1、March 2013Translation by DIN-Sprachendienst.English price group 7No 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 11
2、.040.10!$0“1961395www.din.deDDIN EN ISO 5356-2Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2012);English version EN ISO 5356-2:2012,English translation of DIN EN ISO 5356-2:2013-03Ansthesie- und Beatmungsgerte Konische Konnekto
3、ren Teil 2: Gewichtstragende Konnektoren mit Schraubgewinde (ISO 5356-2:2012);Englische Fassung EN ISO 5356-2:2012,Englische bersetzung von DIN EN ISO 5356-2:2013-03Matriel danesthsie et de ranimation respiratoire Raccords coniques Partie 2: Raccords vis pouvant supporter un certain poids (ISO 5356-
4、2:2012);Version anglaise EN ISO 5356-2:2012,Traduction anglaise de DIN EN ISO 5356-2:2013-03SupersedesDIN EN ISO 5356-2:2007-10www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 11 pages02.13 DIN EN ISO 5356-2:2013-03 2 A comma is used as
5、the decimal marker. National foreword This document (EN ISO 5356-2:2012) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI
6、, United Kingdom). The responsible German body involved in its preparation was the Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Working Committee NA 053-03-01 AA Ansthesie und Beatmung. DIN EN ISO 5356 consists of the following parts, under the g
7、eneral title Anaesthetic and respiratory equip-ment 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 262 DIN ISO 262 ISO 965-2 DIN ISO 965-2 I
8、SO 4135:2001 DIN EN ISO 4135:2002-03 ISO 5356-1 DIN EN ISO 5356-1 Amendments This standard differs from DIN EN ISO 5356-2:2007-10 as follows: a) the scope has been editorially revised; b) Annex ZA “Relationship between this International Standard and the Essential Requirements of EU Directive (93/42
9、/EEC Medical devices)” has been deleted; c) the standard has been editorially revised. Previous editions DIN ISO 5356-2: 1991-04 DIN EN 1281-2: 1996-01 DIN EN ISO 5356-2: 2007-10 National Annex NA(informative) Bibliography DIN EN ISO 4135:2002-03, Anaesthetic and respiratory equipment Vocabulary DIN
10、 EN ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets DIN ISO 262, ISO general purpose metric screw threads Selected sizes for screws, bolts and nuts DIN ISO 965-2, ISO general purpose metric screw threads Tolerances Part 2: Limits of sizes for general pu
11、rpose external and internal screw threads Medium quality EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5356-2 November 2012 ICS 11.040.10 Supersedes EN ISO 5356-2:2007English Version Anaesthetic and respiratory equipment - Conical connectors - Part2:Screw-threadedweight-bearingconnectorsM
12、atriel danesthsie et de ranimation respiratoire - Raccords coniques - Partie 2: Raccords vis pouvant supporter un certain poids (ISO 5356-2:2012) Ansthesie- und Beatmungsgerte - Konische Konnektoren - Teil 2: Gewichtstragende Konnektoren mit Schraubgewinde (ISO 5356-2:2012) This European Standard wa
13、s approved by CEN on 14 November 2012. 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-date lists and bibliographical references concerning such
14、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 translation under the responsibility of a CEN member into its own l
15、anguage 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, Former Yugoslav Republic of Macedonia, France, Germany, Gre
16、ece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form
17、 and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 5356-2:2012: EEUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG (ISO 5356-2:2012) Contents Page Foreword . 3 Introduction . 4 1 Scope . 5 2 Normative references. 5 3 Term
18、s and definitions 5 4 Design . 6 Bibliography 9 2DIN EN ISO 5356-2:2013-03 EN ISO 5356-2:2012 (E) Foreword This document (EN ISO 5356-2:2012) has been prepared by Technical Committee ISO/TC 121 Anaesthetic and respiratory equipment in collaboration with Technical Committee CEN/TC 215 “Respiratory an
19、d 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 May 2013, and conflicting national standards shall be withdrawn at the latest by N
20、ovember 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 document supersedes EN ISO 5356-2:2007. According to the CEN/CENELE
21、C Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Icel
22、and, 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 5356-2:2012 has been approved by CEN as a EN ISO 5356-2:2012 without any modifi
23、cation. “”3DIN EN ISO 5356-2:2013-03 EN ISO 5356-2:2012 (E) IntroductionWhereas the conical connectors specified in ISO 5356-1 are satisfactory for lightweight breathing attachments, there is also a need for more substantial connectors to support heavy or fragile components. Factors governing the de
