPHI C X- RAY EQUI PMEN T , the LI GHT FI ELD shall be aligned with the X- RAY FI ELD so that the m isalignment of the edges of the LI GHT FI ELD and the X- RAY FI ELD along either the length or the width of the visuall y defined field at the plane of the breast support surface does not exceed % of the DI RECT FOCAL DI STAN CE 1 1 *M i s s e d ti s s u e a t c h e s t wa l l side R e q u i re m e n t I n non-m agnification mode the m axim um distance between the edge of the I MAGE RECEPTI ON AREA that is designed to be adj acent to the chest wall of the PATI ENT and the adj acent edge of the PATI ENT SUPPORT , when proj ected on the PATI ENT SUPPORT , shall be smaller than mm Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn Copyright International Electrotechnical Commission C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an – 42 – 1 I EC 60601 -2-45:201 +AMD1 : 201 CSV  I EC 201 T e s t m e th o d Position a TEST DEVICE on the PATIENT SUPPORT; this TEST DEVICE shall include test objects in contact with the PATIENT SUPPORT and allow measurement of distances from the chest wall edge of the PATIENT SUPPORT in the resulting radiograms with a precision of 0, mm over a length of mm or more This TEST DEVICE shall include means to position it repeatedly relative to the edge of the PATIENT SUPPORT Make a radiogram of the TEST DEVICE On the radiogram, measure the distance from the edge of the PATIENT SUPPORT to the edge of the IMAGE RECEPTION AREA For MAMMOGRAPHIC X-RAY EQUIPMENT with non-integrated X-RAY IMAGE RECEPTORS , the test shall be repeated times, including repositioning the TEST DEVICE, to identify the largest value The largest value shall be kept as the final one Compliance is checked by the appropriate test 2 B R E AS T C O M P R E S S I O N D E V I C E G e n e l All MAM MOGRAPHI C X- RAY EQUI PMENT shall be fitted with a power-driven BREAST COMPRESSI ON DEVI CE C o n t ro l o f c o m p re s s i o n m ovem en ts All switches controlling movem ent for the application of com pression shall be of the type requiring continuous actuation while m ovement takes place The X- RAY EQUI PMENT shall – provide means for hands-free, (e g foot), control of the power-driven compression accessible from both sides of the position of the PATI ENT ; – include m eans for fine adjustm ent of the compression force accessible from both sides of the position of the PATI EN T and; – provide means for the OPERATOR to prevent autom atic decompression I n the event of interruption of SUPPLY MAI NS during biopsy or marking operations, the com pression shall be maintained H owever, means shall be provided for manuall y achieving com plete decom pression Ra n g e o f m o v e m e n t I n all conditions of NORM AL USE , the available range of movem ent of the BREAST COMPRESSI ON DEVI CE shall allow all those parts of the compression plate that are designed to be in contact with the breast to be brought within mm of the surface of the PATI ENT SU PPORT NOTE This requi rem ent is intend ed to ensu re th at adeq uate com pression of sm all or thi n breasts is not prevented by l im itation of th e available m ovem ent of the com pression pl ate The extent of com pression appli ed to an y particu lar PATI EN T is control led by the OPERATOR and m ay be lim ited by restriction of the available operati ng force; see 203 02 Desi g n o f c o m p re s s i o n p l a te s Compression plates intended for special purposes are not subject to the requirements of this subclause Compression plates matching the sizes of all breast supports shall be provided Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn Copyright International Electrotechnical Commission C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an