ANSI AAMI 5364-2008 Anaesthetic and respiratory equipment-Oropharyngeal airways.pdf

1、ANSI/AAMI/ISO 5364: 2008Anaesthetic and respiratory equipmentOropharyngeal airways 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, so there are some variatio

2、ns 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 publication is subject to cop

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6、570205426 Approved as an American National Standard with deviations by ASTM International INTERNATIONAL ANSI/ISOSTANDARD 5364Fourth edition 2008-07-15 Anaesthetic and respiratory equipment Oropharyngeal airways Matriel danesthsie et de reanimation respiratoire Canules oropharynges ASTM International

7、 Approved as an American National Standard with deviations by ASTM International ANSI/ISO 5364:2008(E) MOD in ANSI/ISO 5364 means that ASTM International has approved the standard as an American National Standard with deviations. The U.S. deviations are appended to the end of ANSI/ISO 5364. These ma

8、terials 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 electronic retrieval system, without the prior written permission of ASTM International. i

9、i ASTM InternationalApproved as an American National Standard with deviations by ASTM International ANSI/ISO 5364:2008(E)Contents Page1 Scope . 1 2 Normative references . 1 3 Terms and definitions . 1 4 Size designation and dimensions . 2 5 Materials 3 6 Design 3 7 Performance requirements . 3 8 Ste

10、rility assurance 4 9 Packaging of oropharyngeal airways supplied sterile . 4 10 Marking 4 11 Information to be supplied by the manufacturer . 5 Annex A (normative) Test method for resistance to collapse of the buccal portion . 6Annex B (normative) Test method for patency of lumen . 8Annex C (informa

11、tive) Guidance on materials and design . 10Bibliography . 11 ASTM International iii Approved as an American National Standard with deviations by ASTM International ANSI/ISO 5364:2008(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bo

12、dies (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 organizatio

13、ns, 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 the rules given in the

14、ISO/IEC Directives, Part 2. 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 by at least 75 % of th

15、e member bodies casting a vote. 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. ISO 5364 was prepared by Technical Committee ISO/TC 121, Anaesthetic

16、and respiratory equipment,Subcommittee SC 2, Tracheal tubes and other equipment.This fourth edition cancels and replaces the third edition (ISO 5364:2001), which has been technically revised. iv ASTM InternationalApproved as an American National Standard with deviations by ASTM International ANSI/IS

17、O 5364:2008(E)IntroductionThis International Standard specifies dimensions and other requirements for oropharyngeal airways. Airway size is designated by length, which is important when selecting an oropharyngeal airway to hold forward the base of the tongue to prevent obstruction of the airway by t

18、he soft tissues. ASTM InternationalvApproved as an American National Standard with deviations by ASTM International .INTERNATIONAL STANDARD ANSI/ISO 5364:2008(E)Anaesthetic and respiratory equipment Oropharyngeal airways1 ScopeThis International Standard specifies requirements for oropharyngeal airw

19、ays of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal. This International Standard is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways. Flammability of oropharyng

20、eal airways, for example if flammable anaesthetics, electrosurgical units or lasers are used, is a well-recognized hazard. It is addressed by appropriate clinical management, which is outside the scope of this International Standard. This International Standard is not applicable to supralaryngeal ai

21、rways without an internal, integral sealing mechanism. 2 Normative referencesThe following referenced 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 (includi

22、ng any amendments) applies. ISO 7000, Graphical symbols for use on equipment Index and synopsisISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements fo

23、r materials, sterile barrier systems and packaging systemsEN 556-1:2001, Sterilization of medical devices Requirements for medical devices to be designated “STERILE” Part 1: Requirements for terminally sterilized medical devicesEN 980, Graphical symbols for use in the labelling of medical devicesEN

24、1041, Information supplied by the manufacturer with medical devices3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply. 3.1oropharyngeal airwaydevice intended to maintain a gas pathway through the oral cavity and pharynx ISO 4135 ASTM International 1Ap

25、proved as an American National Standard with deviations by ASTM International ANSI/ISO 5364:2008(E)3.2 pharyngeal endthat end of an oropharyngeal airway which is intended to be inserted into a patients oropharynx ISO 4135 3.3 flanged endthat end of an oropharyngeal airway which is flanged and is int

26、ended to be external to the teeth or gums ISO 4135 4 Size designation and dimensions4.1 Size designationThe size of oropharyngeal airways shall be designated by the nominal length (see l, Figure 1) expressed in centimetres, in accordance with Table 1. NOTE The manufacturers own size designation may

27、additionally be given, but this is not recommended. Key1 buccal portion 2 reinforcement insert, if provided 3 position for measuring minimum inside dimension (see Table 1) 4 flanged end aFor l see 4.1 and 4.2.1. Figure 1 Dimensions for size designation of oropharyngeal airways2 ASTM InternationalApp

28、roved as an American National Standard with deviations by ASTM International ANSI/ISO 5364:2008(E)Table 1 Size designation of oropharyngeal airways Dimensions and tolerancesDesignated size (nominal length),Length and tolerance, Minimum inside dimension,cm mm mm3 30 2,5 2,53,5 35 2,5 3,04 40 2,5 3,04

29、,5 45 2,5 3,05 50 2,5 3,55,5 55 2,5 3,56 60 2,5 4,06,5 65 2,5 4,07 70 +5,0-2,54,0 8 80 5,0 4,59 90 5,0 4,510 5,011 5,512100 5,0 110 5,0 120 5,05,54.2 Dimensions4.2.1 The length (see l, Figure 1) shall be in accordance with Table 1.4.2.2 The minimum inside dimension at any point along the length of t

