EN 60601-2-39-2008 en Medical electrical equipment - Part 2-39 Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (Incorporates Ame.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipment Part 2-39: Particular requirements for basic safety andessential performance of peritoneal dialysis equipmentBS EN 60601-2-39:2008+A11:2011National f

2、orewordBRITISH STANDARDBS EN 60601-2-39:2008+A11:2011This British Standard is the UK implementation of It is IEC 60601-2-39:2007. It supersedes BS EN 60601-2-39:2008 which will be withdrawnThe UK participation in its preparation was entrusted by Technical CommitteeCH/150, Implants for surgery, to Su

3、bcommittee CH/150/2, Cardiovascularimplants.A list of organizations represented on this subcommittee 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 correct application. ISBN 978 0 580 IC

4、S 11.040.99Compliance 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 March 2009Amendments/ corrigendum issued since publicationDate Text affectedon 1 October 2014.The Bri

5、tish Standards Institution 2012. Published by BSI Standards77314 3Implementation of CENELEC31 March 2012amendment A11:2011: Annex ZZ replacedLimited 2012.EN 60601-2-39:2008+ A11:2011. identical toEUROPEAN STANDARD EN 60601-2-39:200NORME EUROPENNE EUROPISCHE NORMCENELEC European Committee forElectrot

6、echnicalStandardization 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 reserved worldwide for CENELECmembers.Ref. No. EN 606

7、01-2-39:2008 EICS 11.040.99 Supersedes EN 60601-2-39:2008English versionMedical electricalequipment - Part 2-39: Particular requirements for basic safetyand essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2007)A ppareils lectromdicaux -Partie 2-39: Exigences particulires pour

8、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 60601-2-39:2007)This Europe

9、an Standard was approved by CENELEC on 2008-03-01. 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 bibliographical references c

10、oncerning 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 CENELEC member int

11、o 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, Iceland, Ireland,

12、 Italy, Latvia,Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.8+A11October 2011Foreword The text of document 62D/555/CDV, future edition 2 of IEC 60601-2-39, prepared by SC 62D, Electromedical eq

13、uipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to theIEC-CENELEC Parallel Unique Acceptance Procedure and was approved by CENELEC asEN 60601-2-39 on 2008-03-01.This European Standard supersedes EN 60601-2-39:1999 + corrigendum December 1999.Major changes since EN 6060

14、1-2-39:1999 include a summary of additional essential performancerequirements.The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identicalnational standard or by endorsement (dop) 2008-12-01 latest date by which the national stand

15、ards conflictingwith the EN have to be withdrawn (dow) 2011-03-01This European Standardhas been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements ofEC Directive 93/42/EEC. See Annex ZZ.In this standard, the

16、following print types are used: requirements and definitions: in roman type; testspecifications: in italic type; informative material appearing outside oftables,such as notes, examples and references: in smaller type. Normative text oftables is also in a smaller type; TERMS DEFINED IN C LAUSE 3 OF T

17、HE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: INSMALL 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 allsubdivisions (e.g. Clause 7 includes Subclauses 7.1, 7.2, etc

18、.); “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 standard are by number only.In this stan

19、dard, 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 “shall” me

20、ans 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 standard; “may”is used to describe a permissible way to achieve compliance with a re

21、quirement or test. An asterisk(*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA.BS EN 60601-2-39:2008+A11:2011 EN 60601-2-39:2008+A11:2011 (E) 2 Annexes ZA and ZZ have been added by C

22、ENELEC._Endorsement noticeThe text of the International Standard IEC 60601-2-39:2007 wasapproved byCENELEC as a European Standard without any modification._Foreword to Amendment A11 This document (EN 60601-2-39:2008/A11:2011) has been prepared by CLC/TC 62 “Electrical equipment in medical practice”.