I EC 60601 -2-45:201 – 43 – +AMD1 : 201 CSV  I EC 201 Com pression plates shall be transparent so that the skin of the PATI ENT remains visible when in contact with them When predefined AEC sensor positions are provided and when other means for indication are not provided, the MAM M OGRAPHI C X- RAY EQUI PM ENT shall include at least one compression plate for each X- RAY I MAGE RECEPTOR format used in an AUTOMATI C EXPOSURE CONTROL mode m arked to indicate the range of sensor positions available in NORMAL USE The edge of the compression plate intended to be in contact with the chest wall of the PATI ENT shall not extend beyond the chest wall edge of the EFFECTI VE I MAGE RECEPTI ON AREA by m ore than one percent of the DI RECT FOCAL DI STAN CE when the compression plate is placed 45 mm above the surface of the breast support No im age of this edge of the compression plate shall be visible 203.8.5.4.1 02.5 Strength of compression plates Com pression plates and their m ountings, unless m arked to indicate the maxim um com pression force permitted to be applied, shall withstand the maxim um com pression force attainable when they are fitted to ME EQUI PMENT The marking may take the form of coding related to an explanation in the instructions for use Compliance is determined by the following test: a) Test equipment The following test equipment is required: – appropriately sized objects, one for each X- RAY IMAGE RECEPTOR format, leading to sufficiently realistic force distributions when under compression E.g., the objects can be sand-filled bags or soft rubber blocks Their thickness shall be in the range from 20 mm to 50 mm The objects shall be 100 mm to 120 mm long and wide for the smallest X- RAY IMAGE RECEPTOR format and 120 mm to 150 mm long and wide for larger formats b) Test procedure Position the MAMMOGRAPHIC X-RAY EQUIPMENT to acquire a cranio-caudal projection of the breast Mount a compression plate Take the test object designed for the same X- RAY IMAGE RECEPTOR format as the compression plate and place it on the PATIENT SUPPORT, centred laterally, and with one edge as close as possible to that edge of the PATIENT SUPPORT that is provided to be adjacent to the PATIENT'S chest wall If the object is a sand-filled bag, shape it by hand to maximize the surface areas that will be in contact with the PATIENT SUPPORT and the compression plate Actuate the BREAST COMPRESSION DEVICE to the maximum attainable compression force or to the maximum compression force permitted to be applied to the plate Then relax the force Repeat the test for all compression plates c) Interpretation of test results Inspect the compression plates and associated parts for any signs of damage, especially for fissures For compliance, the compression plates and associated parts are to be free from breakage, visible damage and permanent distortion 203.8.5.4.1 02.6 Compression force B REAST COMPRESSI ON DEVI CES shall satisfy the following requirem ents in respect of the application and indication of the com pression force in all orientations specified for NORMAL USE : – no BREAST COMPRESSI ON DEVI CE shall be able to apply a force exceeding 300 N ; Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn Copyright International Electrotechnical Commission C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an – 44 – – I EC 60601 -2-45:201 +AMD1 : 201 CSV  I EC 201 for power-driven compression, the BREAST COMPRESSI ON DEVI CE shall be able to appl y a force of at least 50 N, and it shall be unable to appl y a force exceeding 200 N ; NOTE Equipm ent configu rati ons that lim it the m axim um power-driven com pression force to less than 50N i n clinical use are