30、he airway shall be not less than that specified in Table 1.NOTE This dimension is relevant to the ability to pass other devices, e.g. a suction catheter, through the airway. 5 MaterialsOropharyngeal airways, in their ready-for-use state after any preparation for use recommended by the manufacturer,

31、shall satisfy appropriate biological safety testing, as indicated in ISO 10993-1. 6 DesignEdges and corners intended to come into contact with the patients tissues shall have a minimum radius of curvature of 0,5 mm. 7 Performance requirements7.1 Resistance to collapse of the buccal portionWhen teste

32、d in accordance with Annex A, the minimum inside dimension of the buccal portion of the airway shall be not less than 75 % of that given in Table 1 for the size of the airway being tested. 7.2 Patency of lumenWhen tested in accordance with Annex B, the patency of the oropharyngeal airway lumen shall

33、 be maintained. ASTM International 3Approved as an American National Standard with deviations by ASTM International ANSI/ISO 5364:2008(E)8 Sterility assuranceOropharyngeal airways supplied and marked “STERILE” shall satisfy the requirements of 4.1 of EN 556-1:2001. 9 Packaging of oropharyngeal airwa

34、ys supplied sterile9.1 Each oropharyngeal airway supplied and marked “STERILE” shall be contained in an individual pack.9.2 The pack shall serve as an effective barrier to the penetration of micro-organisms and particulate material in accordance with ISO 11607-1.9.3 The pack shall permit the aseptic

35、 extraction of the contents and shall not be capable of re-closure without clearly revealing that it has been opened.9.4 The designated size of the airway shall be apparent on visual examination of the intact unit container.9.5 Individual packs shall be contained within a shelf or multi-unit pack.10

36、 Marking10.1 GeneralMarking of oropharyngeal airways, of unit packs and of shelf or multi-unit packs and information to be supplied by the manufacturer should comply with EN 1041. 10.2 Use of symbolsThe requirements of 10.4 and 10.5 may be met by use of appropriate symbols as given in ISO 7000 or EN

37、 980. 10.3 Marking of oropharyngeal airways10.3.1 The flanged end of the oropharyngeal airway shall be marked with the following: a) the designated size (nominal length, in centimetres) in accordance with 4.1 (see Figure 2); b) the name and/or trade mark of the manufacturer and/or supplier (see Figu

38、re 2). 10.3.2 Markings in accordance with a) and b) shall be visible from the flanged end. 10.4 Marking of unit packsThe marking of individual packs or a package insert shall include the following: a) the word “STERILE”, if appropriate. It is recommended that the method of sterilization be given; b)

39、 for oropharyngeal airways not intended for re-use, the words “single use” or equivalent; c) an indication of the presence of natural rubber (latex), if present in the device. 4 ASTM InternationalApproved as an American National Standard with deviations by ASTM International ANSI/ISO 5364:2008(E)Key

40、1 designated size 2 name and/or trademark of manufacturer or supplier NOTE The designs shown in Figures 1 and 2 are intended to illustrate common types of oropharyngeal airway for the purpose of size designation and marking, but are for example only. Figure 2 Typical marking locations on flanged end

41、 of oropharyngeal airways10.5 Marking of shelf or multi-unit packsThe marking of shelf or multi-unit packs shall include the following: a) a description of contents; b) the designated size in accordance with 4.1; c) the name and/or trademark and address of the manufacturer and/or supplier; d) the ba

42、tch number; e) the word “STERILE”, if appropriate; It is recommended that the method of sterilization be given. f) for oropharyngeal airways not intended for re-use, the words “single use” or equivalent; It is strongly recommended that the “use by” date be given. 11 Information to be supplied by the

43、 manufacturer11.1 Unless the oropharyngeal airway is intended and marked as being for single use, the manufacturer shall recommend methods of cleaning and disinfection or sterilization.11.2 The manufacturer shall indicate the presence of natural rubber (latex), if present in the device. ASTM Interna

44、tional 5Approved as an American National Standard with deviations by ASTM International ANSI/ISO 5364:2008(E)Annex A(normative)Test method for resistance to collapse of the buccal portionA.1 PrincipleThe resistance of the buccal portion to collapse is tested by measuring the minimum inside dimension

45、 during compression. A.2 ApparatusA.2.1 Means of conditioning the oropharyngeal airway at (34 2)C and carrying out the test under the same conditions. A.2.2 Means of applying a force of either (100 10) N or (200 20) N, as appropriate. A.2.3 Means of measuring the minimum inside dimension of the bucc

46、al portion during compression, with an accuracy of 0,10 mm. A.3 Test procedureA.3.1 Condition the oropharyngeal airway at (34 2)C for 1 h and carry out the test under the same conditions. A.3.2 Compress the middle of the buccal portion (see Figure 1) of the oropharyngeal airway using blocks with a (

47、60 2)included angle and radius of curvature of (1,0 0,5) mm to the mating surfaces and a width at least as great as that of the buccal portion of the airway being tested (see Figure A.1). A.3.3 For oropharyngeal airways of designated size 5,5 or smaller, apply a force of (100 10) N and maintain that

48、 force for 3 min whilst measuring the minimum dimension. A.3.4 For oropharyngeal airways of designated size 6,0 or larger, apply a force of (200 20) N and maintain that force for 3 min whilst measuring the minimum dimension. A.4 Expression of resultExpress the minimum inside dimension of the buccal portion during compression as a percentage of that value specified in Table 1 for the size of airway being tested. 6 ASTM InternationalApproved as an American National Standar