ANSI AAMI 5356-1-2004 Anaesthetic and respiratory equipment-Conical connectors-Part 1 Cones and sockets.pdf

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1、ANSI/AAMI/ISO 5356-1: 2004Anaesthetic and respiratory equipmentConical connectorsPart 1: Cones and sockets 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

2、 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 publi

3、cation 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 illega

4、l 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 penalti

5、es, 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 United

6、States of America ISBN 1570205329 Approved as an American National Standard with deviations by ASTM InternationalASTM InternationalINTERNATIONALSTANDARDANSI/ISO5356-1(MOD)Third edition2004-05-15Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets Matriel danesthsie et d

7、e ranimation respiratoire Raccords coniques Partie 1: Raccords mles et femelles Approved as an American National Standard with deviations by ASTM InternationalANSI/ISO 5356-1:2004(E) MOD in ANSI/ISO 5356-1 means that ASTM International has approved the standard as an American National Standard with

8、deviations. The U.S. deviations are appended to the end of ANSI/ISO 5356-1. ASTM International 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,

9、including an electronic retrieval system, without the prior written permission of ASTM International. ii ASTM International Approved as an American National Standard with deviations by ASTM InternationalANSI/ISO 5356-1:2004(E) ASTM International iiiContents PageForeword .ivIntroductionv1 Scope.12 No

10、rmative references .13 Terms and definitions.24 Conical connectors made of metal24.1 General requirements.24.2 Additional requirements for male conical connectors of 22 mm size 24.3 Additional requirements for conical connectors of 8,5 mm size.45 Conical connectors made of materials other than metal

11、 .45.1 General requirements.45.2 Additional requirements for conical connectors of 22 mm size45.3 Additional requirements for conical connectors of 8,5 mm size.46 22 mm latching connectors4Annex A (normative) Plug and ring test gauges for conical connectors made of materials other than metal6Annex B

12、 (normative) Test for security of engagement of 22 mm latching connector to male conical connector .8Annex C (normative) Test for leakage from 22 mm latching connectors 9Annex D (normative) Drop procedure for 22 mm latching connectors10Annex E (informative) Plug and ring test gauges for conical conn

13、ectors made of metal 11Annex F (informative) Suggested apparatus and methods for testing the security of engagement of 22 mm latching connectors .13Bibliography.17Approved as an American National Standard with deviations by ASTM InternationalANSI/ISO 5356-1:2004(E) iv ASTM InternationalForeword ISO

14、(the International Organization for Standardization) is a worldwide federation of 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 comm

15、ittee has been established has the right to be represented on that committee. International 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 electrote

16、chnical 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 to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the memb

17、er 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 that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifyi

18、ng any or all such patent rights. ISO 5356-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,Subcommittee SC 1, Breathing attachments and anaesthetic machines.This third edition cancels and replaces the second edition (ISO 5356-1:1996), which has been technicall

19、y revised. The major differences are the inclusion of 8,5 mm size connectors and some minor corrections to the figures and tables. ISO 5356 consists of the following parts, under the general title Anaesthetic and respiratory equipment Conical connectors: Part 1: Cones and sockets Part 2: Screw-threa

20、ded weight-bearing connectors Approved as an American National Standard with deviations by ASTM InternationalANSI/ISO 5356-1:2004(E) ASTM International vIntroductionIn clinical practice, several breathing attachments used in anaesthetic and respiratory equipment may have to be joined together to pro

21、vide a suitable breathing system. Items of medical equipment, such as a humidifier or a spirometer, are often incorporated into the breathing system which may also be connected to an anaesthetic-gas scavenging system. Connections for these purposes are usually cone and socket joints, and a lack of s

22、tandardization of these connections has given rise to problems of interchangeability when connecting equipment made by different manufacturers. This part of ISO 5356 specifies the requirements and dimensions for conical connectors used in anaesthetic and respiratory equipment. An important considera

23、tion is that conical connections need to be secure but nevertheless disconnectable by the operator. The use of connectors meeting the requirements of this part of ISO 5356 will not necessarily prevent them being disconnected accidentally. To minimize the risk of 22 mm connectors being accidentally d

24、isconnected, latching connectors can be used. Annex A includes a figure and a table detailing plug and ring test gauges that are used to check conical connectors made of materials other than metal. Annexes B, C and D provide test methods for latching connectors, Annex E includes a figure and table d

25、etailing plug and ring test gauges that may be used to check metal conical connectors, and Annex F contains recommendations for testing security of latching connectors. Figure 1, detailing the dimensions and tolerances of metal conical connectors, has been prepared in accordance with ISO 3040. Appro

26、ved as an American National Standard with deviations by ASTM International INTERNATIONAL STANDARD ANSI/ISO 5356-1:2004(E) ASTM International 1Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets 1 Scope This part of ISO 5356 specifies dimensional and gauging requirement

27、s for cones and sockets intended for connecting anaesthetic and respiratory equipment, e.g. in breathing systems, anaesthetic-gas scavenging systems and vaporizers. This part of ISO 5356 gives requirements for the following conical connectors: 8,5 mm size intended for use in paediatric breathing sys

28、tems; 15 mm and 22 mm sizes intended for general use in breathing systems; 22 mm latching connectors (including performance requirements); 23 mm size intended for use with vaporizers, but not for use in breathing systems; 30 mm size intended for the connection of a breathing system to an anaesthetic

29、 gas scavenging system. This part of ISO 5356 does not specify the medical devices and accessories on which these connections are to be provided. Requirements for the application of conical connectors are not included in this part of ISO 5356, but are or will be given in the relevant International S

