DIN EN ISO 5356-1-2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1 Cones and sockets (ISO 5356-1 2015) German version EN ISO 5356-1 2015《麻醉和呼吸设备 圆锥形接头 第1部分 .pdf

1、June 2015 Translation by DIN-Sprachendienst.English price group 12No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 1

2、1.040.10!%CI“2323827www.din.deDDIN EN ISO 5356-1Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets (ISO 5356-1:2015);English version EN ISO 5356-1:2015,English translation of DIN EN ISO 5356-1:2015-06Ansthesie- und Beatmungsgerte Konische Konnektoren Teil 1: Mnnliche

3、und weibliche Konen (ISO 5356-1:2015);Englische Fassung EN ISO 5356-1:2015,Englische bersetzung von DIN EN ISO 5356-1:2015-06Matriel danesthsie et de ranimation respiratoire Raccords coniques Partie 1: Raccords mles et femelles (ISO 5356-1:2015);Version anglaise EN ISO 5356-1:2015,Traduction anglais

4、e de DIN EN ISO 5356-1:2015-06SupersedesDIN EN ISO 5356-1:2004-09www.beuth.deDocument comprises 25 pagesIn case of doubt, the German-language original shall be considered authoritative.05.15DIN EN ISO 5356-1:2015-06 2 A comma is used as the decimal marker. National foreword This document (EN ISO 535

5、6-1:2015) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment”, Subcommittee SC 1 “Breathing attachments and anaesthetic machines” (Secretariat: DIN, Germany) in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretar

6、iat: BSI, United Kingdom). The responsible German body involved in its preparation was the DIN-Normenausschuss Rettungsdienst und Krankenhaus (DIN Standards Committee Rescue Services and Hospital), Working Committee NA 053-03-01 AA Ansthesie und Beatmung. DIN EN ISO 5356 consists of the following pa

7、rts, under the general title Anaesthetic and respiratory equipment Conical connectors: Part 1: Cones and sockets Part 2: Screw-threaded weight-bearing connectors The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 3040:2009 DIN EN ISO 3040:

8、2012-06 ISO 5356-2 DIN EN ISO 5356-2 ISO 5367:2014 DIN EN ISO 5367:2015-02 ISO 4135:2001 DIN EN ISO 4135:2002-03 Amendments This standard differs from DIN EN ISO 5356-1:2004-09 as follows: a) the definition of 22 mm latching connector has been deleted because the content is covered by the text of th

9、is part of ISO 5356; b) 11,5 mm cones and sockets have been included; c) the internal diameter for the 30 mm cone has been added and the internal diameter of the 8,5 mm cone has been changed from 6,0 mm to 6,25 mm; d) the requirement on reuse of 22 mm latching sockets and cones has been deleted beca

10、use this is covered by the standards for specific medical devices and accessories; e) specifications concerning recess and shoulder for the 22 mm cone have been revised; f) dimension D in Annex A for the plug and ring test gauges for 8,5 mm cones and sockets made of materials other than metal has be

11、en changed to (1,91 0,005) mm; g) the standard has been editorially revised. Previous editions DIN 13252: 1984-06 DIN ISO 5356-1: 1991-04 DIN EN 1281-1: 1997-03, 1998-07 DIN EN ISO 5356-1: 2004-09 DIN EN ISO 5356-1:2015-06 3 National Annex NA (informative) Bibliography DIN EN ISO 3040:2012-06, Geome

12、trical product specifications (GPS) Dimensioning and tolerancing Cones DIN EN ISO 4135:2002-03, Anaesthetic and respiratory equipment Vocabulary; Trilingual version EN ISO 4135:2001 DIN EN ISO 5356-2, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing conn

13、ectors DIN EN ISO 5367:2015-02, Anaesthetic and respiratory equipment Breathing sets and connectors DIN EN ISO 5356-1:2015-06 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5356-1 March 2015 ICS 11.040.10 Supersedes EN ISO 5356-1:2004English Version Anaes