perm issible See followin g bu llet – for power-driven com pression, the available operating force shall be adjustable down to 70 N or less; – if the value of the applied force is displayed, the indication shall be accurate to ± 20 N Compliance is checked by measurement a) Test equipment The following test equipment is required: – a force balance; – a soft rubber block, 20 mm to 50 mm thick, and 100 mm to 120 mm long and wide b) Test procedure Position the MAMMOGRAPHIC X-RAY EQUIPMENT to acquire a cranio-caudal projection of the breast Fix the force balance onto the PATIENT SUPPORT so that it will remain secure in any orientation of the MAMMOGRAPHIC X-RAY EQUIPMENT Place the soft rubber block on the sensitive area of the force balance Operate the BREAST COMPRESSION DEVICE, thus clamping the soft rubber block, and record the reading of the balance Measure the highest achievable forces for all compression modes If the force is displayed at the X-RAY EQUIPMENT then perform at least five additional measurements for lower compression forces, equally distributed over the range from zero compression to the maximum attainable compression force and record all displayed values in combination with the readings of the balance Repeat the test procedure for at least three other orientations of the MAMMOGRAPHIC X-RAY EQUIPMENT in order to cover sufficiently the whole range of angles possible with the X- RAY EQUIPMENT c) Interpretation of measured data Determine compliance by comparing MEASURED VALUES with required values and, if the compression force is displayed, with the above requirements for accuracy 203.9 F O C AL S P O T T O S KI N D I S T AN C E Replacement: The FOCAL SPOT TO SKI N DI STANCES RADI ATI ON dose to the PATI ENT as in NORMAL USE shall be sufficientl y large to keep the low as reasonabl y achievable This is obtained by compliance with the following requirements Except when a MAM MOGRAPHI C STEREOTACTI C DEVI CE is used, the DI RECT FOCAL DI STANCE shall be at least 600 m m The magnification factor in the plane of the PATI ENT SUPPORT to be used for geom etric m agnification shall not exceed Compliance is checked by measurement 203.1 A T T E N U AT I O N o f t h e X- R AY B E AM b e t w e e n t h e P AT I E N T a n d RE C E P T O R 203.1 G e n e l Addition: Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn Copyright International Electrotechnical Commission t h e X- R AY I M AG E C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an I EC 60601 -2-45:201 – 45 – +AMD1 : 201 CSV  I EC 201 The ATTENUATI ON EQUI VALENT of the total of all layers of the breast support located in the path of the X- RAY BEAM between the breast and the X- RAY I MAGE RECEPTOR shall not exceed 0, mm Al when measured perpendicular to these layers This requirem ent does not apply to protective layers of X- RAY I M AGE RECEPTORS , to radiographic cassettes, and to ANTI - SCATTER GRI DS Compliance is checked by measurement Determine the ATTENUATION EQUIVALENT as the thickness of aluminium that gives the same degree of attenuation as the breast support, from measurements of AIR KERMA under NARROW BEAM CONDITION Use an X- RAY TUBE VOLTAGE of approximately 30 kV, a ripple of not more than 10%, and a first HALF-VALUE LAYER of 0, mm +/- 0,01 mm Al 203.1 P ro t e c t i o n a g a i n s t R E S I D U AL R AD I AT I O N Additional subclause: 203 1 01 Ad d i t i o n a l re q u i re m e n t s fo r p ro t e c t i o n a g a i n s t RE S I D U AL R AD I AT I O N M AM MOGRAPHI C X- RAY EQUI PMEN T shall be provided with PRI MARY PROTECTI VE SHI ELDI NG in accordance with the requirements below These requirements shall be m et for all com binations of X- RAY FI ELDS , DI RECT FOCAL DI STANCES , LOADI N G FACTORS and FI LTRATI ON in NORMAL USE The PRI MARY PROTECTI VE SHI ELDI NG shall extend at least to the projection of the PATI ENT SUPPORT at the edge designed to be adjacent to the PATI ENT ' S chest wall and at the other edges shall extend beyond the X- RAY FI ELD by at least % of the DI RECT FOCAL DI STAN CE The RESI DUAL RADI ATI ON behind the X- RAY I MAGE RECEPTOR supporting device shall not exceed an AI R KERMA of , µ G y per I RRADI ATI ON Compliance is checked by visual inspection and by the following measurement The AIR KERMA measurement shall be averaged over a detection area that is 100 cm 2, of which no linear dimension is greater than 200 mm, centred at 50 mm from any ACCESSIBLE SURFACE beyond the X- RAY IMAGE RECEPTOR supporting device Fit shielding in the plane of the PATIENT SUPPORT as necessary to exclude from the measurement any X- RADIATION not transmitted through the PRIMARY PROTECTIVE SHIELDING For MAMMOGRAPHIC TOMOSYNTHESIS mode of operation, the test shall be performed using a tomosynthesis sweep It shall be tested for all available tomosynthesis configurations The reference X-RAY TUBE VOLTAGE for compliance shall be the NOMINAL X- RAY TUBE VOLTAGE The reference LOADING FACTORS for compliance shall be those corresponding to the maximum energy input in a single LOADING according to the RADIOGRAPHIC RATINGS If the maximum energy input in a single LOADING according to the RADIOGRAPHIC RATINGS cannot be obtained at the NOMINAL X-RAY TUBE VOLTAGE, the worst case of combinations of the LOADING FACTORS and FILTRATION shall be determined and used I f LOADI NG FACTORS can ACCOMPANYI NG DOCU MEN TS FACTORS for test be controlled only by an AUTOMATI C CON TROL SYSTEM , the shall include instructions for obtaining appropriate LOADI NG Compliance is checked by inspection of the test results and by examination of the design documentation and ACCOMPANYING DOCUMENTS Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn Copyright International Electrotechnical Commission C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an – 46 – 203 P ro t e c t i o n I EC 60601 -2-45:201 +AMD1 : 201 CSV  I EC 201 a g a i n s t S T R AY R AD I AT I O N Additional subclause: 203 01 P RO T E C T I V E B AR RI E R M AM MOGRAPHI C X- RAY EQUI PMEN T for which a SI GNI FI CANT ZONE OF OCCU PANCY is designated shall have a PROTECTI VE BARRI ER which is designed to be placed between the SI GNI FI CANT ZONE OF OCCUPAN CY and the region of the PATI ENT SUPPORT The PROTECTI VE BARRI ER shall not prevent the OPERATOR from observing the PATI ENT during the acquisition of mamm ograms I t shall extend from not m ore than 50 mm above the floor to a height of not less than 85 cm , and its width shall not be less than 60 cm NOTE The h eig ht of a SI G N I FI CAN T ZON E OF OCCU PAN CY as specified i n I EC 60601 -1 -3 d oes not necessaril y im ply that the PROTE CTI VE BARRI E R as specified in this stan dard h as the sam e height With an emitting TARGET of mol ybdenum, an X- RAY TUBE VOLTAGE of 35 kV with a percentage ripple of not more than and a TOTAL FI LTRATI ON of 0, 03 mm molybdenum , the ATTENUATI ON EQUI VALENT of this PROTECTI VE BARRI ER shall not be less than 0, 08 m m of lead The PROTECTI VE BARRI ER shall be perm anentl y m arked with its ATTEN UATI ON EQUI VALENT with reference to this standard Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn Copyright International Electrotechnical Commission C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an I EC 6060 -2 -45: 01 + AM D : CSV  – 47 I EC 201 – Annex AA ( i n fo rm a t i v e ) Particular guidance and rationale AA.1 Rationale for particular clauses and subclauses Th e fo l l o w i n g