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1、FORSLAG DRAFT DSF/FprEN 80601-2-35:2008 Forslagsnr.:M231977 Draft no.: Forslaget bygger p:FprEN 80601-2-35:2008IDT The draft is based on: IEC 80601-2-35 Ed. 2.0 - 62D/690/CDVIDT (IDT = identisk med/identical to - EQV = baseret p/equivanent to - MOD = modificeret/modified) Dette forslag til Dansk Sta
2、ndard er/har vret p offentlig hring fra: This draft Danish Standard is/was submitted for public enquiry from: 2008-07-15til/to2008-09-15 Forslag til Dansk titel: Elektromedicinsk udstyr - Del 2-35: Srlige krav til basis sikkerhed og grundlggende ydeevne af tpper, underlag og madresser der benyttes s
3、om varmende underlang i medicinsk behandling Proposal for English title: Medical electrical equipment - Part 2-35: Particular requirements for basic safety and essential performance of blankets, pads and mattresses, intended for heating in medical use Kommentarer skal vre DS i hnde senest:2008-09-15
4、 Comments shall be sent to DS no later than: Der kan kun fremsendes kommentarer, sfremt forslaget er i hring som ISO/DIS, IEC/CDV eller som prEN p enquiry i CEN og CENELEC. Tekniske kommentarer behandles ikke, hvis forslaget er til afstemning som ISO/FDIS, IEC/FDIS, CEN eller CENELEC Formal Vote. Co
5、mments can only be submitted if the draft is subject to ISO/DIS, IEC/CDV or CEN/CENELEC Enquiry as a prEN Technical comments will not be taken into account if the draft is subject to ISO/FDIS, IEC/FDIS - CEN/CENELEC Formal Vote. Kommentarer fremsttes ved at rekvirere en elektronisk kommentarskabelon
6、 hos projektlederen. Skabelonen udfyldes og returneres til projektlederen inden hringsperiodens udlb. Modtagne kommentarer vil blive behandlet af det teknisk ansvarlige udvalg. A template for comments must be used and can be obtained from the responsible project manager. The comments will be dealt w
7、ith in the DS Committee responsible for the area. Standardiseringsudvalg:DS/S-562 DS committee: Projektleder:Regnar Schultz Project manager: rsds.dk Bemrk, at forslaget skal bearbejdes yderligere, og at det derfor ikke har gyldighed som Dansk Standard. Note that the draft will be edited further and
8、has no validation as a Danish Standard. Copyright Dansk Standard Provided by IHS under license with DS-DANSKLicensee=Boeing Co/5910770001 Not for Resale, 09/23/2008 01:04:49 MDTNo reproduction or networking permitted without license from IHS -,-,- 21913 Dear Member, The following document is being c
9、irculated for vote at CENELEC level : Project FprEN 80601-2-35:2008CLC reference IEC 80601-2-35:200X (62D/690/CDV) (EQV)Reference document : : : Medical electrical equipment - Part 2-35: Particular requirements for basic safety and essential performance of blankets, pads and mattresses, intended for
10、 heating in medical use Title: CLC/TC 62CLC/TC: IEC/SC 62DIEC/TC: parallel vote on CDVProcedure: 2008-06-13Submission date: 2008-11-14Deadline: dor + 3 monthsdoa: dor + 9 monthsdop: dor + 36 monthsdow: MDD (93/42/EEC)Directive(s): -Mandate(s): EN 60601-2-35:1996Supersedes: -Available languages: Docu
11、ment link:- Mr Nick BRADFIELD(Acting) Secretary: -Assistant Secretary: Dr Peter LINDERSChairman / Convenor: -Note: CS general remarks : - The National Committees are invited to check carefully the validity of the proposed implementation dates and Directive(s). - If the above project is submitted sim
12、ultaneously to the IEC voting procedure in the framework of the IEC/CENELEC co-operation agreement (parallel procedure) you will receive the text of the document from the IEC Central Office. In case your vote would be different in IEC and CENELEC, a detailed technical justification should be sent to
13、 the CENELEC Central Secretariat, with copy to the IEC Central Office. - Superseded HDs or ENs are withdrawn at the dow of the new standard. Yours sincerely, Procedures Unit procedurescenelec.eu CENELEC Central Secretariat 35 rue de Stassart B-1050 Brussels Belgium - The above notes do not apply in
14、the case of a withdrawal vote. -BT decision: Dr MELLISHc.c.: Copyright Dansk Standard Provided by IHS under license with DS-DANSKLicensee=Boeing Co/5910770001 Not for Resale, 09/23/2008 01:04:49 MDTNo reproduction or networking permitted without license from IHS -,-,- FORM CDV (IEC) 2005-09-23 62D/6
15、90/CDV COMMITTEE DRAFT FOR VOTE (CDV) PROJET DE COMIT POUR VOTE (CDV) Project number IEC 62D/80601-2-35/Ed.2 Numro de projet IEC/TC or SC: 62D CEI/CE ou SC: Secretariat / Secrtariat AAMI (for USNC) Submitted for parallel voting in CENELEC Soumis au vote parallle au CENELEC Date of circulation Date d
16、e diffusion 2008-06-13 Closing date for voting (Voting mandatory for P-members) Date de clture du vote (Vote obligatoire pour les membres (P) 2008-11-14 Also of interest to the following committees Intresse galement les comits suivants Supersedes document Remplace le document 62D/604/CD any IEC Nati
17、onal Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (I
18、SO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation
19、from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be
20、 held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. An
21、y divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with an IEC Public
22、ation. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, prope
23、rty damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative References cited in t
24、his publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any
25、or all such patent rights. International Standard IEC 80601-2-35 has been prepared by IEC subcommittee 62D Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This edition cancels and replaces the first edition of IEC 60601-2-35. This edition constitute
26、s a technical revision. The main purpose of this new edition, however, is to provide consistency with the Third Edition of the general standard. This edition further provides consistency with the four other particular standards related to paediatric equipment for which the Committee is responsible.
