BS EN 60601-2-23-2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment《医疗.pdf

1、BSI Standards PublicationMedical electrical equipmentPart 2-23: Particular requirements for basic safety and essential performance of transcutaneous partial pressure monitoring equipmentBS EN 60601-2-23:2015National forewordThis British Standard is the UK implementation of EN 60601-2-23:2015. It is

2、identical to IEC 60601-2-23:2011. It supersedes BS EN 60601-2-23:2000, which will be withdrawn on 15 September 2018.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/4, Electromedical equipment.A list of

3、organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited

4、2015ISBN 978 0 580 60663 2ICS 11.040.55Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 November 2015.Amendments/corrigenda issued since publicationDate Text aff

5、ectedBRITISH STANDARDBS EN 60601-2-23:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-23 October 2015 ICS 11.040.55 Supersedes EN 60601-2-23:2000 English Version Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of trans

6、cutaneous partial pressure monitoring equipment (IEC 60601-2-23:2011) Appareils lectromdicaux - Partie 2-23: Exigences particulires pour la scurit de base et les performances essentielles des appareils de surveillance de la pression partielle transcutane (IEC 60601-2-23:2011) Medizinische elektrisch

7、e Gerte - Teil 2-23: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Gerten fr die transkutane Partialdruckberwachung (IEC 60601-2-23:2011) This European Standard was approved by CENELEC on 2015-09-15. CENELEC members are bound to comply with the CEN/CEN

8、ELEC 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-CENELEC Management Centre

9、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 CEN-CENELEC Management Centre has the same status a

10、s the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Lu

11、xembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung

12、 CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 60601-2-23:2015 E BS EN 60601-2-23:2015EN 60601-2-23:2015 2 European foreword The text of document 62D/885/FDIS,

13、future edition 3 of IEC 60601-2-23, prepared by SC 62D “Electromedical equipment“, of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-23:2015. The following dates are fixed: latest date by which the document ha

14、s to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-06-15 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-09-15 This document supersedes EN 60601-2-23:2000. Attention is drawn to

15、 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. This document has been prepared under a mandate given to CENELEC by the European Commission and the Europea

16、n Free Trade Association, and supports essential requirements of EU Directive(s). For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standard IEC 60601-2-23:2011 was approved by CENE

17、LEC as a European Standard without any modification. BS EN 60601-2-23:2015EN 60601-2-23:2015 3 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in whole or in part, are normatively referenced in this docum

18、ent and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE 1 When an International Publication has been modified by common modifications, indicated

19、 by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here: www.cenelec.eu. Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year Replacement in Annex ZA of EN 60601-

20、1:2006: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 2007 - - + corrigendum Mar. 2010 IEC 60601-1-8 2006 Medical electrical

21、equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems EN 60601-1-8 2007 - - + corrigendum Mar. 2010 Addition to Annex ZA of

22、 EN 60601-1:2006: IEC 60601-2-49 2011 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment EN 60601-2-49 2015 BS EN 60601-2-23:2015EN 60601-2-23:2015 4 Annex ZZ (informative) Coverage of Essenti

23、al Requirements of EU 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 given in Annex I of EU Directive 93/42/EEC of 14

24、 June 1993 concerning medical devices. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EU Directives can be applied to the products falling within the scope of this standard. BS

25、 EN 60601-2-23:2015 2 60601-2-23 IEC:2011 CONTENTS FOREWORD . 4 INTRODUCTION . 7 201.1 Scope, object and related standards . 8 201.2 Normative references 10 201.3 Terms and definitions 10 201.4 General requirements . 11 201.5 General requirements for testing of ME EQUIPMENT 11 201.6 Classification o

26、f ME EQUIPMENT and ME SYSTEMS 12 201.7 ME EQUIPMENT identification, marking and documents . 12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 13 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14 201.10 Protection against unwanted and excessive radiation

27、 HAZARDS . 14 201.11 Protection against excessive temperatures and other HAZARDS . 14 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 18 201.13 HAZARDOUS SITUATIONS and fault conditions 23 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23 201.15 Constr

28、uction of ME EQUIPMENT . 23 201.16 ME SYSTEMS 23 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 24 202 Electromagnetic compatibility Requirements and tests . 24 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrica

29、l systems . 28 Annexes . 34 Annex AA (informative) Particular guidance and rationale 35 Annex BB (informative) Alarm diagrams of Clause 208/IEC 60601-1-8:2006 43 Index of defined terms used in this particular standard 46 Figure 201.101 TRANSDUCER cable strain relief test 14 Figure 201.102 Foam block

30、 test (see 201.11.1.2.2.104 and 201.11.1.2.2.105) . 15 Figure 201.103 Linearity and hysteresis test set-up Gas mix chamber, assembled 20 Figure 201.104 Linearity and hysteresis test set-up Gas mix chamber, manufacturing dimensions 21 Figure 201.105 Linearity and hysteresis test set-up Gas mix chambe

31、r, dimensions of hose connector . 22 Figure 202.101 Set-up for radiated and conducted EMISSIONS testing according to 202.6.1.1.2 a) . 25 Figure 202.102 Set-up for radiated immunity test according to 202.6.2.3.2 27 Figure BB.1 NON-LATCHING ALARM SIGNALS without ALARM RESET . 43 Figure BB.2 NON-LATCHI

32、NG ALARM SIGNALS with ALARM RESET . 43 Figure BB.3 LATCHING ALARM SIGNALS with ALARM RESET . 44 Figure BB.4 Two ALARM CONDITIONS with ALARM RESET 44 BS EN 60601-2-23:201560601-2-23 IEC:2011 3 Table 201.101 Distributed ESSENTIAL PERFORMANCE requirements 11 Table 201.102 Required readings and toleranc

33、es 19 Table 201.103 Calibration test gases . 19 Table 208.101 ALARM CONDITION priorities 29 Table 208.102 Characteristics of the burst of auditory ALARM SIGNALS 30 BS EN 60601-2-23:2015 4 60601-2-23 IEC:2011 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-23: Particul

34、ar requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Com

35、mittees). The 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 Avai

36、lable Specifications (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 or

37、ganizations 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 technica

38、l matters express, 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 N

39、ational Committees 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 uniformit

40、y, IEC National 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

41、itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure th

42、at they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants 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 na

43、ture whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, 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 referenc

44、ed publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility 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. Internati

45、onal standard IEC 60601-2-23 has been prepared by IEC subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This third edition cancels and replaces the second edition published in 1999 and constitutes a technical revision. This edition o

46、f IEC 60601-2-23 was revised to align structurally with the 2005 edition of IEC 60601-1. BS EN 60601-2-23:201560601-2-23 IEC:2011 5 The text of this particular standard is based on the following documents: FDIS Report on voting 62D/885/FDIS 62D/907/RVD Full information on the voting for the approval

47、 of this particular standard can be found in the report on voting indicated in the above table. 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: it

48、alic 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 STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the st

49、ructure 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” 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 s