09-30197946-DC.pdf
《09-30197946-DC.pdf》由会员分享,可在线阅读,更多相关《09-30197946-DC.pdf(17页珍藏版)》请在三一文库上搜索。
1、a Date: 19 January 2009 Origin: European Latest date for receipt of comments: 2 March 2009 Project no.: 2009/00706 Responsible committee: CH/212 IVDs Interested committees: Title: Draft BS EN ISO 8536-3 Infusion equipment for medical use Part 3: Aluminium caps for infusion bottles Supersession infor
2、mation: If this document is published as a standard, the UK implementation of it will supersede BSENISO8536-3 : 1999 and partially supersede. NONE If you are aware of a current national standard which may be affected, please notify the secretary (contact details below). WARNING: THIS IS A DRAFT AND
3、MUST NOT BE REGARDED OR USED AS A BRITISH STANDARD. THIS DRAFT IS NOT CURRENT BEYOND 2 March 2009. This draft is issued to allow comments from interested parties; all comments will be given consideration prior to publication. No acknowledgement will normally be sent. See overleaf for information on
4、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 briefing purposes. Electronic circulation is limited to dissemination by e-mail withi
5、n 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 from BSI Customer Services. Information on the co-operating organizations represe
6、nted 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 be found via the British Standards Online Service on the BSI web site http:/.
7、Direct tel: 020 8996 7147 Responsible Committee Secretary: Mr F P Slot (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 Form 36 Version 8.0 DPC: 09/30197946 DC Licensed Copy: London South Bank University, S
8、outh Bank University, 02/02/2009 05:57, Uncontrolled Copy, (c) BSI b Introduction This draft standard is based on European discussions in which the UK has taken an active part. Your comments on this draft are welcome and will assist in the preparation of the consequent British Standard. Comment is p
9、articularly welcome on national, legislative or similar deviations that may be necessary. Even if this draft standard is not approved by the UK, if it receives the necessary support in Europe, the UK will be obliged to publish the official English Language text unchanged as a British Standard and to
10、 withdraw any conflicting 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 ensure that all comments receive efficient and appropriate attention by the responsible B
11、SI 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. Comments should be compatible with Version 6.0 or Version 97 of Microsoft Word for Window
12、s, 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 given in the example below. Further information on submitting comments and how to obtain a
13、 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 No./ Subclause No./ Annex (e.g. 3.1) Paragraph/ Figure/Table/ Note (e.g. Table 1) Type
14、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 read . so that the mains connector to which no connection . 6.4 Paragraph 2 te The use of
15、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 Windows is a trademark of Microsoft Corporation. Licensed Copy: London South Bank University,
16、 South Bank University, 02/02/2009 05:57, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM FINAL DRAFT FprEN ISO 8536-3 January 2009 ICS 11.040.20Will supersede EN ISO 8536-3:1999 English Version Infusion equipment for medical use - Part 3: Aluminium caps for infusion bot
17、tles (ISO/FDIS 8536-3:2009) Matriel de perfusion usage mdical - Partie 3: Capsules en aluminium pour flacons de perfusion (ISO/FDIS 8536- 3:2009) Infusionsgerte zur medizinischen Verwendung - Teil 3: Aluminium-Brdelkappen fr Infusionsflaschen (ISO/FDIS 8536-3:2009) This draft European Standard is su
18、bmitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee CEN/SS S02. If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard th
19、e 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 other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN
20、 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, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherland
21、s, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard. EUROPEAN
22、 COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. FprEN ISO 8536-3:2009: E Licensed Co
23、py: London South Bank University, South Bank University, 02/02/2009 05:57, Uncontrolled Copy, (c) BSI FprEN ISO 8536-3:2009 (E) 2 Contents Page Foreword 3? Licensed Copy: London South Bank University, South Bank University, 02/02/2009 05:57, Uncontrolled Copy, (c) BSI FprEN ISO 8536-3:2009 (E) 3 For
24、eword The text of ISO 8536-3:2009 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use” of the International Organization for Standardization (ISO) and has been taken over as FprEN ISO 8536-3:2009 by Technical Committee
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- 09 30197946 DC
链接地址:https://www.31doc.com/p-3726835.html