27、The text of this particular standard is based on the following documents: IEC 60601-2-35:1996, Particular requirements for basic safety and essential performance of blankets, pads and mattresses intended for heating in medical use. Text of this particular standard relating to forced air warmers is b
28、ased on the following document: ASTM F2196-02, Standard specification for circulating liquid and forced air patient temperature management devices. Copyright Dansk Standard Provided by IHS under license with DS-DANSKLicensee=Boeing Co/5910770001 Not for Resale, 09/23/2008 01:04:49 MDTNo reproduction
29、 or networking permitted without license from IHS -,-,- 80601-2-35 Ed.2/CDV IEC:2008 5 Full information on the voting for the approval of this collateral standard can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Direc
30、tives, Part 2. 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 of tables is also in a smaller ty
31、pe. TERMS 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, inclusive of all subdivisions (e.g. Clause 7 i
32、ncludes 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 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 collater
33、al standard are by number only. In 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
34、 this standard, the auxiliary verb: “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
35、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 that there is guidance or rationale related to that item in Annex AA. The committee has decided that the contents of this
36、collateral standard will remain unchanged until the maintenance result date1) indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed; withdrawn; replaced by a revised edition, or amended. 1) The N
37、ational Committees are requested to note that for this publication the maintenance result date is 2012. Copyright Dansk Standard Provided by IHS under license with DS-DANSKLicensee=Boeing Co/5910770001 Not for Resale, 09/23/2008 01:04:49 MDTNo reproduction or networking permitted without license fro
38、m IHS -,-,- 80601-2-35 Ed.2/CDV IEC:2008 6 INTRODUCTION The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of BLANKETS, PADS and MATTRESSES intended for heating in medical use. This particular standard ame
39、nds and supplements IEC 60601-1 (third edition, 2005) Medical electrical equipment Part 1: General requirements for safety and essential performance, hereinafter referred to as the general standard. The requirements are followed by specifications for the relevant tests. Following the decision taken
40、by subcommittee 62D at the meeting in Washington in 1979, a “General guidance and rationale“ section giving some explanatory notes, where appropriate, about the more important requirements is included in Annex AA. While K (degree Kelvin) is the recognized unit and symbol for absolute temperature and
41、 temperature difference, C has been used throughout this particular standard because all measurements are commonly be made using equipment marked with the Celsius temperature scale. Clauses or subclauses for which there are explanatory notes in Annex AA are marked with an asterisk (*). Copyright Dan
42、sk Standard Provided by IHS under license with DS-DANSKLicensee=Boeing Co/5910770001 Not for Resale, 09/23/2008 01:04:49 MDTNo reproduction or networking permitted without license from IHS -,-,- 80601-2-35 Ed.2/CDV IEC:2008 7 MEDICAL ELECTRICAL EQUIPMENT Part 2-35: Particular requirements for basic
43、safety and essential performance of blankets, pads and mattresses intended for heating in medical use 201.1 Scope, object and related standards Clause 1 of the general standard applies, except as follows: 201.1.1 * Scope Subclause 1.1 of the general standard is replaced by: This International Standa
44、rd applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of BLANKETS, PADS and MATTRESSES intended for heating in medical use, also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of th
45、at clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. If a clause or subclause is specifically intended to apply to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then th
46、e clause or subclause is entitled as such. Clauses or subclauses that apply to all types of ME EQUIPMENT within the scope of this standard are not specifically entitled. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not co
47、vered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This particular standard specifies safety requirements for BLANKETS, PADS and MATTRESSES, as defined in 201.3.201 201.3.216 and 201.3.213, respectively, of t
48、his standard, but alternate methods of compliance with a specific clause or subclause by demonstrating equivalent safety will not be judged non-compliant if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE (see ISO 14971) that the RISKS presented by the HAZARDS are of an acceptable level when weighed against the benefits of treatment using the device Additional subclause: 201.1.1.101 * Equipment excluded This particular standard does not apply to: HEATING DEVICES intended for physiotherapy; radiant warmers; for information, see IEC 60601-2-21; incubators;