BS EN ISO 5356-1-2015 Anaesthetic and respiratory equipment Conical connectors Cones and sockets《麻醉和呼吸设备 圆锥形接头 锥体和锥套》.pdf

1、BSI Standards PublicationAnaesthetic and respiratory equipment Conical connectorsPart 1: Cones and sockets BS EN ISO 5356-1:2015National forewordThis British Standard is the UK implementation of EN ISO 5356-1:2015. Itsupersedes BS EN ISO 5356-1:2004 which is withdrawn.The UK participation in its pre

2、paration was entrusted by TechnicalCommittee CH/121, Anaesthetic and respiratory equipment, toSubcommittee CH/121/1, Breathing attachments and anaesthetic machines.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to in

3、clude all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 78182 7ICS 11.040.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This Br

4、itish Standard was published under the authority of theStandards Policy and Strategy Committee on 31 March 2015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 5356-1:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5356-1 March 2015 ICS 11.040.1

5、0 Supersedes EN ISO 5356-1:2004English Version Anaesthetic 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 Beatmung

6、sgerte - Konische Konnektoren - Teil 1: Mnnliche und 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 o

7、f a national standard without any alteration. Up-to-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

8、). A version in any other language made by translation 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,

9、Cyprus, Czech Republic, Denmark, Estonia, Finland, Former 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

10、 Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT 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 IS

11、O 5356-1:2015 EEN ISO 5356-1:2015 (E) 2 Contents Page Foreword .3 BS EN ISO 5356-1:2015EN ISO 5356-1:2015 (E) 3 Foreword This document (EN ISO 5356-1:2015) has been prepared by Technical Committee ISO/TC 121 “Anaestheticand respiratory equipment“ in collaboration with Technical Committee CEN/TC 215

12、“Respiratory andanaesthetic 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 identicaltext or by endorsement, at the latest by September 2015, and conflicting national standards shall bewithdrawn

13、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 patentrights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 5356-1:2004. According

14、 to the CEN-CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, CzechRepublic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greec

15、e,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 been approved by CEN as EN ISO 5356-1:2015 withou

16、t any modification. BS EN ISO 5356-1:2015ISO 5356-1:2015(E).Introduction v1 Scope . 12 Normative references 13 Dimensional requirements . 13.1 General requirements . 13.2 Additional requirements 34 22 mm latching sockets . 4Annex A (normative) Plug and ring test gauges for cones and sockets made of

17、materials other than metal . 5Annex B (normative) Test for security of engagement of 22 mm latching sockets to cones 7Annex C (normative) Test for leakage from 22 mm latching sockets . 8Annex D (normative) Drop procedure for 22 mm latching sockets . 9Annex E (informative) Plug and ring test gauges f

18、or cones and sockets made of metal 10Annex F (informative) Suggested apparatus and methods for testing the security of engagement of 22 mm latching sockets .12Bibliography .17 ISO 2015 All rights reserved iiiContents PageBS EN ISO 5356-1:2015ISO 5356-1:2015(E)IntroductionIn clinical practice, severa

19、l breathing attachments used in anaesthetic and respiratory equipment may have to be joined together to provide a suitable breathing system. 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 anaesthe

20、tic gas scavenging system. Connections for these purposes are usually cone and socket joints, and a lack of standardization of these connections has given rise to problems of interchangeability when connecting equipment made by different manufacturers. This part of ISO 5356 specifies the requirement

21、s and dimensions for cones and sockets used in anaesthetic and respiratory equipment.An important consideration is that conical connections need 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 neces

22、sarily prevent them being disconnected accidentally. To minimize the risk of 22 mm connectors being accidentally disconnected, latching sockets 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

23、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 test 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, detai

24、ling the dimensions and tolerances of cones and sockets, has been prepared in accordance with ISO 3040.In this document, the following print types are used: requirements, compliance with which can be verified, and definitions: roman type; notes and examples: smaller roman type; test methods: italic

25、type. ISO 2015 All rights reserved vBS EN ISO 5356-1:2015Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets1 ScopeThis part of ISO 5356 specifies dimensional and gauging requirements for cones and sockets intended for connecting anaesthetic and respiratory equipment,

26、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 and sockets: 8,5 mm and 11,5 mm sizes intended for use in neonatal and paedia

