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
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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
25、neous, assisted or controlled ventilation. 1.2 This International Standard specifies the dimensions, basic properties and method of size designation of the available types of supralaryngeal airways. Airways devised for specialized applications are not specifically covered, although most may be class
26、ified by the sizing and dimensions (or other characteristics) required by this International Standard. 1.3 The following devices are outside the scope of this International Standard: nasal and oropharyngeal airways, anesthetic masks, oro- and naso-tracheal tubes, cricothyrotomy devices, dental appli
27、ances, tracheal stents, tracheal tubes, ventilating laryngoscopes, CPAP devices, esophageal obturators, bougies and devices that require surgical placement. 1.4 This International Standard requires dimensional disclosure so the operator will know which auxiliary instruments, such as tracheal tubes a
28、nd bronchoscopes will be size-compatible. 1.5 Flammability of airways, for example if used with certain flammable anesthetics, electrosurgical units or lasers, is a well-recognized hazard that is outside the scope of this International Standard. See E.1.7. 2 Normative references The following refere
29、nced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, nee
30、dles and certain other medical equipment Part 1: General requirements ISO 4135, Anaesthetic and respiratory equipment Vocabulary ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets ISO 5361:1999, Anaesthetic and respiratory equipment Tracheal tubes and conn
31、ectors ISO 7000, Graphical symbols for use on equipment Index and synopsis ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 11607:2003, Packaging for terminally sterilized medical devices ISO 11134, Sterilization of health care
32、 products Requirements for validation and routine control Industrial moist heat sterilization BS ISO 11712:2009ISO 11712:2009(E) 2 ISO 2009 All rights reservedISO 11135:1994, Medical Devices Validation and routine control of ethylene oxide sterilization ISO 11137-1, Sterilization of health care prod
33、ucts Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11990, Optics and optical instruments Lasers and laser-related equipment Determination of laser resistance of tracheal tube shafts ISO/TR 11991, Guidance on airway m
34、anagement during laser surgery of upper airway ISO 14155-1, Clinical investigation of medical devices for human subjects Part 1: General requirements ISO 14155-2, Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans ISO 14408, Tracheal tubes designed for
35、laser surgery Requirements for marking and accompanying information 3 Terms and definitions For the purposes of this document, the terms and definitions in ISO 4135 and the following apply. 3.1 auxiliary ventilatory opening secondary opening in the ventilatory pathway intended for passage of ventila
36、tory gases at or near the patient end 3.2 cuff compliant seal permanently attached to the supralaryngeal airway to provide a seal between the tube and the oropharynx 3.3 external seal seal that is positioned outside the patient EXAMPLE A seal between a face mask and the face. 3.4 internal seal seal
37、that is positioned inside the patient at some point in the respiratory tract NOTE For supralaryngeal airways the internal seal is typically located in proximity to the glottic inlet. 3.5 patency openness (lack of obstruction) of the supralaryngeal airway 3.6 patient end that end of the supralaryngea
38、l airway intended to be inserted into the patient 3.7 machine end that end of the supralaryngeal airway or the supralaryngeal airway connector intended to connect to the breathing system BS ISO 11712:2009ISO 11712:2009(E) ISO 2009 All rights reserved 33.8 pressure drop pressure differential at a spe
39、cified flow 3.9 sealing mechanism that portion of the device in contact with the patient that enables isolation of ventilatory gases 3.10 supralaryngeal airway device placed through the mouth but not through the vocal cords, which is intended to form an internal seal in the supralaryngeal area to ma
40、intain airway patency 3.11 supralaryngeal airway connector tubular component of an supralaryngeal airway intended for connection to a breathing system or ventilation bag 3.12 ventilatory opening opening in the supralaryngeal airway near the patient end and intended to allow passage of gases and/or d
41、evices such as a tracheal tube, suction catheter or endoscope NOTE A supralaryngeal airway can have more than one ventilatory opening. 3.13 ventilatory pathway part of the supralaryngeal airway through which gases are intended to pass 4 General requirements 4.1 This International Standard specifies
42、requirements that are generally applicable to risks associated with supralaryngeal airways. An established risk management process shall be applied to the design of the device. See Annex D for an informative list of identified hazards. 4.2 The supralaryngeal airway shall permit ventilation in those
43、head and neck positions, and in those patient positions for which the device is intended. 4.3 The supralaryngeal airway shall permit ventilation when the patient is in the supine position and the head and neck are at neutral positions and at least 30 of: a) flexion; b) extension; c) right and left r
44、otation; d) right and left lateral flexion (tilt). 4.4 The supralaryngeal airway shall also permit ventilation in the following positions and in any position intended for use: a) Trendelenburgs (head down, 10); b) sitting (45). Compliance shall be tested by examination of the mitigations described i
45、n a risk assessment and associated verification and validation studies. NOTE 1 See Annex A and Annex D. BS ISO 11712:2009ISO 11712:2009(E) 4 ISO 2009 All rights reservedIf clinical studies are performed, these studies shall document measurements taken during the conditions for which performance is c
46、laimed. The clinical studies shall comply with the requirements of ISO 14155-1, and ISO 14155-2. NOTE 2 See also Annex B for evaluating and documenting the clinical performance of supralaryngeal airways in human subjects. 4.5 The supralaryngeal airway shall, when transported, stored and used as inte
47、nded by the manufacturer, minimize safety hazards which could reasonably be foreseen in normal and single-fault condition. 4.6 Where the requirements of this International Standard refer to freedom from unacceptable risk, acceptability or unacceptability of this risk is determined by the manufacture
48、r in accordance with the manufacturers policy for determining acceptable risk. 4.7 The manufacturer may use type tests different from those detailed within this International Standard, if an equivalent degree of safety is obtained. However, in the event of dispute, the methods specified herein shall
49、 be used as the reference methods. 4.8 Many of the test clauses within this International Standard establish acceptance criteria for performance aspects. These acceptance criteria shall always be met. If the manufacturer chooses to specify in the accompanying documents higher performance levels than those specified within this International Standard these manufacturer-specified levels become the acceptance levels and shall also be met. 5 *Requirements 5.1 Supralaryngeal airways 5.1.1 *Size designation