14、thetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015) Matriel danesthsie et de ranimation respiratoire - Raccords coniques - Partie 1: Raccords mles et femelles (ISO 5356-1:2015) Ansthesie- und Beatmungsgerte - Konische Konnektoren - Teil 1: Mnnliche und

15、 weibliche Konen (ISO 5356-1:2015)This European Standard was approved by CEN on 10 January 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-

16、date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translati

17、on under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, F

18、ormer Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COM

19、IT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 5356-1:2015 EForeword 3Introduction 41 Scope . 52

20、Normative references 53 Dimensional requirements . 53.1 General requirements . 53.2 Additional requirements 74 22 mm latching sockets . 8Annex A (normative) Plug and ring test gauges for cones and sockets made of materials other than metal . 9Annex B (normative) Test for security of engagement of 22

21、 mm latching sockets to cones . 11Annex C (normative) Test for leakage from 22 mm latching sockets 12Annex D (normative) Drop procedure for 22 mm latching sockets 13Annex E (informative) Plug and ring test gauges for cones and sockets made of metal 14Annex F (informative) Suggested apparatus and met

22、hods for testing the security of engagement of 22 mm latching sockets .16Bibliography 21Contents Page2EN ISO 5356-1:2015 (E) IDIN EN ISO 5356-1:2015-06 Foreword This document (EN ISO 5356-1:2015) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment“ in collabora

23、tion with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI. 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 2015, and confli

24、cting national standards shall be withdrawn at the latest by September 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This docu

25、ment supersedes EN ISO 5356-1:2004. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugosla

26、v Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 5356-1:2015 has

27、been approved by CEN as EN ISO 5356-1:2015 without any modification. 3EN ISO 5356-1:2015 (E) IDIN EN ISO 5356-1:2015-06IntroductionIn clinical practice, several breathing attachments used in anaesthetic and respiratory equipment may have to be joined together to provide a suitable breathing system.

28、Items of medical equipment, such as a humidifier or a spirometer, are often incorporated into the breathing system which might also be connected to an anaesthetic gas scavenging system. Connections for these purposes are usually cone and socket joints, and a lack of standardization of these connecti

29、ons 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 cones and sockets used in anaesthetic and respiratory equipment.An important consideration is that conical connections n

30、eed to be secure but nevertheless disconnectable by the operator. The use of cones and sockets 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 disconnected, latching socke

31、ts can be used.Annex A includes a figure and a table detailing plug and ring test gauges that are used to check cones and sockets made of materials other than metal. Annex B, Annex C, and Annex D provide test methods for latching sockets, Annex E includes a figure and table detailing plug and ring t

32、est gauges that can be used to check metal cones and sockets, and Annex F contains recommendations for testing the security of latching sockets.Figure 1, detailing the dimensions and tolerances of cones and sockets, has been prepared in accordance with ISO 3040.In this document, the following print

33、types are used: requirements, compliance with which can be verified, and definitions: roman type; notes and examples: smaller roman type; test methods: italic type.4EN ISO 5356-1:2015 (E) IDIN EN ISO 5356-1:2015-06 1 ScopeThis part of ISO 5356 specifies dimensional and gauging requirements for cones

34、 and sockets intended for connecting anaesthetic and respiratory equipment, e.g. in breathing systems, anaesthetic gas scavenging systems, and vaporizers. The cones and sockets are therefore not regarded as devices in their own right.This part of ISO 5356 gives requirements for the following cones a

35、nd sockets: 8,5 mm and 11,5 mm sizes intended for use in neonatal and paediatric breathing systems; 15 mm and 22 mm sizes intended for general use in breathing systems; 22 mm latching sockets (including performance requirements); 23 mm size intended for use with vaporizers, but not for use in breath

36、ing systems; 30 mm size intended for the connection of a breathing system to an anaesthetic gas scavenging system.This part of ISO 5356 does not specify the medical devices and accessories on which these cones and sockets are to be provided.Requirements for the application of cones and sockets are n

