EN 60601-2-20-2009 en Medical electrical equipment - Part 2-20 Particular requirements for the basic safety and essential performance of infant transport incubators (Incorporates A.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipment Part 2-20: Particular requirements for the basic safety and essential performance of infant transportincubatorsBS EN 60601-2-20:2009+A11:2011National

2、 forewordThis British Standard is the UK implementation of It supersedes BS EN 60601-2-20:2009,October 2014.The UK participation in its preparation was entrusted by Technical Com-mittee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/4, Electromedical equipment.A list of organ

3、izations 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. Users are responsible for its correct application.ISBN 978 0 580 77236 8ICS 11.040.10Compliance with a British Standard canno

4、t confer immunity fromlegal obligations.This British Standard was published under the authority of the Stan-dards Policy and Strategy Committee on 31 January 2010Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 60601-2-20:2009+A11:2011 The British Standars Instit

5、ution 2012. Published by BSI StandardsLimited 201229 February 2012 Implementation of CENELEC amendment A11October 2011: Annex ZZ replacedEN 60601-2-20:2009+A11:2011. It is derived from IEC 60601-2-20:2009. which will be withdrawn on 1 EUROPEAN STANDARD EN 60601-2-2009:A11NORME EUROPENNE EUROPISCHE N

6、ORM CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: Avenue Marnix 17, B - 1000 Brussels 2009 CENELEC - All rights of exploitation in any form and by any means reserve

7、d worldwide for CENELEC members. Ref. No. EN 60601-2-20:2009 E ICS 11.040.10 Supersedes EN 60601-2-20:1996English version Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (IEC 60601-2-20:2009) Appareils le

8、ctromdicaux - Partie 2-20: Exigences particulires pour la scurit de base et les performances essentielles des incubateurs de transport pour nouveau-ns (CEI 60601-2-20:2009) Medizinische elektrische Gerte - Teil 2-20: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsme

9、rkmale von Tranportinkubatoren (IEC 60601-2-20:2009) This European Standard was approved by CENELEC on 2009-09-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without

10、any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language m

11、ade by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark,

12、 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 document 62D/731/FDIS, futur

13、e edition 2 of IEC 60601-2-20, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-20 on 2009-09-01. This European Standard supersedes EN 60601-2-20:1996. EN 606

14、01-2-20:1996 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 identical national standard or by endorsement (dop) 2010-06-01 latest date by which the national standards con

15、flicting with the EN have to be withdrawn (dow) 2012-09-01 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive MDD (93/42/EEC). See Annex ZZ. In this standard, t

16、he 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 of tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 OF T

17、HE 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 all subdivisions (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 particular standard are by number only. In

19、 this standard, 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

20、: “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way to achieve compl

21、iance 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 that there is guidance or rationale related to that item in Annex AA. 2 BS EN 60601-2-20:2009+A11:2011 EN 60601-2-20:2009+A11:2011 (E)Annexes ZA and ZZ have

22、 been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-2-20:2009 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 80601-2-35

23、 NOTE Harmonized as EN 80601-2-35:2009 (not modified). IEC 60601-2-19 NOTE Harmonized as EN 60601-2-19:2009 (not modified). 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 6167

24、2-1:2003 (not modified). ISO 21647 NOTE Harmonized as EN ISO 21647:2009 (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 following dates are fixed: latest date by which this document

25、 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 is drawn to the possibility that some of the element

26、s 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 60601-2-20:2009+A11:2011 EN 60601-2-20:2009+A11:2011 (E)Annex ZA (normative) Normative references to international publications with their c

27、orresponding European publications The 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 referenced document (including any amendments) applies. NOTE When an i

28、nternational publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year Replace the reference to IEC 60601-1-2 by: IEC 60601-1-2 (mod) 2007 Medical electrical equipme

29、nt - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 2007 Addition: IEC 60601-1-10 2007 Medical electrical equipment - Part 1-10: General requirements for basic safety and essential p

30、erformance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers EN 60601-1-10 2008 ISO 32 -1)Gas cylinders for medical use - Marking for identification of content - - ISO 407 -1)Small medical gas cylinders - Pin-index yoke-type valve connections - - 1)Undate

31、d reference. 4 BS EN 60601-2-20:2009+A11:2011 EN 60601-2-20:2009+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 wit

32、hin 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 for information see IEC 80601-2-35 11); INFANT

33、 INCUBATORS which are not INFANT TRANSPORT INCUBATOR; for information see IEC 60601-2-19 2; INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 3; INFANT PHOTOTHERAPY; for information, see IEC 60601-2-50 4. 201.1.2 Object Replacement: The object of this particular standard is to establish pa

34、rticular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for INFANT TRANSPORT INCUBATORS as defined in 201.3.211, which minimize HAZARDS to the PATIENT and OPERATOR, and to specify tests by which compliance with the requirements can be verified. 1)Figures between square brackets refer to the Bib

35、liography. 8 BS EN 60601-2-20:2009+A11:2011 EN 60601-2-20:2009+A11:2011 (E)201.1.3 *Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 2 of this particular standard. IEC 60601-1-2 and

36、IEC 60601-1-10 apply as modified in Clauses 202 and 210 respectively. IEC 60601-1-3 does not apply. All other published collateral standards in the IEC 60601-1 series apply as published. 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or de

37、lete requirements contained in the general standard and collateral standards as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes priority over the general standard. For

38、 brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 i

39、n this standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the 60601-1-2 colla

40、teral standard, 203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words: “Replacement“ means that the clause or subclause of the general standard o

41、r applicable collateral standard is replaced completely by the text of this particular standard. “Addition“ means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard. “Amendment“ means that the clause or subclause of t

42、he general standard or applicable collateral standard is amended as indicated by the text of this particular standard. Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general stan

43、dard are numbered 3.1 through 3.139, additional definitions in this standard are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Subclauses or figures which are additional to those of a collateral standard are numbered starting fro

44、m 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. The term “this standard“ is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together. Where there is no correspond

45、ing clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly not 9 BS EN 60601-2-20:2009+A11:2011 EN 60601-2-20:2009+A11:2011 (E)relevant, applies without modification; where it is intended that any part of

46、the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard. 201.2 Normative references Clause 2 of the general standard applies, except as follows: NOTE Informative references are listed in

47、 the bibliography beginning on page 38. Amendment: IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests Addition: IEC 60601-1-10:2007, Medical electrical eq

48、uipment Part 1-10: General requirements for basic safety and essential performance Collateral Standard: Requirements for the development of physiologic closed-loop controllers ISO 32, Gas cylinders for medical use Marking for identification of content ISO 407, Small medical gas cylinders Pin-index y

49、oke-type valve connections 201.3 Terms and definitions For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, apply, except as follows: NOTE An index of defined terms is found beginning on page 39. Addition: 201.3.201 AIR CONTROLLED TRANSPORT INCUBATOR INCUBATOR in which the air temperature is automatically controlled by an air temperature sensor close to a value set by the OPERATOR 201.3.202 AVERAGE TEMPERATURE average