1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipmentPart 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosisBS EN 60601-2-28:2010N
2、ational forewordThis British Standard is the UK implementation of EN 60601-2-28:2010. It isidentical to IEC 60601-2-28:2010. It supersedes BS EN 60601-2-28:1993,which will be withdrawn on 1 April 2013.The UK participation in its preparation was entrusted by Technical CommitteeCH/62, Electrical Equip
3、ment in Medical Practice, to Subcommittee CH/62/2,Diagnostic imaging equipment.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions of acontract. Users are responsible for its correc
4、t application. BSI 2010ISBN 978 0 580 61684 6ICS 11.040.55Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of the StandardsPolicy and Strategy Committee on 31 July 2010.Amendments issued since publicationAmd. No.
5、Date Text affectedBRITISH STANDARDBS EN 60601-2-28:2010EUROPEAN STANDARD EN 60601-2-28 NORME EUROPENNE EUROPISCHE NORM May 2010 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Management
6、Centre: Avenue Marnix 17, B - 1000 Brussels 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-28:2010 E ICS 11.040.55 Supersedes EN 60601-2-28:1993English version Medical electrical equipment - Part 2-28: Particular req
7、uirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (IEC 60601-2-28:2010) Appareils lctromdicaux - Partie 2-28: Exigences particulires pour la scurit de base et les performances essentielles des gaines quipes pour diagnostic mdical (CEI 60601-2-28:
8、2010) Medizinische elektrische Gerte - Teil 2-28: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Rntgenstrahlern fr die medizinische Diagnostik (IEC 60601-2-28:2010) This European Standard was approved by CENELEC on 2010-04-01. CENELEC members are bound
9、 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 Cen
10、tral 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 s
11、tatus as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands
12、, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 60601-2-28:2010EN 60601-2-28:2010 - 2 - Foreword The text of document 62B/778/FDIS, future edition 2 of IEC 60601-2-28, prepared by SC 62B, Diagnostic imaging equipment, of IEC TC 62, El
13、ectrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-28 on 2010-04-01. This European Standard supersedes EN 60601-2-28:1993. The second edition of this particular standard has been prepared to fit EN 60601-1:2006, which is r
14、eferred to as the general standard. When the first edition was developed, mainly X-RAY TUBE ASSEMBLIES holding a glass insert were considered and EN 60601-1:1990 was in place. While the variety of modern X-RAY TUBE ASSEMBLIES and technologies has increased, the third edition of the general standard
15、requires the MANUFACTURER to perform RISK MANAGEMENT. The technical modifications versus the first edition of EN 60601-2-28 account for these changes. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and CENELEC shall not be he
16、ld responsible for identifying any or all such patent rights. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2011-01-01 latest date by which the national standards conflictin
17、g with the EN have to be withdrawn (dow) 2013-04-01 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 93/42/EEC. See Annex ZZ. In this standard, the following
18、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 3 OF THE GENERAL ST
19、ANDARD, 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 7 includes subclauses 7.1, 7.2, etc.); “subclause”
20、 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 standar
21、d, 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 2. For the purposes of this standard, the auxiliary verb: BS EN 60601
22、-2-28:2010- 3 - EN 60601-2-28:2010 “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
23、 permissible way to achieve compliance with a requirement or test. Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-2-28:2010 was approved by CENELEC as a European Standard without any modification. _ BS EN 60601-2-28:2010EN 60601-2-
24、28:2010 - 4 - Annex ZA (normative) Normative references to international publications with their corresponding European publications The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references
25、, the latest edition of the referenced document (including any amendments) applies. NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Y
26、ear Replacement: IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment EN 60601-1-3 + corr. March 2008 2010 Addition: IEC 60336 - Medical electrical equipme
27、nt - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots EN 60336 - IEC 60522 - Determination of the permanent filtration of X-ray tube assemblies EN 60522 - IEC 60613 2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis EN 60613 2010 IE
28、C/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - BS EN 60601-2-28:2010- 5 - EN 60601-2-28:2010 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 a
29、nd the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned.
30、WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard. BS EN 60601-2-28:2010 2 60601-2-28 IEC:2010 CONTENTS 201.1 Scope, object and related standards5 201.2 Normative references 6 201.3 Terms and definitions 7 201.4 General re
31、quirements7 201.5 General requirements for testing ME EQUIPMENT.7 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 8 201.7 ME EQUIPMENT identification, marking and documents8 201.8 Protection against electrical HAZARDS from ME EQUIPMENT10 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMEN
32、T and ME SYSTEMS11 201.10 Protection against unwanted and excessive radiation HAZARDS12 201.11 Protection against excessive temperatures and other HAZARDS12 201.12 Accuracy of controls and instruments and protection against hazardous outputs .13 201.13 HAZARDOUS SITUATIONS and fault conditions.13 20
33、1.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .13 201.15 Construction of ME EQUIPMENT .13 201.16 ME SYSTEMS.13 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS13 203 RADIATION protection in diagnostic X-RAY EQUIPMENT .13 Annexes .14 Annex AA (informative) Test of X-RAY TUBE
34、ASSEMBLIES for pressure-related RISKS.15 Index of defined terms used in this particular standard17 BS EN 60601-2-28:201060601-2-28 IEC:2010 5 MEDICAL ELECTRICAL EQUIPMENT Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
35、201.1 Scope, object and related standards Clause 1 of the general standard1)applies, except as follows: 201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY TUBE ASSEMBLIES and to components thereof: hereafter referred to as ME EQUIPME
36、NT; intended for medical diagnosis and imaging. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT
37、 and to ME SYSTEMS, as relevant. NOTE This International Standard is also applicable to the X-RAY TUBE ASSEMBLY aspects of X-RAY SOURCE ASSEMBLIES and X-RAY TUBE HEADS. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANC
38、E requirements for X-RAY TUBE ASSEMBLIES for medical diagnosis. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard. IEC 60601-1-3 applies as m
39、odified in Clause 203. IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-10 and IEC 60601-1-11 do not apply. All other published collateral standards in the IEC 60601-1 series apply as published. NOTE 101 IEC 60601-1-2 does not apply because RISKS for the X-RAY TUBE ASSEMBLY ou
40、tside the system may only be indicative of RISKS for the system due to the difference in electromagnetic environment. NOTE 102 IEC 60601-1-6 and IEC 60601-1-8 do not apply because X-RAY TUBE ASSEMBLIES are not operated as a stand-alone device. NOTE 103 X-RAY TUBE ASSEMBLIES are not in the scope of I
41、EC 60601-1-10 and IEC 60601-1-11. 1)The general standard is IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance. BS EN 60601-2-28:2010 6 60601-2-28 IEC:2010 201.1.4 Particular standards Replacement: In the IEC 60601 series, particula
42、r standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes pr
43、iority over the general standard. For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this particular standard corresponds to that of the general standar
44、d with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the conte
45、nt of Clause 4 of the 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words: “Replacement” means that the clause o
46、r subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard. “Addition” means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard. “Amendment” me
47、ans that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard. Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However due to the fact
48、that definitions in the general standard are numbered 3.1 through 3.139, additional definitions in this standard are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Subclauses, figures or tables which are additional to those of a c
49、ollateral standard are numbered starting 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 reference to the general standard, any applicable collateral standards and this particular standard taken together. Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, alt
