EN 60601-2-29-2008 en Medical electrical equipment - Part 2-29 Particular requirements for the basic safety and essential performance of radiotherapy simulators (Incorporates Amend.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipment Part 2-29: Particular requirements for the basic safetyand essential performance of radiotherapy simulatorsBS EN 60601-2-29:2008+A11:2011BS EN 60601-

2、2-29:2008+A11:2011National forewordThis British Standard is the UK implementation of EN 60601-2-29:2008+A11:2011. It is identical to IEC 60601-2-29:2008. It supersedes BS EN 60601-2-29:2008 which will be withdrawn on 1 October 2014.The UK participation in its preparation was entrusted by Technical C

3、ommittee CH/62, Electrical equipment in medical practice, to Subcommittee CH/62/3, Equipment for radiotherapy, nuclear medicine and radiation dosimetry.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to include al

4、l the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012. Published by BSI Standards Limited 2012.ISBN 978 0 580 77312 9ICS 11.040.60Compliance with a British Standard cannot confer immunity from legal obligations.This Britis

5、h Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2009Amendments issued since publicationDate Text affected30 April 2012 Implementation of CENELEC amendment A11:2011. Modification of Annex ZZ.BRITISH STANDARDEUROPEAN STANDARD NORME EUROPENNE EURO

6、PISCHE NORMCENELEC European Committee forElectrotechnicalStandardization Comit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr Elektrotechnische NormungCentral Secretariat:rue de Stassart35, B - 1050 Brussels 2008 CENELEC - All rights of exploitation in any form and by any means rese

7、rved worldwide for CENELECmembers.Ref. No. EN 60601-2-29:2008 EICS 11.040.60English versionMedical electricalequipment - Part 2-29: Particular requirements for the basic safetyand essential performance of radiotherapy simulators(IEC 60601-2-29:2008)A ppareils lectromdicaux -Partie 2-29: Exigences pa

8、rticulires pour la scurit de base et les performances essentielles des simulateurs de radiothrapie(CEI 60601-2-29:2008)Medizinische elektrische Gerte -Teil 2-29: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Strahlentherapiesimulatoren(IEC 60601-2-29:2

9、008)This European Standard was approved by CENELEC on 2008-11-01. CENELEC members are bound to complywith the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographic

10、al references concerning such national standards may be obtained onapplication to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any otherlanguage made by translation under the responsibility of a CEN

11、ELEC member into its own language and notifiedto the Central Secretariat has the same status as the official versions.CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, theCzech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ic

12、eland, Ireland, Italy, Latvia,Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.EN 60601-2-29:October 20112008+A11Foreword The text of document 62C/423/CDV, future edition 3 of IEC 60601-2-29, prepa

13、red bySC 62C, Equipmentfor radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC 62, Electrical equipment in medicalpractice, was submitted to the IEC-CENELEC p arallel Unique Acceptance Procedure and wasapprovedby CENELEC asEN 60601-2-29 on 2008-11-01.This European Standard supersedes E

14、N 60601-2-29:1999. EN 60601-2-29:2008 constitutes a technical r evision, which brings EN60601-2-2 9 in line withEN 60601-1:2006 and its collateral standards.The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identicalnational stan

15、dard or by endorsement (dop) 2009-08-01 latest date by which the national standards conflictingwith the EN have to be withdrawn (dow) 2011-11-01This European Standardhas been prepared under a mandate given to CENELEC by the EuropeanCommission and the European Free Trade Association and covers essent

16、ial requirements of EC Directive 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. Normati

17、ve text oftables is also in a smaller type. T ERMS DEFINED IN C LAUSE 3 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,inclu

18、sive of allsubdivisions (e.g. Clause 7 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 ofClause7).References to clauses within this standard are preceded by the term “Clause” followed by the clausenumber. Reference

19、s 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 combinationof the conditions is true.The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Direct

20、ives,Part 2. For the purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with thisstandard; “should” means that compliance with a requirement or a test is recommended but is not mandatory forcompliance with this standa