wi th cl a u s e a re and t i o n a l e s s u b cl a u s e fo r s p e c i fi c n u m b e rs cl a u s e s p a l l e l to and th o s e s u b cl a u s e s in th e in th i s b o d y o f th e p a rt i c u l a r s t a n d a rd , d o cu m e n t Subclause 201 3.206 – MAMMOGRAPHIC STEREOTACTIC DEVICE Th i s d e fi n e d eq u i pm en t t e rm th a t h as been ca n be c l a ri fi e d u sed and fo r m o d i fi e d t h re e to i n cl u d e d i m en si on al M AM M O G R AP H I C l o ca l i za ti o n T O M O S YN T H E S I S an d i n t e rv e n t i o n a l m a m m o g p h i c g u i d a n c e Subclause 201 4.3.1 01 – Additional ESSENTIAL PERFORMANCE requirements Th e th e be i d e n t i fi c a t i o n co m p e n s a te d Th i s of a s s o ci a te d RI S K E S S E N T I AL wi th b y th e p a rt i c u l a r s t a n d a rd X- RAY M AM M O G R AP H I C o f th e Th i s a rt t o p ro d u c e imag ing d e g d a t i o n ) te s ti n g ) fo r t h e C o n s e q u e n tl y ta b l e c a re EQU I PM EN T i m ag es a d e q u a te i n s ta l l e d u sed ATI O N fro m th e b y a d e q u a te co m p l i e s m ay be h as th e been g e n e t e sin gle th e fa c t i mages th a t sh ou l d an d i mag in g p e rfo rm a n c e e co n o m i ca l l y vi a b l e of s ta te C O N D I TI O N S fa u l t p ro c e d u re s by b re a s t s c re e n i n g ) th a t th e te ch n i ca l l y N O RM AL j u s t i fi e d m a m m o g p h i c (e g , re q u i re m e n t s wi th made m a i n te n a n ce to p ro c e d u re o f s u ffi c i e n t q u a l i t y i n p e rfo rm a n c e by X- RAD I b e n e fi t e x p e c t e d ta ke s re q u i re m e n t s P E RF O RM AN C E i on i zi n g s a fe ( i n cl u d i n g (e g , against a cc e p ta n c e u n d e te cte d an d co n s ta n cy e q u i p m e n t re q u i re m e n t s th a t h a ve n ot been i d e n t i fi e d as B AS I C a re S AF E T Y l i s te d in 201 01 Subclause 201 7.9.2.1 – M E EQUIPMENT emitting radiation Th i s re q u i re m e n t a d d i ti o n a l o f th e re q u i re m e n t s g e n e l in s t a n d a rd is s u ffi c i e n t l y a d d re s s e d t h ro u g h I EC 606 01 -1 -3 and 201 Subclause 201 9.2.1 01 – Three dimensional localization and interventional mammographic guidance Ac c u t e p o s i ti o n i n g a c c u c y o f t h e S ta b i l i ty of p o s i ti o n i n g Th e ME RI S K of th e th e C O M P RE S S I O N a c c u c y o f t h e a s s o ci a te d EQU I PM EN T X- R AY S O U RCE AS S E M B L Y is re q u i re d to e n s u re th e p o s i ti o n i n g bi opsy n eed l e wi th u n d er D E VI C E an d bi opsy n eed l e th i s s u b cl a u s e c o n s i d e t i o n and P AT I E N T and s t ro n g l y is S U P P O RT P AT I E N T d epen d s s u b j e ct to a re n e c e s s a ry to e n s u re th e s a fe t y th e on RI S K th e c o n s t ru c t i o n M AN AG E M E N T d e ta i l s P RO C E S S of th e of th e M AN U F AC T U RE R T o m o s yn th e s i s h as m o ve m e n t o f th e been s p e c i fi c a l l y x - y s o u rc e d u ri n g e xcl u d e d fro m a cq u i s i ti o n Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn Copyright International Electrotechnical Commission th i s s u b cl a u s e b e ca u s e of th e possi bl e C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an – 48 – I EC 60601 -2-45:201 +AMD1 : 201 CSV  I EC 201 S u b c l a u s e 1 – L O AD I N G T I M E The first paragraph gives the specified m ethod for the m easurem ent of the loading time according to I EC 60601 -1 -3 The 2nd and 3rd paragraph are the respective tests for the technical im plem entations of x-ray generator designs Technical designs not covered by the second or third paragraph are subj ect to the 4th paragraph Su b cl au s e – Rep l a c em en t of