EN 60601-2-19-2009 en Medical electrical equipment - Part 2-19 Particular requirements for the basic safety and essential performance of infant incubators (Incorporates Amendment A.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationM e d i c a l e l e c t r i c a l e q u i p m e n t P a r t 2 - 1 9 : P a r t i c u l a r r e q u i r e m e n t s f o r t h e b a s i c s a f e t ya n d e s s e n t i a l p e r f

2、 o r m a n c e o f i n f a n t i n c u b a t o r sB S E N 6 0 6 0 1 - 2 - 1 9 : 2 0 0 9 + A 1 1 : 2 0 1 1National forewordBRITISH STANDARDBS EN 60601-2-19:2009+A11:2011This British Standard is the UK implementation of1 October 2014.The UK participation in its preparation was entrusted by Technical C

3、ommitteeCH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/4, Electromedical equipment.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Use

4、rs are responsible for its correct application.ISBN 978 0 580 77307 5 ICS 11.040.10Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2009.A m e n d m e n t

5、 s / c o r r i g e n d a i s s u e d s i n c e p u b l i c a t i o nDate Text affectedIt supersedes BS EN 60601-2-19:2009,EN 60601-2-19:2009+A11:2011. It iswhich will be withdrawn on The British Standards Institution 2012Published by BSI Standards Limited 2012Implementation of CENELEC amendment A11:

6、2011: Annex ZZ replaced31 March 2012identical to IEC 60601-2-19:2009.EUROPEAN STANDARD EN 60601-2-19:2009+A11NORME EUROPENNE EUROPISCHE NORMCENELEC European Committee forElectrotechnicalStandardization Comit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr Elektrotechnische NormungCen

7、tral Secretariat:Avenue Marnix 17, B - 1000 Brussels 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELECmembers.Ref. No. EN 60601-2-19:2009 EICS 11.040.10English versionMedical electrical equipment - Part 2-19: Particular requirementsfor the basic sa

8、fetyand essential performanceof infant incubators(IEC 60601-2-19:2009)A ppareils lectromdicaux -Partie 2-19: Exigences particulires pour la scurit de base et les performances essentielles des incubateurs pour nouveau-ns(CEI 60601-2-19:2009)Medizinische elektrische Gerte -Teil 2-19: Besondere Festleg

9、ungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Suglingsinkubatoren (IEC 60601-2-19:2009)This European Standard was approved by CENELEC on 2009-04-01. CENELEC members are bound to complywith the CEN/CENELEC Internal Regulations which stipulate the conditions for giving t

10、his 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 onapplication to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versio

11、ns (English, French, German). A version in any otherlanguage made by translation under the responsibility of a CENELEC member into its own language and notifiedto the Central Secretariat has the same status as the official versions.CENELEC members are the national electrotechnical committees of Aust

12、ria, Belgium, Bulgaria, Cyprus, theCzech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.Octo

13、ber 2011Supersedes EN 60601-2-19:2009Foreword The text of document 62D/727/FDIS, future edition 2 of IEC 60601-2-19, prepared bySC 62D,Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to theIEC-CENELEC parallel vote and was approved by CENELEC asEN 6060

14、1-2-19 on 2009-04-01.This European Standardsupersedes EN 60601-2-19:1996 + A1:1996.EN 60601-2-19:1996 was revised to structurally align with EN 60601-1:2006.The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identicalnational stan

15、dard or by endorsement (dop) 2010-01-01 latest date by which the national standards conflictingwith the EN have to be withdrawn (dow) 2012-04-01This European Standardhas been prepared under a mandate given to CENELEC by the EuropeanCommission and the European Free Trade Association and covers essent

16、ial requirements of EC Directive MDD (93/42/EEC). See Annex ZZ.In this standard, the following 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. N

17、ormative text oftables is also in a smaller type. T ERMS 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,i

18、nclusive of allsubdivisions (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 ofClause 7).References to clauses within this standard are preceded by the term “Clause” followed by the clausenumber. Refe

