BS ISO 11712-2009 Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors《麻醉和呼吸设备 上喉气道和连接器》.pdf
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1、BS ISO11712:2009ICS 11.040.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDAnaesthetic andrespiratory equipment Supralaryngealairways andconnectorsThis British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 30 June 200
2、9 BSI 2009ISBN 978 0 580 60877 3Amendments/corrigenda issued since publicationDate CommentsBS ISO 11712:2009National forewordThis British Standard is the UK implementation of ISO 11712:2009.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/5, Lung ventilators, trache
3、al tubes and relatedequipment.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard
4、cannot confer immunityfrom legal obligations.BS ISO 11712:2009Reference numberISO 11712:2009(E)ISO 2009INTERNATIONAL STANDARD ISO11712First edition2009-05-15Anaesthetic and respiratory equipment Supralaryngeal airways and connectors Matriel danesthsie et de ranimation respiratoire Canules supralaryn
5、ges et raccords BS ISO 11712:2009ISO 11712:2009(E) 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 licensed to and installed on the computer
6、 performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create t
7、his PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Cen
8、tral Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2009 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permissio
9、n in writing from either ISO at the address below or ISOs member 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 Published in Switzerland ii ISO 2009 All rights reservedB
10、S ISO 11712:2009ISO 11712:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 General requirements. 3 5 *Requirements. 4 5.1 Supralaryngeal airways 4 5.1.1 *Size designation 4 5.1.2 Materials 4 5.1.3 *Ve
11、ntilatory opening. 4 5.1.4 *Safeguards against collapse of the ventilatory pathway 5 5.1.5 *Sealing mechanism. 5 5.1.6 *Internal volume 5 5.1.7 Maximum instrument size 5 5.2 Supralaryngeal airway connectors . 6 6 Requirements for supralaryngeal airways and connectors supplied sterile . 6 6.1 Sterili
12、ty assurance 6 6.2 Packaging for supralaryngeal airways and connectors supplied sterile 6 7 Cleaning and disinfection or sterilization 6 8 Markings 6 8.1 Use of symbols . 6 8.2 Marking of the supralaryngeal airway 6 8.3 Marking on the supralaryngeal airway individual pack 7 9 Accompanying documents
13、7 Annex A (informative) Rationale . 10 Annex B (normative) Evaluation and documentation of the clinical performance in human subjects . 15 Annex C (normative) Test methods to determine kink resistance 17 Annex D (informative) Hazard identification for risk assessment. 22 Annex E (informative) Guidan
14、ce on materials and design. 26 Bibliography . 28 BS ISO 11712:2009ISO 11712:2009(E) iv ISO 2009 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standar
15、ds 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 ISO, also take
16、 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 committees is
17、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 the possibility
18、 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. ISO 11712 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 2, Tracheal tubes and oth
19、er equipment. BS ISO 11712:2009ISO 11712:2009(E) ISO 2009 All rights reserved vIntroduction * A supralaryngeal airway is a device placed through the mouth, intended to seal the supralaryngeal area to maintain airway patency without passing through the vocal cords and to independently facilitate vent
20、ilation with or without delivery of anesthesia gases. Devices intended to provide a breathing airway and/or to simultaneously provide a guide for the intubation of tracheal tubes, bronchoscopes and suction devices are also included in the scope of this International Standard, as are the connectors i
21、nserted into the machine end of these devices. * Examples of supralaryngeal airway devices are laryngeal masks, laryngeal tubes, airways and seals, cuffed oropharyngeal airways, and pharyngeal airways, and combination airway/esophageal obturators. The requirements of this International Standard were
22、 developed using the hazard identification for risk assessment in Annex D. The requirements for testing and disclosure apply to devices introduced to the market after the publication of this International Standard. Throughout this International Standard, terms defined in ISO 4135 or in this Internat
23、ional Standard appear in bold type. Throughout this International Standard, text for which a rationale is provided in Annex A is indicated by an asterisk (*). BS ISO 11712:2009BS ISO 11712:2009INTERNATIONAL STANDARD ISO 11712:2009(E) ISO 2009 All rights reserved 1Anaesthetic and respiratory equipmen
24、t Supralaryngeal airways and connectors 1 Scope 1.1 This International Standard provides the essential requirements for the design of supralaryngeal airways and connectors. These devices are intended to open and seal the supralaryngeal area to provide an unobstructed airway in patients during sponta
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