d ata o ri g i n a t i n g fro m D E F E C TI VE D E TE C TO R E L E M E N TS For MAMM OGRAPHI C X- RAY EQUI PMENT with an integrated digital detector, quality control is used to verify the system s compliance with the MAN UFACTURER ’ S specification I t is the RESPONSI BLE ORGANI SATI ON ’ S task to perform this quality control Su b cl au s es RE C E P TI O N 203 8.5 AR E A an d – C o rre s p o n d e n c e 1 – M i ss ed b e twe e n X- R AY FI ELD ti s s u e at c h e s t wal l an d E F F E C TI VE I M AG E si d e Since the first edition of I EC 60601 -1 -3, it has been required that the X- RAY FI ELD extends to the edge of the PATI ENT SUPPORT , and a m m extension beyond that edge has been allowed This subclause was justified by the fact that the capability to cover the film full y up to its very edge was then given special attention when considering lim itation of excessive I RRADI ATI ON The benefit was to ensure com plete blackening of the film near the edge adjacent to the chest wall of the PATI ENT , essential for good viewing conditions, thus increasing the im aged area towards the chest wall where som e pathologies may reside This new requirement helps to satisfy Clause 1 , protection against RESI DUAL RADI ATI ON , of I EC 60601 -1 -3: 2008 by preventing parts of the PATI ENT other than from those being currentl y imaged, to be reached by direct unattenuated X- RADI ATI ON (e.g., on both sides of the breast), and therefore gives full effectiveness to 203 1 01 of this standard Because it is technicall y difficult to achieve no X- RADI ATI ON beyond the PATI ENT SUPPORT , a mm tolerance is perm itted Because in MAMM OGRAPHI C TOMOSYNTHESI S equipment the angulation of the source m ay generate a translation of the beam , the restriction for the correspondence between X-ray field and effective im age reception area has been relaxed, with the exception of the chest wall side H owever, patient protection is ensured by 203 1 Protection against RESI DUAL RADI ATI ON where the primary protective barrier requirem ent has been m ain tained Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn Copyright International Electrotechnical Commission C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an I EC 60601 -2-45:201 +AMD1 : 201 CSV  I EC 201 – 49 – Bibliography [1 ] I EC 6041 7, Graphical symbols for use on equipment [2] I EC 60601 -2-7: 998, Medical electrical equipment – Part 2-7: Particular requirements [3] I EC 60601 -2-28:1 993, Medical electrical equipment – Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis for the safety of high voltage generators of diagnostic X-ray generators (withdrawn) [4] I EC 60601 -2-28: 201 0, Medical electrical equipment - Part 2-28: Particular requirements [5] I EC 60601 -2-32: 994, Medical electrical equipment – Part 2: Particular requirements for the safety of associated equipment of X-ray equipment [6] I EC 60664-1 : 2007, Insulation coordination for equipment within low-voltage systems – [7] I SO 4090: 2001 , Photography – Medical radiographic cassettes/screens/films and hard- [8] I SO 7000: 2004, Graphical symbols for use on equipment – Index and synopsis [9] I SO 9236-3: 999, Photography – Sensitometry of screen/film systems for medical radiography – Part 3: Determination of sensitometric curve shape, speed and average gradient for mammography for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis Part : Principles, requirements and tests copy imaging films – Dimensions and specifications [1 0] I SO 2052, Health informatics – Digital imaging and communication in medicine (DICOM) including workflow and data management [1 ] I EC 61 223-3-2: 2007, Evaluation and routine testing in medical imaging departments – Part 3-2: Acceptance tests – Imaging performance of mammographic X-ray equipment Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn Copyright International Electrotechnical Commission C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an – 50 – I EC 60601 -2-45:201 +AMD1 : 201 CSV  I EC 201 I n d e x o f d e fi n e d te rm s u s e d i n t h i s p a rt i c u l a r s ta n d a rd NOTE I n the present d ocu m ent only term s defined eith er in I EC 60601 -1 : 2005, its collateral stand ards, in I EC/TR 60788: 2004 or in Clause 201 of this particul ar stan d ard were used ACCESSI BLE PART I EC 60601 -1 : 2005, ACCESSI BLE SURFACE I EC 60601 -1 -3: 2008, ACCESSORY I EC 60601 -1 : 2005, 3 ACCOMPANYI NG DOCU MEN T I EC 60601 -1 : 2005, ADDED FI LTER I EC 60601 -1 -3: 2008, 3.2 ADDI TI ONAL FI LTRATI ON I EC 60601 -1 -3: 2008, 3.3 AI R KERMA I EC 60601 -1 -3: 2008, AI R KERMA RATE I EC 60601 -1 -3: 2008, ANTI - SCATTER GRI D I EC/TR 60788: 2004, rm -32-06 APPARENT RESI STAN CE OF SUPPLY MAI NS 201 3.201 APPLI ED PART I EC 60601 -1 : 2005, ARTEFACT I EC/TR 60788:2004, rm -32-67 ATTEN UATI ON I EC 60601 -1 -3: 2008, 3.7 ATTEN UATI ON EQUI VALEN T I EC 60601 -1 -3: 2008, 3.8 AUTOMATI C CONTROL SYSTEM I EC 60601 -1 -3: 2008, 3.9 AUTOMATI C EXPOSU RE CONTROL I EC 60601 -1 -3: 2008, 3.1 AVERAGE GLANDULAR DOS E (AGD) 201 3.202 B ASI C SAFETY I EC 60601 -1 : 2005, B EAM LI MI TI NG DEVI CE I EC 60601 -1 -3: 2008, 3.1 B REAST COMPRESSI ON DE VI CE 201 3.203 C LASS I I EC 60601 -1 : 2005, 3 C ONTRAST TO NOI SE RATI O 201 21 C ONTROL PANEL I EC 60601 -1 -3: 2008, C URRENT TI ME PRODU CT I EC 60601 -1 -3: 2008, 3.1 C YCLE TI ME I EC 6061 3: 201 0, D EFECTI VE DETECTOR ELEMENT 201 3.204 D I APHRAGM I EC 60601 -1 -3: 2008, D I RECT FOCAL DI STAN CE 201 3.205 E ARTH LEAKAGE CU RRENT I EC 60601 -1 : 2005/AMD1 :201 2, 25 E DGE FI LTER I EC 60601 -1 -3: 2008, 3.1 E FFECTI VE I MAGE RECEPTI ON AREA I EC 60601 -1 -3: 2008, 20 E N CLOSURE I EC 60601 -1 : 2005, 26 E NTRAN CE SURFACE I EC 60601 -1 -3: 2008, 3.21 E SSENTI AL PERFORMANCE I EC 60601 -1 : 2005/AMD1 :201 2, 27 F I LTER I EC 60601 -3: 2008, 23 F I LTRATI ON I EC 60601 -1 -3: 2008, 24 F OCAL SPOT I EC/TR 60788:2004, rm -20-1 3s F OCAL SPOT TO SKI N DI STANCE I EC 60601 -1 -3: 2008, 3.26 H ALF - VALUE LAYER I EC 60601 -1 -3: 2008, 3.27 Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn Copyright International Electrotechnical Commission C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an I EC 60601 -2-45:201 – 51 – +AMD1 : 201 CSV  I EC 201 H AZARD I EC 60601 -1 : 2005/AMD1 :201 2, 39 H I GH - VOLTAGE CABLE CON NECTI ON I EC/TR 60788: 2004, rm -20-1 H I GH - VOLTAGE GENERATOR I EC/TR 60788:2004, rm -21 -01 I MAGE RECEPTI ON AREA I EC 60601 -1 -3: 2008, 3.28 I NDI CATED VALUE I EC/TR 60788:2004, rm -73-1 I NTEN DED USE I EC 60601 -1 : 2005/AMD1 : 201 2, 44 I NTERNALLY POWERED I EC 60601 -1 : 2005, 46 I RRADI ATI ON I EC 60601 -1 -3: 2008, 30 I RRADI ATI ON TI ME I EC 60601 -1 -3: 2008, 32 L EAKAGE CURRENT I EC 60601 -1 : 2005, 47 L I GHT FI ELD I EC/TR 60788:2004, rm -37-09 L I GHT FI ELD I NDI CATOR I EC/TR 60788: 2004, rm -37-31 L OADI N G I EC 60601 -1 -3: 2008, 34 L OADI N G FACTOR I EC 60601 -1 -3: 2008, 35 L OADI N G STATE I EC 60601 -1 -3: 2008, 3.36 L OADI N G TI ME I EC 60601 -1 -3: 2008, 37 M AI NS VOLTAGE I EC 60601 -1 : 2005, 54 M AM MOGRAPHI C STEREOTACTI C DEVI CE 201 206 M AM MOGRAPHI C TOMOSYN THESI S 201 3.21 M AM MOGRAPHI C X- RAY EQUI PMENT 201 207 M AN UFACTU RER I EC 60601 -1 : 2005/AMD1 :201 2, 55 M EASURED VALUE I EC 60601 -1 -3: 2008, 3.38 M ECHANI CAL HAZARD I EC 60601 -1 : 2005, 61 M EDI CAL ELECTRI CAL EQUI PMENT ( ME EQUI PMENT ) I EC 60601 -1 : 2005, 63 M EDI CAL ELECTRI CAL