EN 60601-2-21-2009 en Medical electrical equipment - Part 2-21 Particular requirements for the basic safety and essential performance of infant radiant warmers (Incorporates Amendm.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipment Part 2-21: Particular requirements for the basic safetyand essential performance of infant radiant warmersBS EN 60601-2-21:2009+A11:2011National fore

2、wordThe UK participation in its preparation was entrusted by Technical CommitteeCH/62, Electrical Equipment in Medical Practice, to SubcommitteeCH/62/4, Electromedical equipment.A list of organizations represented on this subcommittee can be obtained onrequest to its secretary.This publication does

3、not purport to include all the necessary provisions of acontract. Users are responsible for its correct application.ISBN 978 0 580 77237 5ICS 11.040.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of the Standa

4、rdsP o l i c y a n d S t r a t e g y C o m m i t t e e o n 3 1 J u l y 2 0 0 9A m e n d m e n t s / c o r r i g e n d u m i s s u e d s i n c e p u b l i c a t i o nDate Text affectedBRITISH STANDARDBS EN 60601-2-21:2009+A11:2011This British Standard is the UK implementation of It supersedes BS EN 6

5、0601-2-21:2009,October 2014.EN 60601-2-21:2009+A11:2011. It is derived from IEC 60601-2-21:2009. which will be withdrawn on 1 29 February 2012 Implementation of CENELEC amendment A11:2011: The British Standards Institution 2012. Published by BSI StandardsLimited 2012Annex ZZ replacedEUROPEAN STANDAR

6、D EN 60601-2-21:2009+A11NORME EUROPENNE EUROPISCHE NORMCENELEC European Committee forElectrotechnicalStandardization Comit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr Elektrotechnische NormungCentral Secretariat:Avenue Marnix 17, B - 1000 Brussels 2009 CENELEC - All rights of exp

7、loitation in any form and by any means reserved worldwide for CENELECmembers.Ref. No. EN 60601-2-21:2009 EICS 11.040.10 Supersedes EN 60601-2-21:1994 + A1:1996English versionMedical electricalequipment - Part 2-21: Particular requirementsfor the basic safetyand essential performanceof infant radiant

8、 warmers(IEC 60601-2-21:2009)A ppareils lectromdicaux -Partie 2-21: Exigences particulires pour la scurit de base et les performances essentielles des incubateurs radiants pour nouveau-ns (CEI 60601-2-21:2009)Medizinische elektrische Gerte -Teil 2-21: Besondere Festlegungen fr die Sicherheit einschl

9、ielich der wesentlichen Leistungsmerkmale von Suglingswrmestrahlern(IEC 60601-2-21:2009)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 this European Standard the stat

10、us 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 versions (English, French, German).

11、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 Austria, Belgium, Bulgaria, Cyprus

12、, 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.October 2011Foreword The text of d

13、ocument 62D/735/FDIS, future edition 2 of IEC 60601-2-21, 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 60601-2-21 on 2009-04-01.This European Standardsupersedes EN 60

14、601-2-21:1994 + A1:1996.EN 60601-2-21:1994 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 standard or by endorsement (dop) 2010-01-01 latest date by whic

15、h 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 essential requirements of EC Directive MDD (93/42/EEC). See Annex

16、 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. Normative text oftables is also in a smaller type. T ERMS DE

17、FINED 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 allsubdivisions (e.g. Clause 7 includes subclau

18、ses 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. References to subclauses within this particular standard are by

19、 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 Directives,Part 2. For the purposes of this standard, the au

20、xiliary 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 standard; “may”is used to describe a permissible way to achi

21、eve 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 60601-2-21:2009+A11:2011 EN 60601-2-21:2009+A11:2011 (E)Annexes ZA and

22、ZZ have been added by CENELEC._Endorsement noticeThe textofthe International Standard IEC 60601-2-21:2009 was approved by CENELEC asa European Standard without any modification.In the official version, for Bibliogra phy, the following notes have to be added for the standards indicated:IEC 60335-2-27

23、 NOTE Harmonized as EN 60335-2-27:2003 (not modified).IEC 60601-2-19 NOTE Harmonized as EN 60601-2-19:2009 (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).ISO 3743-1 NOTE Harmonized as EN ISO 3743-1:1995

24、 (not modified)._Foreword to amendment A11 This document (EN 60601-2-21:2009/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 n

25、ational standard or by endorsement (dop) 2012-10-01 latest date by which the national standards conflicting with this document have to be withdrawn (dow) 2014-10-01 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CE

26、N shall not be held responsible for identifying any or all such patent rights. 3 BS EN 60601-2-21:2009+A11:2011 EN 60601-2-21:2009+A11:2011 (E)A nnex ZA(normative)Normative references to international publicationswith their corresponding European publicationsThe following referenced documents are in

27、dispensable for the application of this document. For dated references, only 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, indicate