21、rd; “may”is used to describe a permissible way to achieve compliance with a requirement or test. An asterisk(*) as the first character of a title or at the beginning of a paragraph or table title indicates thatthere is guidance or rationale related to that item in Annex AA.Annexes ZA and ZZ have bee

22、n added by CENELEC._BS EN 60601-2-29:2008+A11:2011 EN 60601-2-29:2008+A11:2011 (E) - 2 -Endorsement noticeThe textofthe International Standard IEC 60601-2-29:2008 was approved by CENELEC asa European Standard without any modification.In the official version, for Bibliography, the following notes hav

23、e to be added for the standards indicated:IEC 60601-1-3 NOTE Harmonized as EN 60601-1-3:2008 (not modified).IEC 60601-1-8 NOTE Harmonized as EN 60601-1-8:2007 (not modified).IEC 60601-2-1 NOTE Harmonized as EN 60601-2-1:1998 (not modified)._This document (EN 60601-2-29:2008/A11:2011) has been prepar

24、ed by CLC/TC 62 “Electrical equipment in medical practice”. The following dates are fixed: latest date by which this document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2012-10-01 latest date by which the national standards confli

25、cting with this document have to be withdrawn (dow) 2014-10-01 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. Foreword to amendment A

26、11BS EN 60601-2-29:2008+A11:2011 EN 60601-2-29:2008+A11:2011 (E)- 3 -A nnex ZA(normative)Normative references to international publicationswith their corresponding European publications Addition to Annex ZA of EN 60601-1:2006:Publication Year Title EN/HD YearIEC/TR60788 2004 Medical electrical equip

27、ment -Glossary of defined terms - - IEC 61217 - 1) Radiotherapy equipment -Coordinates, movements and scalesEN 6121719962)1) Undated reference.2) Valid edition at date of issue.BS EN 60601-2-29:2008+A11:2011 EN 60601-2-29:2008+A11:2011 (E) - 4 -Annex ZZ (informative) Coverage of Essential Requiremen

28、ts 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 fo

29、llows: Essential Requirement 6a Essential Requirement 7.4 Essential Requirement 7.5 paragraph 2 4 to 6;19, ofdirections 9 to 12; 16 to 18 and of dimensions 14; 15 (see accompanying table)17Figure 103 Equipment movements and scales View from RADIATION SOURCE ofTELERADIOTHERAPY RADIATION FIELD or RADI

30、OTHERAPY SIMULATOR DELINEATED RADIATION FIELD (see accompanying table)18Table 201.101 Description of equipment movements .19Table 201.C.101 ACCOMPANYING DOCUMENTS, General .22Table 201.C.102 ACCOMPANYING DOCUMENTS, Instructions for use22Table 201.C.103 A CCOMPANYING DOCUMENTS, technical description2

31、BS EN 60601-2-29:2008+A11:2011 EN 60601-2-29:2008+A11:2011 (E) - 6 -2INTRODUCTION This particular standard establishes requirements to be complied with by MANUFACTURERS inthe design andconstruction of RADIOTHERAPY SIMULATORS; it does notattempt to define the iroptimum performance requirements. Itspu

32、rpose is to identify those features of design that areregarded, at the present time, as essential for the safe operation of such ME EQUIPMENT. Itplaces limitson the degradation of ME EQUIPMENT performance beyond which itcan bepresumed that a fault condition exists, for example a component failure, a

33、nd where an INTERLOCK then operates to prevent continued operation of the MEEQUIPMENT. BS EN 60601-2-29:2008+A11:2011 EN 60601-2-29:2008+A11:2011 (E)- 7 -MEDICAL ELECTRICAL EQUIPMENT Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators201.1Scop

34、e, object and related standards Clause 1 ofthe generalstandard 1) applies, except asfo llows: 201.1.1 ScopeReplacement: This International Standard applie sto the BASIC SAFETY and ESSENTIAL PERFORMANCE ofRADIOTHERAPY SIMULATORS, hereafter referred toas ME EQUIPMENT . If a clause or subclause is spec

