EN 60601-2-50-2009 en Medical electrical equipment - Part 2-50 Particular requirements for the basic safety and essential performance of infant phototherapy equipment (Incorporates.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 tP a r t 2 - 5 0 : 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 y a 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 p h o t o t h e r a p y e q u i p m e n tB S E N 6 0 6 0 1 - 2 - 5 0 : 2 0 0 9 + A 1 1 : 2 0 1 1National forewordThis British Standard is the UK implementation of It supersedes BS EN 60601-2-50:2009, 1 October 2014.The UK participation in its preparation was entrusted

3、by Technical Committee CH/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

4、a contract. Users are responsible for its correct application. The British Standards Institution 2012. Published by BSI Standards Limited 2012ISBN 978 0 580 77238 2 ICS 11.040.60Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under

5、 the authority of the Standards Policy and Strategy Committee on 31 July 2009.A m e n d m e n t 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 affectedBRITISH STANDARDB S E N 6 0 6 0 1 - 2 - 5 0 : 2 0 0 9 + A 1 1 : 2 0 1 1EN 60601-2-50:2009+A11:2011. It is identical to

6、IEC 60601-2-50:2009. which will be withdrawn on Implementation of CENELEC amendment A11:2011: Annex ZZ replaced31 March 2012EUROPEAN STANDARD EN 60601-2-50:2009+A11NORME EUROPENNE EUROPISCHE NORMCENELEC European Committee forElectrotechnicalStandardization Comit Europen de Normalisation Electrotechn

7、iqueEuropisches Komitee fr Elektrotechnische NormungCentral 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 60601-2-50:2009 EICS 11.040.60 Supersedes BS EN 60601-2-50:2009English

8、versionMedical electricalequipment - Part 2-50: Particular requirementsfor the basic safetyand essential performanceof infant phototherapy equipment(IEC 60601-2-50:2009)A ppareils lectromdicaux -Partie 2-50: Exigences particulires pour la scurit de base et les performances essentielles des appareils

9、 de photothrapie pour nouveau-ns(CEI 60601-2-50:2009)Medizinische elektrische Gerte -Teil 2-50: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Suglings-Phototherapiegerten(IEC 60601-2-50:2009)This European Standard was approved by CENELEC on 2009-05-01.

10、 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 concerning such national standards may be obtained

11、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 into its own language and notifiedto the Central Secr

12、etariat 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, Italy, Latvia,Lithuania, Luxembourg, Malta, the N

13、etherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.October 2011Foreword The text of document 62D/736A/FDIS, future edition 2 of IEC 60601-2-50, prepared by SC 62D,Electromedical equipment, of IEC TC 62, Electrical equipment in medical

14、 practice, was submitted to theIEC-CENELEC parallel vote and was approved by CENELEC asEN 60601-2-50 on 2009-05-01.This European Standard supersedes EN 60601-2-50:2002.Specific technical changes from EN 60601-2-50:2002 include: requiring graphical representation of the spectral irradiancein the inst

15、ructions for use (this waspreviously optional; see 201.7.9.2.5 b); requirements for support and mounting brackets for ACCESSORIES (see 201.9.8.101); requiring restoration of any preset values upon interruption and restoration of the power supply, ifapplicable (see 201.11.8);and corrections to the fi

16、rst four exposure limits (ELs) listed in Table AA.1.Minor changes from EN 60601-2-50:2002 include replacing the figure containing the eye protectionsymbol with a reference to this same symbol in IEC 60878 (see 201.7.2.101), defining an INFANT (see 201.3.202) and clarifying the titles for subclauses

17、201.5.4.102 and 201.5.4.103.The main purpose, however, is to provide consistency with the general standard EN 60601-1:2006. T hisEN 60601-2-50:2009 further provides consistencywith the four other particular standards related topediatric equipment for which the committee is responsible.The following

18、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) 2010-02-01 latest date by which the national standards conflictingwith the EN have to be withdrawn (dow) 2012-05-01This European Standardhas b

19、een 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 ZZ.In this standard, the following print types are used: Requirements and definitions: roman type. Test specifi

20、cations: 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 DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS.In referring

21、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.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subcl

22、auses ofClause 7). 2 BS EN 60601-2-50:2009+A11:2011 EN 60601-2-50:2009+A11:2011 (E)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 number only.In this standard, the conjunctive

23、“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 auxiliary verb: “shall” means that compliance wit

24、h 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 requirement or test. An a

25、sterisk(*) 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.Annexes ZA and ZZ have been added by CENELEC._Endorsement noticeThe textofthe International Standard IEC 60601-2-50:2009 was ap

26、proved by CE NELEC asa European Standard without any modification.In the official version, for Bibliography, the following notes have to be added for the standards indicated:IEC 60335-2-27 NOTE Harmonized as EN 60335-2-27:1997 (not modified).IEC 60601-2-19 NOTE Harmonized as EN 60601-2-19:2009 (not

27、modified).IEC 60601-2-21 NOTE Harmonized as EN 60601-2-21:2009 (not modified).ISO 3743-1 NOTE Harmonized as EN ISO 3743-1:1995 (not modified)._Foreword to amendment A11 This document (EN 60601-2-50:2009/A11:2011) has been prepared by CLC/TC 62 “Electrical equipment in medical practice”. The followin

