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1、a Date: 30 October 2008 Origin: International Latest date for receipt of comments: 28 December 2008Project no.: 2008/03460 Responsible committee: CH/121/5 Lung ventilators, tracheal tubes and related equipment Interested committees: Title: Draft BS ENISO 23328-2 Breathing system filters for anaesthe
2、tic and respiratory use Part 2: Non-filtration aspects (ISO 23328-2:2002) Supersession information: If this document is published as a standard, the UK implementation of it will supersede NONE and partially supersede. NONE If you are aware of a current national standard which may be affected, please
3、 notify the secretary (contact details below). WARNING: THIS IS A DRAFT AND MUST NOT BE REGARDED OR USED AS A BRITISH STANDARD. THIS DRAFT IS NOT CURRENT BEYOND 31 January 2009. This draft is issued to allow comments from interested parties; all comments will be given consideration prior to publicat
4、ion. No acknowledgement will normally be sent. See overleaf for information on commenting. No copying is allowed, in any form, without prior written permission from BSI except as permitted under the Copyright, Designs and Patent Act 1988 or for circulation within a nominating organization for briefi
5、ng purposes. Electronic circulation is limited to dissemination by e-mail within such an organization by committee members. Further copies of this draft may be purchased from BSI Customer Services, Tel: +44(0) 20 8996 9001 or email . British, International and foreign standards are also available fr
6、om BSI Customer Services. Information on the co-operating organizations represented on the committees referenced above may be obtained from the responsible committee secretary. Cross-references The British Standards which implement International or European publications referred to in this draft may
7、 be found via the British Standards Online Service on the BSI web site http:/. Direct tel: 020 8996 7628 Responsible Committee Secretary: Ms Margaret Dempsey (BSI) E-mail: Draft for Public Comment Head Office 389 Chiswick High Road London W4 4AL Telephone: +44(0)20 8996 9000 Fax: +44(0)20 8996 7001
8、 Form 36 Version 8.0 DPC: 08/30191694 DC Licensed Copy: London South Bank University, South Bank University, 31/01/2009 04:14, Uncontrolled Copy, (c) BSI b Introduction This draft standard is based on international discussions in which the UK has taken an active part. Your comments on this draft are
9、 invited and will assist in the preparation of the consequent standard. Comments submitted will be reviewed by the relevant BSI committee before sending the consensus UK vote and comments to the international secretariat, which will then decide appropriate action on the draft and the comments receiv
10、ed. If the international standard is approved, it is possible the text will be published as an identical British Standard. UK Vote Please indicate whether you consider the UK should submit a negative (with reasons) or positive vote on this draft. Submission The guidance given below is intended to en
11、sure that all comments receive efficient and appropriate attention by the responsible BSI committee. Annotated drafts are not acceptable and will be rejected. All comments must be submitted, preferably electronically, to the Responsible Committee Secretary at the address given on the front cover. Co
12、mments should be compatible with Version 6.0 or Version 97 of Microsoft Word for Windows, if possible; otherwise comments in ASCII text format are acceptable. Any comments not submitted electronically should still adhere to these format requirements. All comments submitted should be presented as giv
13、en in the example below. Further information on submitting comments and how to obtain a blank electronic version of a comment form are available from the BSI web site at: http:/ Template for comments and secretariat observations Date: xx/xx/200x Document: ISO/DIS xxxxx 1 2 (3) 4 5 (6) (7) MB Clause
14、No./ Subclause No./ Annex (e.g. 3.1) Paragraph/ Figure/Table/ Note (e.g. Table 1) Type of com- ment Comment (justification for change) by the MB Proposed change by the MB Secretariat observations on each comment submitted 3.1 Definition 1 ed Definition is ambiguous and needs clarifying. Amend to rea
15、d . so that the mains connector to which no connection . 6.4 Paragraph 2 te The use of the UV photometer as an alternative cannot be supported as serious problems have been encountered in its use in the UK. Delete reference to UV photometer. Microsoft and MS-DOS are registered trademarks, and Window