35、ificallyintended t o be applicable to ME EQUIPMENT only, orto ME SYSTEMS only, the title and content of that clause or subclause will say so. If that isnot the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS , as relevant. H AZARDS inherent in the intended physiological

36、function of ME EQUIPMENT or ME SYSTEMSwithin the scope of this standard are not covered by specific requirements in this standardexcept in 7.2.13 and 8.4.1 ofthe general standard.NOTE See also 4.2 of the general standard.201.1.2 ObjectReplacement: The object of this particular standard is to establi

37、shparticular BASIC SAFETY and ESSENTIALPERFORMANCE requirements for RADIOTHERAPY SIMULATORS as defined in 201.3.204.201.1.3 *CollateralstandardsAddition:This particular standard refers to those applicable collateral standards that are listed in Clause 2 ofthe generalstandard and Clause 2 of this par

38、ticularstandard. The following collateral standard doesnot apply: IEC60601-1-10.201.1.4 Particular standardsReplacement:In the IEC60601 series, particular standards may modify, replace or delete requirementscontained in the general standard and collateral standards asappropriate for the particular 1

39、) The general standard is IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance BS EN 60601-2-29:2008+A11:2011 EN 60601-2-29:2008+A11:2011 (E) - 8 -ME EQUIPMENT under consideration, and ma y add other BASIC SAFETY and ESSENTIALPERFORMA

40、NCE requirements.Arequirement of a particularstandard takes priority overthe general standard.For brevity, IEC60601-1 is referred to in this particular standard as the general standard. Collateral standardsare referred to bytheir document num ber. The numbering of sections, clauses and subclauses of

41、 this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses thecontent of Clause 1 of the general standard) orapplicable collateral standard with the prefix“20x”where x is the final digit(s) of the collateral standard document nu

42、mber (e.g. 202.4inthis particular standard addresses the content of Clause 4 of the60601-1-2 collateral standard, 203.4 in thisparticular standard addresses the content of Clause4 ofthe 60601-1-3collateral standard, etc.). The changes to thetextof the general standardare specifiedbythe use of the fo

43、llowing words:“Replacement“ means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particularstandard.“Addition“ means that the text of this particular standard is additional to the requirements ofthegeneral standard or

44、 applicable collateral standard.“Amendment“ means that the clause or subclause of the general standard or applicablecollateralstandard is amended as indicated by the text ofthis particular standard.Subclauses or figures which are additional to thoseof the general standard are numberedstarting from 2

45、01.101. However due to the fact that definitions in the general standard arenumbered 3.1 through 3.139, additional definitions in this standard are numbered beginning from 201.3.201.Additional annexes areletteredAA, BB, etc., and additional items aa), bb) ,etc.Subclauses or figures which areaddition

46、al tothose ofa collateral standard are numberedstarting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc.The term “this standard“ is used to make referencetothe general standard, anyapplicablecollateral standards and this particular

47、 standard taken together. Wherethere is no corresponding section,clause or subclause in this particular standard, the section, clause or subclause of the general standard or applicable collateral standard,although possibly notrelevant,applies withoutmodification; whereitis intended that any part of

48、the general standard or applicable collateral standard, although possiblyrelevant, is not to be applied, a statement to that effect isgiven in this particularstandard.201.2 NormativereferencesClause 2 ofthe generalstandard applies, except asfollows:Addition:IEC TR 60788:2004, Medical electrical equi

49、pment Glossary ofdefined termsIEC 61217, Radiotherapy equipment Coordinates, movements and scalesBS EN 60601-2-29:2008+A11:2011 EN 60601-2-29:2008+A11:2011 (E)- 9 -201.3Terms and definitionsFor the purposes ofthis document, the terms and definitions given in IEC 60601-1:2005 andIEC TR 60788:2004 apply,except as follows:NOTE An index of defined terms is found beginning on page 23.Addition:201.3.201DELINEATED RADIATION BEAMthat part of the RADIATION BEAM borderedbythe shadow cast by the DELINEATORS20