24、sign of these connectors include robustness, simplicity, ease of sterilization and ease of engagement and disengagement by hand. They should also be compatible with connectors meeting the requirements specified in ISO 5356-1 and should, if possible, eliminate the likelihood of inadvertent misconnect
25、ion, although it has to remain the responsibility of the user to check that any system in which they are used is correctly assembled before use.Screw-threaded weight-bearing connectors specified in this part of ISO 5356 can be used for attachments within the breathing system and at the common gas ou
26、tlet.4DIN EN ISO 5356-2:2013-03 EN ISO 5356-2:2012 (E) 1 ScopeThis part of ISO 5356 specifies dimensional requirements for screw-threaded weight-bearing conical connectors intended for use with inhalation anaesthesia apparatus and ventilators. Such connectors are intended for mounting heavy accessor
27、ies.This part of ISO 5356 specifies requirements for the following screw-threaded, weight-bearing conical connectors: 22 mm connectors; 22 mm/15 mm coaxial connectors.Requirements for the application of screw-threaded, weight-bearing conical connectors are not included in this part of ISO 5356, but
28、are or will be given in the relevant International Standards for specific medical devices and accessories.NOTE Requirements on cones and sockets are specified in ISO 5356-1.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated refe
29、rences, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 965-2, ISO general purpose metric screw threads Tolerances Part 2: Limits of sizes for general purpose external and internal screw threads Medium quali
30、tyISO 5356-1:1), Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1inhalation anaesthesia apparatusequipment intended for dispensing and delivering anaesthetic gases
31、 and vapours into a breathing system for delivery to the patient3.2breathing attachmentcomponent(s) intended to make up or complete a breathing systemNOTE Adapted from ISO 4135:2001, definition 4.1.6.1) To be published (Revision of ISO 5356-1:2004)5DIN EN ISO 5356-2:2013-03 EN ISO 5356-2:2012 (E) 3.
32、3breathing systemthose gas pathways continuously or intermittently in communication with the patients respiratory tract during any form of ventilationNOTE 1 In practice, a breathing system usually extends froma) the point of supply of a controlled gas mixture, e.g. the common gas outlet of an anaest
33、hetic machine (in some situations, particularly in lung ventilators, the point of supply may be inside a piece of equipment and should not be confused with a connection port fitted elsewhere, for example on the casing of a ventilator), orb) the fresh-gas inlet of a circle system, lung ventilator, T-
34、piece, etc., orc) the fresh-gas inlet of a manually operated resuscitator.NOTE 2 It usually extends to the point at which the gas mixture escapes into the atmosphere or a gas scavenging system, for example from an APL valve, the open end of a T-piece, etc.NOTE 3 Gas pathways exclusively concerned wi
35、th gas scavenging systems are not regarded as part of the breathing system.NOTE 4 Adapted from ISO 4135:2001, definition 4.1.1. 4 DesignThe dimensions of the components of screw-threaded weight-bearing connectors shall be as shown in Figure 1.The free axial movement of the union nut on the female co
36、mponent shall be not more than 2 mm in order that, when the connectors are unscrewed, the male and female components shall be forced apart.All male screw threads shall be M33 2, 6g, and all female screw threads shall be M33 2, 6H, in accordance with ISO 965-2.Dimensions in millimetresa) Male compone
37、nt6DIN EN ISO 5356-2:2013-03 EN ISO 5356-2:2012 (E) b) Female component Parallel socket (only essential dimensions shown)ac) Female component Taper and socket (only essential dimensions shown)ad) Union nut (only essential dimensions shown)b7DIN EN ISO 5356-2:2013-03 EN ISO 5356-2:2012 (E) e) Typical
38、 female component assemblybKey1 male 22 mm cone or 22 mm/15 mm coaxial as specified in ISO 5356-1 male 22 mm cone as specified in Figure 2 a) of ISO 5356-1:2 male screw thread3 O-ring groove recommended size 24,8 mm diameter (2,3 + 0,2/0) mm width to suit an O-ring of recommended size 22,1 mm intern
39、al diameter and 1,6 mm cross-section4 22 mm female conical socket as specified in ISO 5356-15 knurling6 female screw thread7 position of retaining lug, shoulder or circlip8 retaining shouldera18 mm diameter intended for use within breathing systems.bThe union nut may be retained by a circlip in plac
40、e of a shoulder.Figure 1 Components for screw-threaded, weight-bearing connectors8DIN EN ISO 5356-2:2013-03 EN ISO 5356-2:2012 (E) Bibliography1 ISO 262, ISO general-purpose metric screw threads Selected sizes for screws, bolts and nuts2 ISO 4135:2001, Anaesthetic and respiratory equipment Vocabulary9DIN EN ISO 5356-2:2013-03 EN ISO 5356-2:2012 (E)
