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1、a Date: 9 September 2008 Origin: European Latest date for receipt of comments: 22 December 2008 Project no.: 2008/00272 Responsible committee: CH/121/6 Medical gas supply systems Interested committees: Title: Draft BS ENISO 7396-1 AMD 1 Medical gas pipeline systems Part 1: Pipeline systems for compr
2、essed medical gasses and vacuum Supersession information: If this document is published as a standard, the UK implementation of it will supersede BSENISO7396-1 : 2007 and partially supersede. NONE If you are aware of a current national standard which may be affected, please notify the secretary (con
3、tact details below). WARNING: THIS IS A DRAFT AND MUST NOT BE REGARDED OR USED AS A BRITISH STANDARD. THIS DRAFT IS NOT CURRENT BEYOND 22 December 2008. This draft is issued to allow comments from interested parties; all comments will be given consideration prior to publication. No acknowledgement w
4、ill 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 briefing purposes. Electronic c
5、irculation 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 from BSI Customer Services.
6、 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 be found via the British
7、 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 Form 36 Version 8.0 DPC:
8、 08/30176779 DC Licensed CopyChinese University of Hong Kong, 21/10/2008 08:04, 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 c
9、onsequent British Standard. If no comments are received to the contrary, then the UK will approve this draft and implement it as a British Standard. Comment is particularly welcome on national, legislative or similar deviations that may be necessary. Even if this draft standard is not approved by th
10、e 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 withdraw any conflicting standard. UK Vote Please indicate whether you consider the UK should submit a negative (with reasons) or positive
11、 vote on this draft. Submission The guidance given below is intended to ensure 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 R
12、esponsible 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 Windows, if possible; otherwise comments in ASCII text format are acceptable. Any comments not submitted electronically should still adhere to th
13、ese format requirements. All comments submitted should be presented as given 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 observatio
14、ns 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 of com- ment Comment (justification for change) by the MB Proposed change by the MB Secretariat observations on each comment submitted 3.1
15、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 the UV photometer as an alternative cannot be supported as serious problems have been encountered in its use in the UK. Delete reference to
16、 UV photometer. Microsoft and MS-DOS are registered trademarks, and Windows is a trademark of Microsoft Corporation. Licensed CopyChinese University of Hong Kong, 21/10/2008 08:04, Uncontrolled Copy, (c) BSI THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHA
17、NGE AND MAY NOT BE REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH. IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO
18、 BECOME STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS. RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION. DRAFT AMENDMENT ISO 7396-1:2007/DAmd 1 Internatio
19、nal Organization for Standardization, 2008 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ORGANISATION INTERNATIONALE DE NORMALISATION ISO/TC 121/SC 6 Voting begins on: 2008-09-04 Secretariat: ANSI Voting terminates on: 2009-02-04 Medical gas pipeline systems Part 1: Pipeline systems for compressed
20、medical gases and vacuum AMENDMENT 1 Systmes de distribution de gaz mdicaux Partie 1: Systmes de distribution de gaz mdicaux comprims et de vide AMENDEMENT 1 ICS 11.040.10 ISO/CEN PARALLEL ENQUIRY The CEN Secretary-General has advised the ISO Secretary-General that this ISO/DIS covers a subject of i
21、nterest to European standardization. In accordance with the ISO-lead mode of collaboration as defined in the Vienna Agreement, consultation on this ISO/DIS has the same effect for CEN members as would a CEN enquiry on a draft European Standard. Should this draft be accepted, a final draft, establish
22、ed on the basis of comments received, will be submitted to a parallel two-month FDIS vote in ISO and formal vote in CEN. To expedite distribution, this document is circulated as received from the committee secretariat. ISO Central Secretariat work of editing and text composition will be undertaken a