19、rences to subclauses within this particular standard are by number only.In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combinationof the conditions is true.The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC D

20、irectives,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 thisstandard; “should” means that compliance with a requirement or a test is recommended but is not mandatory forcompliance with this s

21、tandard; “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 indicates thatthere is guidance or rationale related to that item in Annex AA. 2 BS EN 60601-2:19:2

22、009+A11:2011 EN 60601-2:19:2009+A11:2011 (E)Annexes ZA and ZZ have been added by CENELEC._Endorsement noticeThe textofthe International Standard IEC 60601-2-19:2009 was approved by CENELEC asa European Standard without any modification.In the official version, for Bibliogra phy, the following notes

23、have to be added for the standards indicated:IEC 60601-2-21 NOTE Harmonized as EN 60601-2-21:2009 (not modified).IEC 60601-2-50 NOTE Harmonized as EN 60601-2-50:2009 (not modified).IEC 61672-1 NOTE Harmonized as EN 61672-1:2003 (not modified)._Foreword to amendment A11 This document (EN 60601-2-19:2

24、009/A11:2011) has been prepared by CLC/TC 62 “Electrical equipment in medical practice”. 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

25、the national standards conflicting with this document have to be withdrawn (dow) 2014-10-01 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 ri

26、ghts. 3 BS EN 60601-2:19:2009+A11:2011 EN 60601-2:19:2009+A11:2011 (E)A nnex ZA(normative)Normative references to international publicationswith their corresponding European publicationsThe following referenced documents are indispensable for the application of this document. For dated references, o

27、nly the edition cited applies . For undated references, the latest edition of the r eferenceddocument (including any amendments) applies.NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HDapplies.Annex ZA of EN 60601-1:2006 applies

28、, except as follows: Publication Year Title EN/HD YearReplace the reference to IEC 60601-1-2 by:IEC 60601-1-2(mod)2007 Medical electrical equipment -Part 1-2: General requirements for basicsafety and essential performance - Collateral Standard: Electromagnetic compatibility -Requirements and testsEN

29、 60601-1-22007Addition:IEC 60601-1-10 2007 Medical electrical equipment -Part 1-10: General requirements for basicsafety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllersEN 60601-1-10 2008 4 BS EN 60601-2:19:2009+A11:2011 EN 6060

30、1-2:19:2009+A11:2011 (E)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 and within its scope the standard covers all relevant essent

31、ial requirements as given in Annex I of the EC Directive 93/42/EEC ecept as follows: Essential Requirement 6a Essential Requirement 7.4 Essential Requirement 7.5 paragraph 2 forinformation see IEC 80601-2-35 3 2); INFANT RADIANTWARMERS; forinformation, see IEC 60601-2-21 2; INFANT TRANSPORT INCUBATO

32、RS, forinformation, see IEC 60601-2-20 1; INFANT PHOTOTHERAPY EQUIPMENT ,for information see IEC 60601-2-50 4.201.1.2 ObjectReplacement:The object of this particular standard is to establishparticular BASIC SAFETY and ESSENTIALPERFORMANCE requirements for INFANT INCUBATORS as defined in 201.3.208, w

33、hich minimizeHAZARDS to PATIENT and OPERATOR , and to specify tests bywhich compliancewith the requirements can be verified. 1) The general standard is IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements forbasic safety and essential performance.2) Figures in square brackets

34、refer to the Bibliography. 8 BS EN 60601-2:19:2009+A11:2011 EN 60601-2:19:2009+A11:2011 (E)201.1.3 * Collateral standardsAddition:This particular standard refers to those applicable collateral standards that are listed in Clause 2 ofthe generalstandard and Clause 2 of this particularstandard. IEC606

35、01-1-2 and IEC 60601-1-10 apply as modifiedin Clauses 202 and 210 respectively. IEC60601-1-3 does not a pply. All other published collateral standards in the IEC 60601-1 series apply as published.201.1.4 Particularstandards Replacement:In the IEC60601 series, particular standards may modify, replace

