BS EN 60601-2-39-2008 Medical electrical equipment — nPart 2-39 Particular requirements for basic safety and nessential performance of peritoneal dialysis nequipment《医疗电气设备 腹膜透析设备的.pdf

1、Medical electrical equipment Part 2-39: Particular requirements for basic safety andessential performance of peritoneal dialysis equipmentBS EN 60601-2-39:2008raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI British StandardsLicensed Copy: Wang Bin

2、, ISO/EXCHANGE CHINA STANDARDS, 17/06/2009 03:09, Uncontrolled Copy, (c) BSINational forewordThis British Standard is the UK implementation of EN 60601-2-39:2008. It isidentical to IEC 60601-2-39:2007. It supersedes BS EN 60601-2-39:1999which is withdrawn.The UK participation in its preparation was

3、entrusted by Technical CommitteeCH/150, Implants for surgery, to Subcommittee CH/150/2, Cardiovascularimplants.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. User

4、s are responsible for its correct application. BSI 2008ISBN 978 0 580 56986 9ICS 11.040.99BRITISH STANDARDBS EN 60601-2-39:2008Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of the StandardsPolicy and Strategy C

5、ommittee on 31 March 2009 Amendments issued since publicationAmd. No. Date Text affectedLicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 17/06/2009 03:09, Uncontrolled Copy, (c) BSIEUROPEAN STANDARD EN 60601-2-39 NORME EUROPENNE EUROPISCHE NORM April 2008 CENELEC European Committee for Electro

6、technical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No

7、. EN 60601-2-39:2008 E ICS 11.040.99 Supersedes EN 60601-2-39:1999English version Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2007) Appareils lectromdicaux - Partie 2-39: Exigences parti

8、culires pour la scurit de base et les performances essentielles des appareils de dialyse pritonale (CEI 60601-2-39:2007) Medizinische elektrische Gerte - Teil 2-39: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Gerten (IEC 60601-2-39

9、:2007) This European Standard was approved by CENELEC on 2008-03-01. 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 bibliogra

10、phical 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

11、 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, Hu

12、ngary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 60601-2-39:2008Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 17/06/2009 03:09, Uncontrolled

13、Copy, (c) BSIEN 60601-2-39:2008 - 2 - Foreword The text of document 62D/555/CDV, future edition 2 of IEC 60601-2-39, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC Parallel Unique Acceptance Procedure and was app

14、roved by CENELEC as EN 60601-2-39 on 2008-03-01. This European Standard supersedes EN 60601-2-39:1999 + corrigendum December 1999. Major changes since EN 60601-2-39:1999 include a summary of additional essential performance requirements. The following dates were fixed: latest date by which the EN ha

15、s to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2008-12-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2011-03-01 This European Standard has been prepared under a mandate given to CENELE

16、C 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 print types are used: requirements and definitions: in roman type; test specifications: in italic type; informative material

17、 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 STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: IN SMALL CAPITALS. In referring to the structure of this standard, th

18、e 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” 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 c

19、lauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this 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

20、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 “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; “should” means that compliance

21、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. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indica

22、tes that there is guidance or rationale related to that item in Annex AA. BS EN 60601-2-39:2008Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 17/06/2009 03:09, Uncontrolled Copy, (c) BSI- 3 - EN 60601-2-39:2008 Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of th

23、e International Standard IEC 60601-2-39:2007 was approved by CENELEC as a European Standard without any modification. _ BS EN 60601-2-39:2008Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 17/06/2009 03:09, Uncontrolled Copy, (c) BSIEN 60601-2-39:2008 - 4 - Annex ZA (normative) Normative refe

24、rences to international publications with their corresponding European publications Addition to Annex ZA of EN 60601-1:2006: Publication Year Title EN/HD Year IEC 60601-1-9 2007 Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Stan

25、dard: Requirements for environmentally conscious design EN 60601-1-9 2008 IEC 60601-1-10 2007 Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers EN 60

26、601-1-10 2008 BS EN 60601-2-39:2008Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 17/06/2009 03:09, Uncontrolled Copy, (c) BSI- 5 - EN 60601-2-39:2008 Annex ZZ (informative) Coverage of Essential Requirements of EC Directives This European Standard has been prepared under a mandate given to

27、CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC. Compliance with this standard provides one means of conformity with the specified essential requi

28、rements 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 60601-2-39:2008Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 17/06/2009 03:09, Uncontrolled Copy, (c) BSI 2 60601-2-39 I

29、EC:2007 CONTENTS FOREWORD.3 201.1 Scope, object and related standards .5 201.2 Normative references 6 201.3 Terms and definitions7 201.4 General requirements8 201.5 General requirements for testing of PD EQUIPMENT.8 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 8 201.7 PD EQUIPMENT identificat

30、ion, marking and documents 8 201.8 Protection against electrical HAZARDS from PD EQUIPMENT10 201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS.10 201.10 Protection against unwanted and excessive radiation HAZARDS10 201.11 Protection against excessive temperatures and other H

31、AZARDS11 201.12 Accuracy of controls and instruments and protection against hazardous outputs11 201.13 HAZARDOUS SITUATIONS and fault conditions.13 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .13 201.15 Construction of ME EQUIPMENT .13 201.16 ME SYSTEMS 13 201.17 Electromagnetic compatibil

32、ity of ME EQUIPMENT and ME SYSTEMS .13 202 Electromagnetic compatibility Requirements and tests .13 203 General requirements for radiation protection in diagnostic X-ray equipment.14 206 Usability14 208 * General requirements, tests and guidance for alarm systems in medical electrical equipment and

33、medical electrical systems14 209 Requirements for the reduction of environmental impacts14 210 Process requirements for the development of physiologic closed-loop controllers .14 Annexes .15 Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic mixtures15 Annex AA (info

34、rmative) Particular guidance and rationale16 Index of defined terms used in this particular standard17 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 17/06/2009 03:09, Uncontrolled Copy, (c) BSI60601-2-39 IEC:2007 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Par

35、t 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). T

36、he object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Speci

37、fications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations

38、 liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters e

39、xpress, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Com

40、mittees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC Nati

41、onal Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no

42、 marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with an IEC Publication. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, se

43、rvants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publica

44、tion, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibili

45、ty that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International standard IEC 60601-2-39 has been prepared by IEC subcommittee 62D: Electromedical equipment, of IEC technical commi

46、ttee 62: Electrical equipment in medical practice. This second edition cancels and replaces the first edition of IEC 60601-2-39. It constitutes a technical revision. Major changes since the last edition include a summary of additional essential performance requirements. The text of this particular s

47、tandard is based on the following documents: Enquiry draft Report on voting 62D/555/CDV 62D/638/RVC Full information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above table. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 17

48、/06/2009 03:09, Uncontrolled Copy, (c) BSI 4 60601-2-39 IEC:2007 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material

49、 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 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 7 includes subclauses 7.1, 7.2, etc.); “subcl