23、 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 conflicting with this document have to be withdrawn (dow) 2014-10

24、-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. BS EN 60601-2-39:2008+A11:2011 EN 60601-2-39:2008+A11:2011 (E) 3 A nnex ZA(normati

25、ve)Nor mative references to international publicationswith their corresponding European publications Addition to Annex ZA of EN 60601-1:2006:Publication Year Title EN/HD YearIEC 60601-1-92007 Medical electrical equipment -Part 1-9: General requirements for basicsafety and essential performance - Col

26、lateral Standard: Requirements for environmentallyconscious designEN 60601-1-92008IEC 60601-1-10 2007Medical electrical equipment -Part 1-10: General requirements for basicsafety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllersE

27、N 60601-1-10 2008BS EN 60601-2-39:2008+A11:2011 EN 60601-2-39:2008+A11:2011 (E) 4 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 and the European Free Trade Association an

28、d within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC except as follows: Essential Requirement 6a Essential Requirement 7.4 Essential Requirement 7.5 paragraph 2 whereitis intended that any part of the general standard or applica

29、ble 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:BS EN 60601-2-39:2008+A11:2011 EN 60601-2-39:2008+A11:2011 (E) 8 IEC 6060

30、1-1-9:2007, Medical electrical equipment Part 1-9:General requirements for basicsafety and essential performance Collateral Sta ndard: Requirementsfo r environmentallyconscious design IEC 60601-1-10:2007, Medical electrical equipment Part 1-10:General requirements forbasic safety and essential perfo

31、rmance Collateral Standard: Requirements for thedevelopment of physiologicclosed-loop controllers201.3Terms and definitionsFor thepurposesof this document, the termsand definitions given in IEC60601-1:2005apply, except asfollow s:NOTE An index of defined terms is found beginning on page 17.Addition:

32、201.3.201APD ME EQUIPMENTME EQUIPMENT used to perform AUTOMATED PERITONEAL DIALYSIS (APD)201.3.202AUTOMATED PERITONEAL DIALYSIS (APD)a method to perform dialysis with automated fluid exchanges in the peritoneum201.3.203DIALYSING SOLUTIONapharmaceuticalpreparation (solution), according tothe relevant

33、 pharmacopoeia monograph,for use with PD EQUIPMENT201.3.204DIALYSING SOLUTION CIRCUITpart of the fluid circuit that conveys DIALYSING SOLUTION from the PD EQUIPMENT to the peritoneal cavity of the PATIENT ,and subsequently to a drainage bag or drain,or partspermanently and conductively connected to

34、the flu id circuit NOTE This is an APPLIED PART. 201.3.205INFLOWphase during which the peritoneal cavity is filledNOTE The term “fill” is commonly used as a synonym for “inflow”. 201.3.206OUTFLOWphase during which the peritoneal cavity is emptiedNOTE The term “drain” is commonly used as a synonym fo

35、r “outflow”.201.3.207PERITONEAL DIALYSISprocess wherebya DIALYSING SOLUTION is introduced into the peritoneal cavity ofthe PATIENTand is subsequentlyremoved201.3.208PERITONEAL DIALYSIS ME EQUIPMENT ( PD EQUIPMENT ) ME EQUIPMENT used to perform PERITONEAL DIALYSIS including APD ME EQUIPMENTBS EN 6060

36、1-2-39:2008+A11:2011 EN 60601-2-39:2008+A11:2011 (E) 9 201.3.209PROTECTIVE SYSTEMautomatic system, or a constructional feature, specifically designed to protect the PATIENTagainst HAZARDS which can arise 201.4 GeneralrequirementsClause 4 ofthe generalstandard applies, except asfollows:201.4.3 E SSEN

37、TIAL PERFORMANCEAdditional subclause:201.4.3.101 Additional ESSENTIAL PERFORMANCE requirementsAdditional ESSENTIAL PERFORMANCE requirements: DIALYSING SOLUTION flow to the patient; DIALYSING SOLUTION flow from the patient; temperature of dialysate; adherence to and accuracy of the volume balancing(i