28、g 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) 2014-10-01 Attention

29、 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. 3 BS EN 60601-2-50:2009+A11:2011 EN 60601-2-50:2009+A11:2011 (E)A nnex ZA(normative)Normative r

30、eferences to international publicationswith their corresponding European publicationsThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies . For undated references, the latest edition of the r eferenceddocument

31、 (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, except as follows: Publication Year Title EN/HD YearReplace the reference to IEC 60601-1-2 by:IEC 6

32、0601-1-2(mod)2007 Medical electrical equipment -Part 1-2: General requirements for basicsafety and essential performance - Collateral Standard: Electromagnetic compatibility -Requirements and testsEN 60601-1-22007 4 BS EN 60601-2-50:2009+A11:2011 EN 60601-2-50:2009+A11:2011 (E)Annex ZZ (informative)

33、 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 essential requirements as given in Annex I of the EC

34、 Directive 93/42/EEC except as follows: Essential Requirement 6a Essential Requirement 7.1 Essential Requirement 7.4 Essential Requirement 7.5 paragraph 2 INFANT INCUBATORS; for information see IEC 60601-2-19; INFANT TRANSPORT INCUBATORS; forinformation, see IEC 60601-2-20; INFANT RADIANTWARMERS;for

35、 information see IEC 60601-2-21. 201.1.2 ObjectReplacement:The object of this particular standard is to establishparticular BASIC SAFETY and ESSENTIALPERFORMANCE requirements for INFANT PHOTOTHERAPY EQUIPMENT (as defined in201.3.203), which reduce the safety HAZARDS to PATIENTS and OPERATORS as much

36、 as possible and tospecify tests for demonstrating compliance with theserequirements. 1) The general standard is IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements forbasic safety and essential performance. 8 BS EN 60601-2-50:2009+A11:2011 EN 60601-2-50:2009+A11:2011 (E)201.

37、1.3 Collateralstandard sAddition:This particular standard refers to those applicable collateral standards that are listed in Clause 2 ofthe generalstandard and Clause 2 of this particularstandard. IEC60601-1-2 applies as modified in Clause 202. IEC 60601-1-3 and IEC60601-1-102) do not apply. All oth

38、er published collateral standardsin the IEC 60601-1 series apply aspublished.201.1.4 Particular standar dsReplacement:In the IEC60601 series, particular standards may modify, replace or delete requirementscontained in the general standard and collateral standards asappropriate for the particularME E

39、QUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIALPERFORMANCE requirements.Arequirement of a particularstandard takes priority overthe general standard.For brevity, IEC60601-1 is referred to in this particular standard as the general standard. Collateral standardsare referred

40、 to bytheir document n umber. Thenumbering of clauses and subclauses of this particular standard corresponds to thatofthegeneral standardwiththe prefix “201” (e.g. 201.1 in this standard addresses the contentof Clause1of the general standard)orapplicable collateral standard with the prefix “20x”wher

41、e x is the final digit(s) of the collateral standard document number (e.g. 202.4 in thisparticular standard addresses the content of Clause4 of the IEC 60601-1-2 collateralstandard, 203.4 in this particular standard addresses the contentof Clause 4 of the IEC60601-1-3 collateral standard, etc.). The

42、 changes to the textof the general standard are specified by the useof the following words:“Replacement“ means that the clause or subclause of the ge neral standard or applicable collateral standard isreplacedcompletely by the text of this particularstandard.“Addition“ means that the text of this pa

43、rticular standard is additional to the requirements ofthegeneral standard or applicable collateral standard.“Amendment“ means that the clause or subclause of the general standard or applicablecollateralstandard is amended as indicated by the text ofthis particular standard.Subclauses, figures or tab

44、les 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, additional definitions in this standard arenumbered beginning from 201.3.201. Additionalannexes are lettered A

45、A, 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 collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc. 2) IEC 60601-1-10:2007, Medical electr

46、ical equipment Part 1-10: General requirements for basic safety and essential performance Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers 9 BS EN 60601-2-50:2009+A11:2011 EN 60601-2-50:2009+A11:2011 (E)The term “this standard“ is used to make referencetoth

47、e general standard, anyapplicablecollateral standards and this particular standard taken together. Where there is no corresponding clause or subclause in this particular standard, the clauseorsubclause ofthe generalstandard or applicable collateral standard, although possibly no t relevant, applies

48、without modification; where it is intended that any partof the generalstandardor applicable collateral standard, although possibly relevant, is nottobe applied, a statement to that effect is given in this particular standard.201.2 NormativereferencesNOTE Informative references are listed in the bibl

49、iography beginning on page 26.Clause 2 ofthe generalstandard applies, except asfollows:Amendment:IEC 60601-1-2:2007, Medical electrical equipment Part 1-2:General requirements forbasic safety and essential performance Collateral standard: ElectromagneticcompatibilityRequirements and tests 201.3Terms and definitionsForthe purposes of this document, the terms and definitions given in IEC 60601-1:2005,apply, except asfollows:NOTE An index of defined terms is found begin