30、tandards for specific medical devices and accessories. NOTE Requirements for screw-threaded weight-bearing conical connectors are specified in ISO 5356-2. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the

31、edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 4135, Anaesthetic and respiratory equipment VocabularyISO 5367, Breathing tubes intended for use with anaesthetic apparatus and ventilatorsIEC 60601-1:1988, Medical el

32、ectrical equipment Part 1: General requirements for safety, including Amendment 1:1991 and Amendment 2:1995Approved as an American National Standard with deviations by ASTM InternationalANSI/ISO 5356-1:2004(E) 2 ASTM International 3 Terms and definitions For the purposes of this document, the terms

33、and definitions given in ISO 4135 and the following apply. 3.1 22 mm latching connector female connector for engagement with a male conical connector of 22 mm size complying with this part of ISO 5356, and which has a feature to reduce the possibility of accidental disconnection 4 Conical connectors

34、 made of metal 4.1 General requirements The dimensions of conical connectors made of metal, including those made of composite materials in which the mating surfaces are metal, shall be as shown in Figures 1 and 2 and Table 1. NOTE See Annex E for dimensions of plug and ring gauges for the connectors

35、. 4.2 Additional requirements for male conical connectors of 22 mm size 4.2.1 Male conical connectors of 22 mm size, with the exception of those intended for connection to a face mask, shall incorporate the recess as shown in Figure 2 a). 4.2.2 Male conical connectors of 22 mm size to which it is in

36、tended to attach a face mask shall incorporate a shoulder or equivalent construction as shown in Figure 2 b). 4.2.3 If a circumferential groove or grooves are incorporated in the surface of a male conical connector of 22 mm size, the total width of the groove or grooves at the surface shall not exce

37、ed 8 mm. The radius on the entrance to the female connector and on the leading edge of the male cone should be not less than 0,5 mm and not more than 0,8 mm. Figure 1 Conical connectors made of metal Approved as an American National Standard with deviations by ASTM InternationalANSI/ISO 5356-1:2004(

38、E) ASTM International 3Table 1 Conical connectors made of metal Dimensions (see Figure 1)Taper lengthmin.Clearance to shoulder (if present)Length to tapermin.Taper ratioConnectorsize ABC D E Fmm mm mm mm mm mm 8,5 8,45 r 0,04 6 6,4 8,9 min. 8 1:19 15 15,47 r 0,04 10 16 16 min. 14,5 1:40 22 22,37 r 0

39、,04 15 21 See Figure 2 See Figure 2 1:40 23 23,175 r 0,02 13 18 18 min. 15 1:36 30 30,9 r 0,05 14 18 18 min. 14 1:20 Dimensions in millimetres a) Connector intended for breathing attachment (with recess) b) Connector intended for face mask (with shoulder) Circumferential grooves may be incorporated

40、on the surface of the male cone, if required (see 4.2.3). Approved as an American National Standard with deviations by ASTM InternationalANSI/ISO 5356-1:2004(E) 4 ASTM International Figure 2 Conical connectors of 22 mm size made of metal Supplementary dimensions 4.3 Additional requirements for conic

41、al connectors of 8,5 mm size The male conical connector shall have a minimum inside diameter of 6 mm extending inward for at least 6 mm from the end of the connector. 5 Conical connectors made of materials other than metal 5.1 General requirements Conical connectors made of materials other than meta

42、l shall meet the following requirements when they are type-tested with gauges having dimensions as shown in Figure A.1 and Table A.1. a) Conical connectors made of materials other than metal shall meet the dimensional requirements in Figure 1 and Table 1, with the exception than dimensions A and B a

43、nd ratio F may vary from those shown. b) When the connector is engaged in the appropriate plug or ring test gauge shown in Figure A.1 and Table A.1, by applying an axial force of (35 r 3,5) N for 8,5 mm and 15 mm connectors and (50 r 5) N for 22 mm and 30 mm connectors and, while maintaining the sam

44、e force, rotating the connector up to 20, its leading edge shall lie between the minimum and maximum diameter steps of the gauge. The connectors and gauges shall be maintained at a temperature of (20 r 3) C during the test. NOTE Because connectors made from plastics materials, for example polyamide,

45、 polyacetal, polycarbonate, polysulfone, etc., can vary greatly in their physical characteristics, it is not considered practicable to specify their dimensions; for this reason, gauging requirements have been included. It is also considered impracticable to generalize on matters such as cold flow an

46、d thermal instability, as well as possible changes in physical characteristics, contact with solvents, etc. It is the responsibility of the manufacturer to ensure that adequate tests have been carried out to prove as far as possible that the particular materials chosen for the connectors are suitabl

47、e. 5.2 Additional requirements for conical connectors of 22 mm size The requirements given in 4.2 apply. 5.3 Additional requirements for conical connectors of 8,5 mm size The requirements given in 4.3 apply. 6 22 mm latching connectors 6.1 22 mm latching connectors shall engage with the 22 mm male c

48、onnector with a recess as specified in Figure 2 a). 6.2 When tested in accordance with Annex B, the engaged connection shall not become disconnected. 6.3 When tested in accordance with Annex C, the leakage rate from the engaged connectors shall not exceed 5 ml/min (corrected to 20 C and 101,3 kPa).

49、Approved as an American National Standard with deviations by ASTM InternationalANSI/ISO 5356-1:2004(E) ASTM International 56.4 After being subjected to the procedure described in Annex D, the 22 mm latching connector shall still meet the requirements in 6.1, 6.2 and 6.3. 6.5 22 mm latching connectors intended for re-use shall meet the requirements in 6.1, 6.2, 6.3 and 6.4 after being subjected to the cleaning,