16、s is a trademark of Microsoft Corporation. Licensed Copy: London South Bank University, South Bank University, 31/01/2009 04:14, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM FINAL DRAFT prEN ISO 23328-2 October 2008 ICS 11.040.10Will supersede EN ISO 23328-2:2008 Engl
17、ish Version Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002) Filtres pour matriel danesthsie et de ranimation respiratoire - Partie 2: Aspects autres que la filtration (ISO 23328-2:2002) Filter fr Atemsysteme zur Anwendung bei Ansthesie
18、 und Beatmung - Teil 2: Aspekte, die nicht die Filtration betreffen (ISO 23328-2:2002) This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee CEN/TC 215. If this draft becomes a European Standard, CEN members are boun
19、d 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. This draft European Standard was established by CEN in three official versions (English, French, German). A version in any
20、other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Esto
21、nia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Warning : This document is not a European Standard. It is distributed for
22、review and comments. It is subject to change without notice and shall not be referred to as a European Standard. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2008 CENAll rights of exploitat
23、ion in any form and by any means reserved worldwide for CEN national Members. Ref. No. prEN ISO 23328-2:2008: E Licensed Copy: London South Bank University, South Bank University, 31/01/2009 04:14, Uncontrolled Copy, (c) BSI prEN ISO 23328-2:2008 (E) 2 Contents Page Foreword3 Annex ZA (informative)
24、Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC4 Licensed Copy: London South Bank University, South Bank University, 31/01/2009 04:14, Uncontrolled Copy, (c) BSI prEN ISO 23328-2:2008 (E) 3 Foreword The text of ISO 23328-2:2002 has been prepared b
25、y Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as prEN ISO 23328-2:2008 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI. Thi
26、s document is currently submitted to the Unique Acceptance Procedure. This document will supersede EN ISO 23328-2:2008. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive
27、. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. Endorsement notice The text of ISO 23328-2:2002 has been approved by CEN as a prEN ISO 23328-2:2008 without any modification. Licensed Copy: London South Bank University, South Bank University
28、, 31/01/2009 04:14, Uncontrolled Copy, (c) BSI prEN ISO 23328-2:2008 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and
29、the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national stand
30、ard in at least one Member State, compliance with the clauses of this standard given in Table ZA. confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA. - Relatio
31、nship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Clause(s)/sub- clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4 1, 2, 3, 4, 7.5, 9.1 5 3, 4, 7.5, 7.6 - 6a This relevant Essential Requirement is not addre
32、ssed in this European Standard 5.3 7.5 (1st paragraph) This relevant Essential Requirement is not fully addressed in this European Standard - 7.5 (2nd paragraph) This relevant Essential Requirement is not addressed in this European Standard - 7.5 (3rd paragraph) This relevant Essential Requirement i
33、s not addressed in this European Standard 6 2, 5, 7.2, 8.1, 8.3, 8.4, 8.5 7 13.1 7.1 13.2 7.2 13.1, 13.2, 13.3j), 13.6c) 7.3 13.3a), b), c), d), e), i), 13.4, 13.5 7.3 13.3 (a): This relevant Essential Requirement is not fully addressed in this European Standard 7.3c) 8.7, 13.3c) 7.4 13.3b), f) Lice
34、nsed Copy: London South Bank University, South Bank University, 31/01/2009 04:14, Uncontrolled Copy, (c) BSI prEN ISO 23328-2:2008 (E) 5 7.4 13.3 (f) This relevant Essential Requirement is not fully addressed in this European Standard 8 13.1, 13.6a), b) 8 13.6 (h)(2nd paragraph) This relevant Essent
35、ial Requirement is not fully addressed in this European Standard - 13.6 (q) This relevant Essential Requirement is not addressed in this European Standard 8a) 13.6d) 8f) 13.6f), m) 8g) 8.7, 13.3m), 13.6d), g), h), i) 8i) 13.6n) 8k) 13.6c) Warning Other requirements and other EU Directives may be applicable to the products falling within the scope of this International standard. Licensed Copy: London South Bank University, South Bank University, 31/01/2009 04:14, Uncontrolled Copy, (c) BSI
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