1、BSI Standards PublicationMedical electrical equipmentPart 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipmentBS EN 60601-2-16:2015National forewordThis British Standard is the UK implementation of EN 60601-2-
2、16:2015. It isidentical to IEC 60601-2-16:2012. It supersedes BS EN 60601-2-16:1998which is withdrawn.The UK participation in its preparation was entrusted by TechnicalCommittee CH/150, Implants for surgery, to Subcommittee CH/150/2,Cardiovascular implants.A list of organizations represented on this
3、 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 2015ISBN 978 0 580 78907 6ICS 11.
4、040.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 60601-2-16
5、:2015EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 60601-2-16 June 2015 ICS 11.040.20; 11.040.25 Supersedes EN 60601-2-16:1998 English Version Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and
6、 haemofiltration equipment (IEC 60601-2-16:2012) Appareils lectromdicaux - Partie 2-16: Exigencesparticulires pour la scurit de base et les performancesessentielles des appareils dhmodialyse,dhmodiafiltration et dhmofiltration (IEC 60601-2-16:2012) Medizinische elektrische Gerte - Teil 2-16: Besonde
7、reFestlegungen fr die Sicherheit einschlielich derwesentlichen Leistungsmerkmale von Hmodialyse-, Hmodiafiltrations- und Hmofiltrationsgerten (IEC 60601-2-16:2012) This European Standard was approved by CENELEC on 2015-04-14. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulati
8、ons 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 or to any CENELEC memb
9、er. 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 as the official version
10、s. 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, Luxembourg, Malta, the N
11、etherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management
12、 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 60601-2-16:2015 E Foreword The text of document 62D/972/FDIS, future edition 4 of IEC 60601-2-16, prepared by SC 62D, “Electromedical eq
13、uipment“, of IEC TC 62, “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-16:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical nat
14、ional standard or by endorsement (dop) 2016-01-14 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-04-14 This document supersedes EN 60601-2-16:1998. Attention is drawn to the possibility that some of the elements of this document may be the s
15、ubject 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 European Free Trade Association, and supports essential requirements of EU Dire
16、ctive(s). For the relationship with EU Directive see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standard IEC 60601-2-16:2012 was approved by CENELEC as a European Standard without any modification. In the official version, for B
17、ibliography, the following notes have to be added for the standards indicated: IEC 60601-2-16:1998 NOTE Harmonized as EN 60601-2-16:1998 (not modified). IEC 60601-2-39 NOTE Harmonized as EN 60601-2-39. ISO 11197 NOTE Harmonized as EN ISO 11197. BS EN 60601-2-16:2015 EN 60601-2-16:2015 (E)Annex ZA (n
18、ormative) Normative references to international publications with their corresponding European publications The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For u
19、ndated 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 by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information on the latest versions of the Europea
20、n Standards listed in this annex is available here: www.cenelec.eu. Annex ZA of EN 60601-1:2006 applies with the following exceptions: Publication Year Title EN/HD Year Replacement : IEC 60601-1-2 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential perfo
21、rmance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 + corr March 2007 2010 IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability EN 60601-1-6 2010 IEC
22、60601-1-8 2006 Medical electrical 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 + corr March 2007 2010
23、 Addition: 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 60601-1-10 2008 IEC 60601-1-11 2010 Medical electrical equipment
24、- Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment EN 60601-1-11 2010 IEC 62366 2007 Medical devices - Application of usability engine
25、ering to medical devices EN 62366 2008 BS EN 60601-2-16:2015 EN 60601-2-16:2015 (E)ISO 594-2 - Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings ISO 3744 - Acoustics - Determination of sound power levels and sound energy levels o
26、f noise sources using sound pressure - Engineering methods for an essentially free field over a reflecting plane EN ISO 3744 - ISO 8638 - Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters EN ISO 8638 - BS EN 60601-2
27、-16:2015 EN 60601-2-16:2015 (E)Annex ZZ (informative) Coverage of Essential 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 relevan
28、t essential requirements given in Annex I of EU Directive 93/42/EEC of 14 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
29、 be applied to the products falling within the scope of this standard. BS EN 60601-2-16:2015 EN 60601-2-16:2015 (E) 2 60601-2-16 IEC:2012 CONTENTS FOREWORD. 3 INTRODUCTION . 6 201.1 Scope, object and related standards 7 201.2 Normative references 9 201.3 Terms and definitions 10 201.4 General requir
30、ements 12 201.5 General requirements for testing of ME EQUIPMENT 15 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 16 201.7 ME EQUIPMENT identification, marking and documents . 16 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 19 201.9 Protection against MECHANICAL HAZARDS of
31、 ME EQUIPMENT and ME SYSTEMS . 20 201.10 Protection against unwanted and excessive radiation HAZARDS . 21 201.11 Protection against excessive temperatures and other HAZARDS . 21 201.12 * Accuracy of controls and instruments and protection against hazardous outputs 22 201.13 HAZARDOUS SITUATIONS and
32、fault conditions 30 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 31 201.15 Construction of ME EQUIPMENT 31 201.16 * ME SYSTEMS 32 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 33 202 Electromagnetic compatibility Requirements and tests . 33 208 General requirements
33、, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems . 33 210 Process requirements for the development of PHYSIOLOGIC CLOSED-LOOP CONTROLLERS . 35 211 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS used in the HOME HEAL
34、THCARE ENVIRONMENT . 35 Annexes . 35 Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic mixtures . 36 Annex AA (informative) Particular guidance and rationale . 37 Annex BB (informative) Examples of HAZARDS, foreseeable sequences of events, and HAZARDOUS SITUATIONS i
35、n HAEMODIALYSIS EQUIPMENT . 55 Bibliography . 63 Index of defined terms used in this particular standard 64 Figure 201.101 Continuous air infusion test set-up with example dimensions 28 Figure AA.1 Example of the HAEMODIALYSIS ME SYSTEM . 51 Table 201.101 ESSENTIAL PERFORMANCE requirements . 12 Tabl
36、e AA.1: Possible ALARM CONDITION priorities according to 6.1.2 of IEC 60601-1-8:2006, . 53 Table BB.1 Hazardous situation list following ISO 14971:2007, Annex E . 55 BS EN 60601-2-16:2015 EN 60601-2-16:2015 (E)60601-2-16 IEC:2012 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIP
37、MENT Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotec
38、hnical committees (IEC National Committees). 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 Specification
39、s, Technical Reports, Publicly Available 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, g
40、overnmental and non-governmental organizations 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 decisio
41、ns or agreements of IEC on technical 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 internat
42、ional use and are accepted by IEC National 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
43、 to promote international uniformity, 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 clear
44、ly indicated in the latter. 5) IEC 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 bo
45、dies. 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, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, proper
46、ty damage or other damage of any nature 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 th
47、is publication. Use of the referenced 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 o
48、r all such patent rights. International standard IEC 60601-2-16 has been prepared by IEC subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This fourth edition cancels and replaces the third edition of IEC 60601-2-16, published in 200
49、8. This edition constitutes a technical revision. Changes since the previous edition include, among others, better adaptation of IEC 60601-1-8 and improvement of subclause 201.8.3. BS EN 60601-2-16:2015 EN 60601-2-16:2015 (E) 4 60601-2-16 IEC:2012 The text of this particular standard is based on the following documents: FDIS Report on voting 62D/972/FDIS 62D/987/RVD Full information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above t