37、ot included in this part of ISO 5356, but are or will be given in the relevant International Standards for specific medical devices and accessories.NOTE Requirements for screw-threaded weight-bearing connectors are specified in ISO 5356-2.2 Normative referencesThe following documents, in whole or in

38、 part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 5367:2014, Anaesthetic and respiratory equi

39、pment Breathing sets and connectors3 Dimensional requirements3.1 General requirements3.1.1 Cones and sockets made of metal shall comply with Figure 1 and the dimensions given in Table 1 as appropriate.Check compliance by functional testing.NOTE Annex E includes a figure and table detailing plug and

40、ring test gauges that can be used to check metal cones and sockets.5EN ISO 5356-1:2015 (E) IDIN EN ISO 5356-1:2015-063.1.2 Cones and sockets made of non-metallic materials shall comply with Figure 1 and the dimensions given in Table 1 except that the dimensions A and B and ratio F may vary from thos

41、e given in Table 1.Check compliance by engaging the cone or socket in the appropriate plug or ring test gauge according to Figure A.1 and Table A.1, by applying an axial force of (35 3,5) N for 8,5 mm, 11,5 mm, and 15 mm cones or sockets and (50 5) N for 22 mm and 30 mm cones or sockets while simult

42、aneously rotating the cone or socket (20 5). Its leading edge shall lie between the minimum and maximum diameter steps of the gauge. The cones or sockets and gauges shall be maintained at a temperature of (20 3) C during the test.NOTE Because cones or sockets made from plastics materials (for exampl

43、e polyamide, polyacetal, polycarbonate, polysulfone) can vary greatly in their physical characteristics, it is not considered practicable to specify dimensions A, B, and ratio F; for this reason, gauging requirements have been included. It is also considered impracticable to generalize on matters su

44、ch as cold flow and thermal instability, as well as possible changes in physical characteristics, contact with solvents, etc.BDECAGaHFFaFor the 8,5 mm cone and the 30 mm cone, dimension G over the minimum length, H, as specified in Table 1.NOTE The radius on the entrance to the socket and on the lea

45、ding edge of the cone is not intended to be less than 0,5 mm and not more than 0,8 mm.Figure 1 Interconnecting details of cones and sockets6EN ISO 5356-1:2015 (E) IDIN EN ISO 5356-1:2015-06 Table 1 Dimensions of cones and sockets (see Figure 1)Dimensions in millimetresConnector sizeTaper lengthClear

46、ance to shoulder (if present)Length to taperTaper ratioMinimum internal diameter of coneMinimum length of internal diameter of the cone (G)A B C D E F G H8,5 8,45 0,04 6 6,4 8,9 8 1:19 6,25 6,011,5 11,50 0,04 10 13,5 16 15 1:40 a a15 15,47 0,04 10 16 16 14,5 1:40 a a22 22,37 0,04 15 21 See Figure 3S

47、ee Figure 31:40 a a23 23,175 0,02 13 18 18 15 1:36 a a30 30,9 0,05 14 18 18 14 1:20 27,0 12,0a Not specified.3.2 Additional requirements3.2.1 22 mm cones designed to connect to a breathing tube complying with ISO 5367:2014, 5.3.2.2, or a latching socket (see Clause 4) shall incorporate a recess, the

48、 dimensions of which are given in Figure 2.Check compliance by functional testing.Dimensions in millimetresl 6JR0,4R0,4Keyl taper length: 19 5005,+J diameter of recess: 20005+ ,Figure 2 Details of recess for 22 mm cones3.2.2 22 mm cones, designed to connect to a face mask shall incorporate a means t

49、o prevent over insertion (e.g. shoulder) and comply with the dimensions given in Figure 3.Check compliance by functional testing.7EN ISO 5356-1:2015 (E) IDIN EN ISO 5356-1:2015-062621 0,5Figure 3 Dimensions of 22 mm cones designed to connect to a face mask4 22 mm latching sockets4.1 22 mm latching sockets shall be designed to engage with the recess of the 22 mm cone as specified in Figure 2.Check compliance by visual inspection.4.2 Engaged latching cones and sockets shal