36、 or delete requirementscontained in the general standard and collateral standards asappropriate for the particularME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIALPERFORMANCE requirements.Arequirement of a particularstandard takes priority overthe general standard.For br

37、evity, IEC60601-1 is referred to in this particular standard as the general standard. Collateral standardsare referred to bytheir document number. Thenumbering of clauses and subclauses of this particular standard corresponds to thatofthegeneral standardwiththe prefix “201” (e.g. 201.1 in this stand

38、ard addresses the contentof Clause1of the general standard)orapplicable collateral standard with the prefix “20x”where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in thisparticular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard, 203

39、.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateralstandard, etc.). The changes to the text of the general standard are specified by theuse ofthe following words: “Replacement“ means that the clause or subclause of the general standard or applicable collatera

40、l standard isreplacedcompletely by the text of this particularstandard.“Addition“ means that the text of this particular standard is additional to the requirements ofthegeneral standard or applicable collateral standard.“Amendment“ means that the clause or subclause of the general standard or applic

41、ablecollateralstandard is amended as indicated by the text ofthis particular standard.Subclauses, figures or tables which are additional to those of the general standard arenumbered starting from201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.139

42、, additional definitions in this standard arenumbered beginning from 201.3.201. Additionalannexes are lettered AA, BB, etc., and additional items aa), bb) , etc.Subclauses or figures which areadditional tothose ofa collateral standard are numberedstarting from 20x, where “x”is the number of the coll

43、ateral standard,e.g. 202 forIEC 60601-1-2, 203 forIEC 60601-1-3, etc.The term “this standard“ is used to make referencetothe general standard, anyapplicablecollateral standards and this particular standard taken together. Where there is no corresponding clause or subclause in this particular standar

44、d, the clauseorsubclause ofthe generalstandard or applicable collateral standard, although possibly not 9 BS EN 60601-2:19:2009+A11:2011 EN 60601-2:19:2009+A11:2011 (E)relevant, applies without modification; where it is intended that any partof the generalstandardor applicable collateral standard, a

45、lthough possibly relevant, is nottobe applied, a statement to that effect is given in this particular standard.201.2Normative referencesClause 2 ofthe generalstan dard applies, except asfollows:Amendment:IEC 60601-1-2:2007, Medical electrical equipment Part 1-2:General requirements forbasic safety a

46、nd essential performance Collateral standard: ElectromagneticcompatibilityRequirements and tests Addition:IEC 60601-1-10:2007, Medical electrical equipment Part 1-10: General requirements forbasic safety and essential performance Collateral Standard: Requirements for thedevelopment of physiologicclo

47、sed-loop controllersNOTE Informative references are listed in the bibliography beginning on page 34.201.3Terms and definitionsForthe purposes of this document, the terms and definition s given in IEC 60601-1:2005,apply, except asfollows:NOTE An index of defined terms is found beginning on page35.Add

48、ition:201.3.201AIR CONTROLLED INCUBATORINFANT INCUBATOR in which the airtemperature is automatically controlled by an airtemperature sensor according to the CONTROL TEMPERATURE set by the OPERATOR201.3.202AVERAGE INCUBATOR TEMPERATUREaverage of the INCUBATOR TEMPERATURE readings taken at regularinte

49、rvals achieved duringSTEADY TEMPERATURE CONDITION (see Figure 201.102)201.3.203AVERAGE TEMPERATUREaverage of temperaturereadingstaken at regular intervals at anyspecified point in the COMPARTMENT achieved during STEADY TEMPERATURE CONDITION201.3.204BABY CONTROLLED INCUBATORan AIR CONTROLLED INCUBATOR which has the additional capability ofautomatically controlling the INCUBATOR air temperature in order to maintain the temperatureasmeasured by a SKINTEMPERATURE SENSOR according