23、t publication stage. Pour acclrer la distribution, le prsent document est distribu tel quil est parvenu du secrtariat du comit. Le travail de rdaction et de composition de texte sera effectu au Secrtariat central de lISO au stade de publication. Licensed CopyChinese University of Hong Kong, 21/10/20
24、08 08:04, Uncontrolled Copy, (c) BSI ISO 7396-1:2007/DAmd 1 ii ISO 2008 All rights reserved PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are
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27、ing to it is found, please inform the Central Secretariat at the address given below. Copyright notice This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted under the applicable laws of the users country, neither this ISO draft nor any extract fro
28、m it may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, without prior written permission being secured. Requests for permission to reproduce should be addressed to either ISO at the address below or ISOs membe
29、r body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Reproduction may be subject to royalty payments or a licensing agreement. Violators may be prosecuted. Licensed CopyChin
30、ese University of Hong Kong, 21/10/2008 08:04, Uncontrolled Copy, (c) BSI ISO 7396-1:2007/DAM1 ISO 2008 All rights reserved iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Internat
31、ional Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with I
32、SO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical c
33、ommittees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to th
34、e possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Amendment to ISO 7396-1: was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee
35、SC 6, Medical gas systems. Licensed CopyChinese University of Hong Kong, 21/10/2008 08:04, Uncontrolled Copy, (c) BSI Licensed CopyChinese University of Hong Kong, 21/10/2008 08:04, Uncontrolled Copy, (c) BSI ISO 2008 All rights reserved 1 Medical gas pipeline systems Part 1: Pipeline systems for co
36、mpressed medical gases and vacuum Amendment 1, Requirements for terminal units for vacuum fitted on medical supply units with operator-adjustable portions and connected to the pipeline through flexible hoses Page 39, subclause 12.6.4 Add the following text after Table 4: For terminal units for vacuu
37、m fitted on medical supply units with operator-adjustable portions and connected to the pipeline through flexible hoses, the pressure change shall be such as to limit the pressure measured at the terminal unit with the test flowrate of 25 l/min to not more than 60 kPa absolute pressure. ISO 7396-1:2
38、007/DAM1 DRAFT AMENDMENT Licensed CopyChinese University of Hong Kong, 21/10/2008 08:04, Uncontrolled Copy, (c) BSI Annex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical devices By agreement between ISO and CEN, th
39、is CEN annex is included in the DIS and the FDIS but will not appear in the published ISO standard. This International Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements
40、 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 standard in at least one Member State, compliance with the clauses and within the limits of the sco
41、pe of this Intenational Standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this International Standar
42、d. 2 ISO 2008 All rights reserved ISO 7396-1:/PDAM Licensed CopyChinese University of Hong Kong, 21/10/2008 08:04, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM DRAFT EN ISO 7396-1:2007 prA1 September 2008 ICS 11.040.10 English Version Medical gas pipeline systems - Pa
43、rt 1: Pipeline systems for compressed medical gases and vacuum - Amendment 1 (ISO 7396-1:2007/DAmd 1:2008) Systmes de distribution de gaz mdicaux - Partie 1: Systmes de distribution de gaz mdicaux comprims et de vide - Amendement 1 (ISO 7396-1:2007/DAmd 1:2008) Rohrleitungssysteme fr medizinische Ga
44、se - Teil 1: Rohrleitungssysteme fr medizinische Druckgase und Vakuum - nderung 1: Anforderungen an Entnahmestellen fr Vakuum, die an medizinische Versorgungseinheiten mit vom Anwender einstellbaren Abschnitten angebracht und durch flexibles Schluche mit der Rohrleitung verbunden sind (ISO 7396-1:20
45、07/DAmd 1:2008) This draft amendment is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee CEN/TC 215. This draft amendment A1, if approved, will modify the European Standard EN ISO 7396-1:2007. If this draft becomes an amendment, CEN members are bound to
46、comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment into the relevant national standard without any alteration. This draft amendment was established by CEN in three official versions (English, French, German). A version in any other languag
47、e 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, Estonia, Finland,
48、 France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation. 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