27、tric 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 breathing systems; 30 mm size intended for the connection of a breathing system to

28、 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 not included in this part of ISO 5356, but are or will be given in the releva

29、nt 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 part, are normatively referenced in this document and are indispensable for

30、 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 equipment Breathing sets and connectors3 Dimensional requirements3.1 General req

31、uirements3.1.1 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 ring test gauges that can be used to check metal cones and sockets.INTERNATI

32、ONAL STANDARD ISO 5356-1:2015(E) ISO 2015 All rights reserved 1BS EN ISO 5356-1:2015ISO 5356-1:2015(E)3.1.2 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 those given in Tabl

33、e 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 simultaneously rotati

34、ng 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 example polyamide, po

35、lyacetal, 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 such as cold flow

36、 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 leading edge of th

37、e 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 sockets2 ISO 2015 All rights reservedBS EN ISO 5356-1:2015ISO 5356-1:2015(E)Table 1 Dimensions of cones and sockets (see Figure 1)Dimensions in millimetresConnector sizeTaper lengthCl

38、earance 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

39、 3See 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,

40、the 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 mean

41、s to prevent over insertion (e.g. shoulder) and comply with the dimensions given in Figure 3.Check compliance by functional testing. ISO 2015 All rights reserved 3BS EN ISO 5356-1:2015ISO 5356-1:2015(E)2621 0,5Figure 3 Dimensions of 22 mm cones designed to connect to a face mask4 22 mm latching sock

42、ets4.1 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 shall not become disconnected when subjected to an axial separation force of (50 5) N for 10 s.Check compl

43、iance by the test method given in Annex B.4.3 Engaged latching cones and sockets shall not leak by more than 5 ml/min (corrected to 20 C and 101,3 kPa) when subjected to an internal pressure of (8 0,5) kPa.Check compliance by the test method given in Annex C.4.4 Engaged latching cones and sockets sh

44、all meet the requirements of 4.2 and 4.3 after being dropped from a height of 1 m.Check compliance by the test method given in Annex D.4 ISO 2015 All rights reservedBS EN ISO 5356-1:2015ISO 5356-1:2015(E)Annex A (normative) Plug and ring test gauges for cones and sockets made of materials other than

45、 metalFigure A.1 and Table A.1 give details of plug and ring gauges for use in checking cones and sockets made of materials other than metals.Dimensions in millimetresSurface roughness values in micrometresBDEACEDCttRz 0,4Rz 0,4R0,5R0,354R0,5R0,3515Fab25R0,5R0,353FR0,5R0,35abKey1 face A2 face B3 ste

46、p to check mating gauges ground flush to face A4 step to check mating gauges ground flush to face B5 basic stepsaPosition min.bPosition max.NOTE 1 Basic and mating gauge steps are optional.NOTE 2 Test gauges are usually made of metal.Figure A.1 Plug and ring test gauges for cones and sockets made of

47、 materials other than metal ISO 2015 All rights reserved 5BS EN ISO 5356-1:2015ISO 5356-1:2015(E)Table A.1 Plug and ring test gauges for cones and sockets made of materials other than metal Dimensions (see Figure A.1)Dimensions in millimetresConnector sizeA B C D E FTolerance on taper per unit of le

48、ngth on diameter8,5 8,50 0,005 8,09 0,005 8,4 0,005 1,91 0,005 See NOTE 1:19 0,053 0,000 211,5 11,525 0,005 11,165 0,005 15,5 0,005 4,3 0,005 2,2 0,005 1:40 0,025 0,000 215 15,525 0,005 15,165 0,005 14,5 0,005 4,3 0,005 2,2 0,005 1:40 0,025 0,000 222 22,425 0,005 21,94 0,005 19,5 0,005 5,2 0,005 2,2

49、 0,005 1:40 0,025 0,000 230 30,98 0,005 30,12 0,005 17,2 0,005 3,1 0,005 1,6 0,005 1:20 0,050 0,000 2NOTE Gauges for 8,5 mm cones and sockets have only one mating step.6 ISO 2015 All rights reservedBS EN ISO 5356-1:2015ISO 5356-1:2015(E)Annex B (normative) Test for security of engagement of 22 mm latching sockets to conesB.1 Condition a cone complying with Figure 2 and the latching socket for 1 h at a t