ISO 5359 AMD 1-2017 Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases Amendment 1《麻醉和呼吸器 医疗气体设备用低压软管组件 修改件1》.pdf

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1、 ISO 2017 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases AMENDMENT 1 Matriel danesthsie et de ranimation respiratoire Flexibles de raccordement basse pression pour utilisation avec les gaz mdicaux AMENDEMENT 1 INTERNATIONAL STANDARD ISO 5359 Fourth edit

2、ion 2014-10-01 Reference number ISO 5359:2014/Amd.1:2017(E) AMENDMENT 1 2017-07 ISO 5359:2014/Amd.1:2017(E)ii ISO 2017 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or

3、 utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester. ISO co

4、pyright office Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.org ISO 5359:2014/Amd.1:2017(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

5、ISO member bodies). The work of preparing International 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, g

6、overnmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further mai

7、ntenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

8、 Attention is drawn to the 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. Details of any patent rights identified during the development of the document will be in the Introd

9、uction and/or on the ISO list of patent declarations received (see www .iso .org/ patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the voluntary nature of standards, the meaning of ISO speci

10、fic terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: w w w . i s o .org/ iso/ foreword .html. This document was prepared by Technical Co

11、mmittee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines. ISO 2017 All rights reserved iii ISO 5359:2014/Amd.1:2017(E) Introduction This document has been prepared in response to the revision of ISO 7396-1, which applies in its thir

12、d edition also to oxygen supply systems in which all sources of supply deliver oxygen 93. Following this decision, ISO/TC 121/SC 1 approved developing the 1 stamendment to ISO 5359:2014 by replacing the term “oxygen-enriched air” by “oxygen 93” and by introducing the designation “O 293” for the medi

13、cal gas oxygen 93.iv ISO 2017 All rights reserved Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases AMENDMENT 1 Page 1, Scope Replace the text of the 8 thlist item that currently reads “oxygen-enriched air” by “oxygen 93”.Page 2, Clause 2 Replace the exist

14、ing definition 3.19 for oxygen-enriched air by the following: “3.19 oxygen 93 gas produced by an oxygen concentrator unit whose concentration is within the limits specified in the relevant pharmacopoeial monograph SOURCE: ISO 7396-1:2016, definition 3.46”Page 15, Table 1 1 stcolumn, 3 rdline, Replac

15、e “oxygen-enriched air” by “oxygen 93”; 2 ndcolumn, 3 rdline, Replace footnote “ c ” by “O 293”; In the table footnotes, replace: “ cSymbol and colour coding to be defined by national authorities.” by “ cColour coding to be defined by national authorities.” ISO 5359:2014/Amd.1:2017(E) ISO 2017 All rights reserved 1 ISO 5359:2014/Amd.1:2017(E) ISO 2017 All rights reserved ICS 11.040.10; 83.140.40 Price based on 1 page

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