ANSI AAMI 10651-4-2002 Lung ventilators-Part 4 Particular requirements for operator-powered resuscitators.pdf
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1、ANSI/AAMI/ISO 10651-4:2002Lung ventilatorsPart 4: Particular requirements for operator-powered resuscitators American National StandardThis document was approved and published when the U.S. TAG for TC 121 was held by ASTM, but it is now an AAMI standard. The original formatting has been maintained,
2、so there are some variations from the typical AAMI style. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2014 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This pub
3、lication is subject to copyright claims of ISO, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this document should be submitted to AAMI. It is ille
4、gal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penal
5、ties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: 703-525-4890; Fax: 703-525-1067. Printed in the Unite
6、d States of America ISBN 1570205396 Approved as an American National Standard with deviations by ASTM International INTERNATIONAL ANSI/ISO STANDARD 10651-4 First edition 2002-03-01 Lung ventilators Part 4: Particular requirements for operator-powered resuscitators Ventilateurs pulmonaires Partie 4 :
7、 Exigences relatives aux ressuscitateurs puissance motrice manuelle ASTM International Approved as an American National Standard with deviations by ASTM International ANSI/ISO 10651-4 MOD in ANSI/ISO 10651-4 means that ASTM International has approved the standard as an American National Standard wit
8、h deviations. The U.S. deviations are appended to the end of ANSI/ISO 10651-4. These materials are subject to copyright claims of ASTM International. Not for resale without the prior written permission of ASTM International. No part of this publication may be reproduced in any form, including an ele
9、ctronic retrieval system, without the prior written permission of ASTM International. ii ASTM International Approved as an American National Standard with deviations by ASTM International ANSI/ISO 10651-4 Foreword ISO (the International Organization for Standardization) is a worldwide federation of
10、national standards bodies (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. Inte
11、rnational organizations, governmental 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. International Standards are drafted in accordance with th
12、e rules given in the ISO/IEC Directives, Part 3. The main task of technical committees 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 b
13、y at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this part of ISO 10651 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10651-4 was prepared by the Europea
14、n Committee for Standardization (CEN) in collaboration with Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). Throughout t
15、he text of this document, read “.this European Standard.“ to mean “.this International Standard.“. ISO 10651 consists of the following parts, under the general title Lung ventilators: Part 1: Requirements Part 2: Particular requirements for home care ventilators Part 3: Particular requirements for e
16、mergency and transport ventilators Part 4: Particular requirements for operator-powered resuscitators Annex A forms a normative part of this part of ISO 10651. Annex B is for information only. For the purposes of this part of ISO 10651, the CEN annex regarding fulfilment of European Council Directiv
17、es has been removed. ASTM International iii Approved as an American National Standard with deviations by ASTM International ANSI/ISO 10651-4 Contents Page Forewordv 1 Scope .1 2 Normative references .1 3 Terms and definitions.1 4 Connectors 3 5 Operational requirements 3 6 Ventilatory requirements4
18、7 Storage and operating conditions.6 8 Requirements for resuscitator, or parts, supplied sterile .6 9 Marking 6 10 Information to be provided by the manufacturer in operating and maintenance instructions .7 Annex A (normative) Test methods9 Annex B (informative) Rationale19 Bibliography22 iv ASTM In
19、ternational Approved as an American National Standard with deviations by ASTM International ANSI/ISO 10651-4Foreword This document (EN ISO 10651-4:2002) has been prepared by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment“, the secretariat of which is held by BSI, in collaborat
20、ion with Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment“. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2002, and conflicting national standards shall be withdra
21、wn at the latest by September 2002. 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 EU Directive(s). Annex A is normative and form part of this European Standard. Annex B is for in
22、formation only. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard : Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta,
23、Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. ASTM International v Approved as an American National Standard with deviations by ASTM International Approved as an American National Standard with deviations by ASTM International ANSI/ISO 10651-4 1 Scope This Europea
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