38、 nflow/outflow volume).201.4.7 S INGLE FAULTCONDITION for ME EQUIPMENTAdditional subclause:201.4.7.101 NORMAL CONDITION and SINGLE FAULTCONDITION for PD EQUIPMENTFailure of any PROTECTIVE SYSTEM.Example of SINGLE FAULT CONDITION : failure of a PROTECTIVE SYSTEM (see 201.12.4.101, 201.12.4.103,201.12

39、.4.104)201.5General requirements for testing of PD EQUIPMENTClause 5 ofthe generalstandard applies, except asfollows:201.5.4Other conditions Addition:aa) When the outcome ofa testcan be affected by the initial temperature of the DIALYSINGSOLUTION , the temperature of the DIALYSING SOLUTION at the st

40、art of the test shall be lessthan 4C or the minimum temperature specified by the manufacturer. bb) If temperatures of storage and transport conditions caninfluence normal use shortly aftertransport, this shall be addressed by the RISK MANAGEMENT PROCESS. 201.6 Classification of ME EQUIPMENT and ME S

41、YSTEMSClause 6 ofthe generalstandard applies . 201.7 P DEQUIPMENT identification, marking and documents Clause 7 ofthe generalstandard applies, except asfollows:BS EN 60601-2-39:2008+A11:2011 EN 60601-2-39:2008+A11:2011 (E) 10 201.7.9 A CCOMPANYING DOCUMENTS201.7.9.1 GeneralAddition:The ACCOMPANYING

42、 DOCUMENTS shall additionally includea statement that protective measures should be taken to prevent back syphonage of the outflow path. Example: A statement pointing out the importance of a n air gapbetween theDIALYSING SOLUTION circuit and the drain in order to prevent back syphonage of theOUTFLOW

43、 path.NOTESince the drainage of the fluid is normally connected by the patient it is the responsibility of themanufacturer to warn the patient of the need for backsyphonage protection and the patients responsibility toensure that it is done correctly.201.7.9.2 Instructions for use Additional subclau

44、se:201.7.9.2.101Theinstructions for use shall additionallyinclude the following:a) a description of the method(s) by which anynecessary disinfectionor sterilizationisachieved;b) a statement thatthe test procedure bywhich theeffectiveness of any sterilizationordisinfection has been verified is availa

45、ble on request;c) a statement which draws the OPERATOR s attention to the HAZARDS associated with theconnection and disconnection of the PATIENT ; d) an explanation of the OPERATOR s actions required to respond to alarm(s) from anyPROTECTIVE SYSTEM; e) a list ofrecommended DIALYSING SOLUTION circuit

46、s for use with the PD EQUIPMENT; f) a statement on the possible HAZARDS associated with electromagneticradiation which can affect the safe operationof the ME EQUIPMENT . This statement should include examples oftypical ME EQUIPMENT which can generate such radiation and also take account of potential

47、conditions in domesticenvironments; g) a statementof theimportanceof the qualityof the protective earth in the installationwhen CLASS I ME EQUIPMENT is used;h) a statement of the applications in which a POTENTIAL EQUALIZATION CONDUCTOR should be used;i) a statement that draws the OPERATOR s attentio

48、n to potential HAZARDS arising fromimproper installation and connection of the DIALYSING FLUID circuit;j) a statement that draws the OPERATOR s attention to potential HAZARDS relating to inappropriate selection of the DIALYSING SOLUTION . k) descriptions about the behaviours of PD EQUIPMENT out of t

49、he NORMAL USEcondition definedin its specification.Compliance is checked by inspection.201.7.9.3 Technical descriptionAdditional subclause:BS EN 60601-2-39:2008+A11:2011 EN 60601-2-39:2008+A11:2011 (E) 11 201.7.9.3.101 The technical description shalladditionally include the following:a) the particular measu res or conditions to be obse rved when installing the PD EQUIPMENT orbringing it into use, including guidance on the typeand number ofte sts to be carried out;b) the type and acc