EN 80601-2-35-2009 en Medical electrical equipment - Part 2-35 Particular requirements for the basic safety and essential performance of heating devices using blankets pads and mat.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipmentPart 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended

2、for heating in medical useBS EN 80601-2-35:2009+ A 1 1 : 2 0 1 1BS EN 80601-2-35:2009+A11:2011National forewordThis British Standard is the UK implementation of EN 80601-2-35:2009+A11:2011. It is derived from IEC 80601-2-35:2009. It supersedes BS EN 80601-2-35:2009, which will be withdrawn on 1 Octo

3、ber 2014.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/4, Electromedical equipment.A list of organizations represented on this committee can be obtained on request to its secretary.This publication

4、does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012 Published by BSI Standards Limited 2012ISBN 978 0 580 77241 2 ICS 11.140 Compliance with a British Standard cannot confer immunity from le

5、gal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2010.Amendments/corrigenda issued since publicationDate Text affected29 February 2012 Implementation of CENELEC amendment A11:2011: Annex ZZ updatedBRITISH STANDARDEUROP

6、EAN STANDARD EN 80601-2-35:2009+A11NORME EUROPENNE EUROPISCHE NORM 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 -

7、All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 80601-2-35:2009 E ICS 11.140 English version Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets,

8、 pads and mattresses and intended for heating in medical use (IEC 80601-2-35:2009) Appareils lectromdicaux - Partie 2-35: Exigences particulires pour la scurit de base et les performances essentielles des dispositifs de rchauffage utilisant des couvertures, des coussins ou des matelas chauffants et

9、destins au rchauffage des patients en usage mdical (CEI 80601-2-35:2009) Medizinische elektrische Gerte - Teil 2-35: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Decken, Matten und Matratzen zur Erwrmung von Patienten in der medizinischen Anwendung (I

10、EC 80601-2-35:2009) This European Standard was approved by CENELEC on 2009-11-01. 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 any alteration. Up-to-date lists

11、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 made by translation under the resp

12、onsibility 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, Estonia, Finland, France, German

13、y, 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 2011Supersedes EN 80601-2-35:2009Foreword The text of document 62D/784A/FDIS, future e

14、dition 2 of IEC 80601-2-35, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, and SC 1, Breathing attachments and anaesthetic machines, of ISO TC 121: Anaesthetic and respiratory equipment, was submitted to the IEC-CENELEC parallel vote and was app

15、roved by CENELEC as EN 80601-2-35 on 2009-11-01. This European Standard supersedes EN 60601-2-35:1996. This new edition provides consistency with EN 60601-1:2006, as well as with the four other particular standards related to paediatric equipment for which the committee is responsible. The following

16、 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) 2010-08-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2012-11-01 This European Standard

17、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, the following print types are used: Requirements and definitions: roman type. Test

18、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 THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In r

19、eferring 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.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 ar

20、e 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 this standard, the conjunctive “or” is used as an “inclusive or” so a statement i

21、s 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” means that compliance with a requirement or a test is mandatory for comp

22、liance 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 compliance with a requirement or test. BS EN 80601-2-35:2009+A11:2011 EN 80601-2-35:200

23、9+A11:2011 (E) 2 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. Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standa

24、rd IEC 80601-2-35:2009 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: 10 IEC 60601-2-19 NOTE Harmonized as EN 60601-2-19:2009 (not modified). 11 IEC 60601-2-20 NOTE

25、Harmonized as EN 60601-2-20:2009 (not modified). 12 IEC 60601-2-21 NOTE Harmonized as EN 60601-2-21:2009 (not modified). 19 IEC 60335-2-53 NOTE Harmonized as EN 60335-2-53:2003 (not modified). _ Foreword to amendment A11This document (EN 80601-2-35:2009/A11:2011) has been prepared by CLC/TC 62 “Elec

26、trical 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 the national standards conflicting with this docum

27、ent 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 rights. BS EN 80601-2-35:2009+A11:2011 EN 80601-2-35

28、:2009+A11:2011 (E) 3 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated ref

29、erences, the latest edition of the referenced document (including any amendments) applies. NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Publication Year Title EN/HD Year Amendment: IEC 60601-1-2 (mod) 2007 Medical e

30、lectrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 2007 IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and essent

31、ial performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems EN 60601-1-8 2007 ISO 14971 2007 Medical devices - Application of risk management to medical devices EN ISO 14971 2007 Addition: IEC 60601-

32、1-10 2007 Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers EN 60601-1-10 2008 ISO 2439 2008 Flexible cellular polymeric materials - Determination of

33、 hardness (indentation technique) EN ISO 2439 2008 ISO 3743-1 1994 Acoustics - Determination of sound power levels of noise sources - Engineering methods for small, movable sources in reverberant fields - Part 1: Comparison method for hard-walled test rooms EN ISO 3743-1 2009 BS EN 80601-2-35:2009+A

34、11:2011 EN 80601-2-35:2009+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 and within its scope the standard covers a

35、ll 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 radiant warmers; for information, see IEC 60601-2-21 122; incubators; for informat

36、ion, see IEC 60601-2-19 10; transport incubators, for information, see IEC 60601-2-20 11; cooling devices. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements, which minimize HAZARDS to PATIENTS, and OPERAT

37、ORS for heating 1)The general standard is IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance. 2)Figures in square brackets refer to the Bibliography. BS EN 80601-2-35:2009+A11:2011 EN 80601-2-35:2009+A11:2011 (E) 9 devices using BLA

38、NKETS, PADS or MATTRESSES and intended for heating in medical use and to specify tests for demonstrating compliance with these requirements. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general stan

39、dard and Clause 201.2 of this particular standard. IEC 60601-1-2, IEC 60601-1-8 and IEC 60601-1-10 apply as modified in Articles 202, 208 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 stan

40、dards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete 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 requirem

41、ents. A requirement of a particular standard takes priority over the general standard. For 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 particula

42、r standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in 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.

43、202.4 in this particular standard addresses the content of Clause 4 of the 60601-1-2 collateral 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 f

44、ollowing words: “Replacement“ means that the clause or subclause of the general standard or 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 stand

45、ard or applicable collateral standard. “Amendment“ means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard. Subclauses or figures which are additional to those of the general standard are numbered st

46、arting from 201.101. However due to the fact that definitions in the general standard 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

47、 which are additional to those of a collateral standard are numbered starting 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. The term “this standard“ is used to make reference to the general standard, any applicable collateral st

48、andards and this particular standard taken together. BS EN 80601-2-35:2009+A11:2011 EN 80601-2-35:2009+A11:2011 (E) 10 Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly

49、 not relevant, applies without modification; where it is intended that any part of 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 NOTE Informative references are listed in the Bibliography. Clause 2 of the general standard applies, except as follows: Amendment: IEC 60601-1-2:2007, Medical electrical equipment Part 1-