SYSTEM ( ME SYSTEM ) I EC 60601 -1 : 2005, 64 M OBI LE I EC 60601 -1 : 2005/AMD1 :201 2, 65 M ODEL OR TYPE REFEREN CE I EC 60601 -1 : 2005, 66 M ODE OF OPERATI ON I EC 60601 -1 -3: 2008, 3.40 N ARROW BEAM CONDI TI ON I EC 60601 -1 -3: 2008, 41 N OI SE I EC 62220-1 -2: 2007, N OMI NAL ( VALUE ) I EC 60601 -1 : 2005, 69 N OMI NAL FOCAL SPOT VALUE I EC/TR 60788:2004, rm -20-1 N OMI NAL X- RAY TUBE VOLTAGE I EC 60601 -1 -3: 2008, 3.42 N ORMAL CON DI TI ON I EC 60601 -1 : 2005, 70 N ORMAL USE I EC 60601 -1 : 2005, 71 O PERATOR I EC 60601 -1 : 2005, 73 O RI GI NAL DATA ( DN) 201 208 P ATI ENT I EC 60601 -1 : 2005/AMD1 : 201 2, 76 P ATI ENT SUPPORT I EC/TR 60788:2004, RM -30-02 P ERCENTAGE RI PPLE I EC 60601 -1 -3: 2008, 44 P ERMANENT FI LTRATI ON I EC 60601 -1 -3: 2008, 3.45 P ERMANENTLY I NSTALLED I EC 60601 -1 : 2005, 84 P HANTOM I EC 60601 -1 -3: 2008, 46 Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn Copyright International Electrotechnical Commission C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an – 52 – I EC 60601 -2-45:201 +AMD1 : 201 CSV  I EC 201 P I XEL I EC/TR 60788:2004, rm-32-60 P RI MARY PROTECTI VE SHI ELDI NG I EC 60601 -1 -3: 2008, 3.47 P ROCESS I EC 60601 -1 : 2005/AMD1 : 201 2, 89 P ROTECTI VE BARRI ER I EC 60601 -1 -3: 2008, 49 P ROTECTI VE EARTH CONDU CTOR I EC 60601 -1 : 2005, 93 Q UALI TY EQUI VALENT FI LTRATI ON I EC 60601 -1 -3: 2008, 3.52 R ADI ATI ON I EC 60601 -1 -3: 2008, 3.53 R ADI ATI ON DETECTOR I EC 60601 -1 -3: 2008, 3.57 R ADI ATI ON PROTECTI ON I EC 60601 -1 -3: 2008, 3.59 R ADI ATI ON QUALI TY I EC 60601 -1 -3: 2008, 60 R ADI OGRAPHI C RATI N G I EC 60601 -1 -3: 2008, 63 R ADI OGRAPHY I EC 60601 -1 -3: 2008, 64 R AW DATA 201 3.209 R EADY STATE I EC/TR 60788:2004, rm -84-05 R EFERENCE AXI S I EC/TR 60788: 2004, rm -37-03 R ESI DUAL RADI ATI ON I EC 60601 -1 -3: 2008, 72 R ESPONSI BLE ORGANI SATI ON I EC 60601 -1 : 2005, 01 R I SK I EC 60601 -1 : 2005/AMD1 :201 2,3 02 R I SK MANAGEMENT I EC 60601 -1 : 2005/AMD1 :201 2, 07 R I SK MANAGEMENT FI LE I EC 60601 -1 : 2005/AMD1 : 201 2, 08 S CATTERED RADI ATI ON I EC 60601 -1 -3: 2008, 73 S I GNI FI CANT ZONE OF OCCUPANCY I EC 60601 -1 -3: 2008, 3.74 S I NGLE FAULT CON DI TI ON I EC 60601 -1 : 2005/AMD1 :201 2, 1 S TRAY RADI ATI ON I EC 60601 -1 -3: 2008, 75 S UPPLY MAI NS I EC 60601 -1 : 2005, 20 T ARGET I EC/TR 60788:2004, rm -20-08 T EST DEVI CE I EC/TR 60788:2004, rm -71 -04 T OTAL FI LTRATI ON I EC 60601 -1 -3: 2008, 3.77 T RAPPI NG ZONE I EC 60601 -1 : 2005, 31 X- RADI ATI ON I EC 60601 -1 -3: 2008, 3.53 X- RAY BEAM I EC 60601 -1 -3: 2008, 3.55 X- RAY EQUI PMENT I EC 60601 -1 -3: 2008, 3.78 X- RAY FI ELD I EC 60601 -1 -3: 2008, 3.58 X- RAY GENERATOR I EC 60601 -1 -3: 2008, 3.79 X- RAY I MAGE RECEPTOR I EC 60601 -1 -3: 2008, 3.81 X- RAY PATTERN I EC 60601 -1 -3: 2008, 3.82 X- RAY SOURCE ASSEMBLY I EC 60601 -1 -3: 2008, 62 X- RAY TUBE I EC 60601 -1 -3: 2008, 83 X- RAY TUBE ASSEMBLY I EC 60601 -1 -3: 2008, 3.84 X- RAY TUBE CURRENT I EC 60601 -1 -3: 2008, 85 X- RAY TUBE LOAD I EC 60601 -1 -3: 2008, 3.87 X- RAY TUBE VOLTAGE I EC 60601 -1 -3: 2008, 3.88 Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn Copyright International Electrotechnical Commission C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn Copyright International Electrotechnical Commission C.vT.Bg.Jy.Lj.Tai lieu Luan vT.Bg.Jy.Lj van Luan an.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj Do an.Tai lieu Luan van Luan an Do an.Tai lieu Luan van Luan an Do an Stt.010.Mssv.BKD002ac.email.ninhd.vT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.LjvT.Bg.Jy.Lj.dtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn.Stt.010.Mssv.BKD002ac.email.ninhddtt@edu.gmail.com.vn.bkc19134.hmu.edu.vn