28、d by (mod), the relevant EN/HDapplies.Annex ZA of EN 60601-1:2006 applies, 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 - Col

29、lateral Standard: Electromagnetic compatibility -Requirements and testsEN 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-lo

30、op controllersEN 60601-1-10 2008 4 BS EN 60601-2-21:2009+A11:2011 EN 60601-2-21:2009+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

31、 Association and 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 7.1 Essential Requirement 7.4 Essential Requirement 7.5 paragraph 2 forinformation see IEC 8

32、0601-2-35; INFANT INCUBATORS; for information see IEC 60601-2-19; INFANT TRANSPORT INCUBATORS, forinformation see IEC 60601-2-20; INFANT PHOTOTHERAPY EQUIPMENT ,for information see IEC 60601-2-50.201.1.2 ObjectReplacement:The object of this particular standard is to establishparticular BASIC SAFETY

33、and ESSENTIALPERFORMANCE requirements for INFANT RADIANT WARMERS as defined in 201.3.204, whichminimize HAZARDS to PATIENT and OPERATOR , and to specify tests by which compliance withthe requirements can be verified. 1) The general standard is IEC 60601-1:2005, Medical electrical equipment Part 1: G

34、eneral requirements forbasic safety and essential performance. 8 BS EN 60601-2-21:2009+A11:2011 EN 60601-2-21:2009+A11:2011 (E)201.1.3 *CollateralstandardsAddition:This particular standard refers to those applicable collateral standards that are listed in Clause 2 ofthe generalstandard and Clause 2

35、of this particularstandard. IEC 60601-1-2 and IEC 60601-1-10 apply as modified in Clauses 202 and 210 respectively.IEC60601-1-3 does not apply. All other published collateral standards in the IEC 60601-1 series apply as published.201.1.4 Particular standardsReplacement:In the IEC60601 series, partic

36、ular standards may modify, replace or delete requirementscontained in the general standard and collateral standards as appropriate for the particular MEEQUIPMENT underconsideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCErequirements.Arequirement of a particularstandard takes priori

37、ty overthe general standard.For brevity, IEC60601-1 is referred to in this particular standard as the general standard. Collateral standardsare referred to bytheir document n umber. Thenumbering of clauses and subclauses of this particular standard corresponds to thatofthegeneral standardwiththe pre

38、fix “201” (e.g. 201.1 in this standard 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

39、 60601-1-2 collateral standard, 203.4 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 ge ne

40、ral standard or applicable collateral 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 subclau

41、se of the general standard or applicablecollateralstandard 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 sta

42、ndard are numbered 3.1 through 3.139, additional definitions in this standard arenumbered beginning from 201.3.201. Additionalannexes are lettered AA, BB, etc., and additional items aa), bb) , etc.Subclauses, figures or tables which are additional to those of a collateral standard are numbered start

43、ing from 20x, where “x”is the number of the collateral 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 correspondi

44、ng clause or subclause in this particular standard, the clauseorsubclause ofthe generalstandard or applicable collateral standard, although possibly not 9 BS EN 60601-2-21:2009+A11:2011 EN 60601-2-21:2009+A11:2011 (E)relevant, applies without modification; where it is intended that any partof the ge

45、neralstandardor applicable collateral standard, although possibly relevant, is nottobe applied, a statement to that effect isgiven in this particular standard.201.2 NormativereferencesClause 2 ofthe generalstan dard applies, except asfollows:Amendment:IEC 60601-1-2:2007, Medical electrical equipment

46、 Part 1-2:General requirements forbasic safety and essential performance C ollateral standard: Elect romagneticcompatibility Requirements and tests Addition:IEC 60601-1-10:2007, Medical electrical equipment Part 1-10: General requirements forbasic safety and essential performance Collateral Standard

47、: Requirements for thedevelopment of physiologicclosed-loop controllersNOTE Informative references are listed in the bibliography beginning on page 32.201.3Terms and definitionsForthe purposes of this document, theterms and definitions given in the general standardapply, except asfollows:NOTE An ind

48、ex of defined terms is found beginning on page34.Addition:201.3.201BABY CONTROLLED RADIANTWARMERmode of operation in which the power output varies automatically in order to maintain thetemperature as measured by a SKIN TEMPERATURE SENSOR according to the CONTROL TEMPERATURE set by the OPERATORNOTE A

49、n INFANT RADIANT WARMER operating as a BABY CONTROLLED RADIANT WARMER is a PHYSIOLOGIC CLOSED-LOOP CONTROLLER as defined in IEC 60601-1-10.201.3.202CONTROL TEMPERATUREtemperature selected at the temperature control 201.3.203INFANTPATIENT up to 3 months and with a weight of less than 10 kg201.3.204INFANT RADIANT WARMERelectrically powered device with a radiant heating source intended to maintain the thermalbalance of an INFANT by direct radiation of energy in the infrared region of