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1、BRITISH STANDARD BS EN ISO 5356-2:2007 Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectors The European Standard EN ISO 5356-2:2007 has the status of a British Standard ICS 11.040.10 ? Licensed Copy: London South Bank University, London South Ban
2、k University, Wed Oct 17 01:13:35 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN ISO 5356-2:2007 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2007 BSI 2007 ISBN 978 0 580 55817 7 National foreword This British Standard is the
3、UK implementation of EN ISO 5356-2:2007. It is identical to ISO 5356-2:2006. It supersedes BS EN 1281-2:1996 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/1, Breathing attachments
4、 and anaesthetic machines. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard
5、 cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments Licensed Copy: London South Bank University, London South Bank University, Wed Oct 17 01:13:35 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO
6、 5356-2 August 2007 ICS 11.040.10Supersedes EN 1281-2:1995 English Version Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356- 2:2006) Matriel danesthsie et de ranimation respiratoire - Raccords coniques - Partie 2: Raccords vis su
7、pportant un certain poids (ISO 5356-2:2006) Ansthesie- und Beatmungsgerte - Konische Konnektoren - Teil 2: Gewichtstragende Konnektoren mit Schraubgewinde (ISO 5356-2:2006) This European Standard was approved by CEN on 26 July 2007. CEN members are bound to comply with the CEN/CENELEC Internal Regul
8、ations 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 national standards may be obtained on application to the CEN Management Centre or to any CEN member. This
9、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 language and notified to the CEN Management Centre has the same status as the official versions. CEN members are th
10、e national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerlan
11、d and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2007 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN I
12、SO 5356-2:2007: E Licensed Copy: London South Bank University, London South Bank University, Wed Oct 17 01:13:35 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Foreword The text of ISO 5356-2:2006 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the Internat
13、ional Organization for Standardization (ISO) and has been taken over as EN ISO 5356-2:2007 by 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 publicatio
14、n of an identical text or by endorsement, at the latest by February 2008, and conflicting national standards shall be withdrawn at the latest by February 2008. This document supersedes EN 1281-2:1995. This document has been prepared under a mandate given to CEN by the European Commission and the Eur
15、opean Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. EN ISO 5356 consists of the following parts under the general title Anaesthetic and respiratory equipment
16、 Conical connectors. Part 1: Cones and sockets Part 2: Screw-threaded weight-bearing connectors; 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, Cyprus, Czech
17、 Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 5356-2:2006 has
18、 been approved by CEN as EN ISO 5356-2:2007 without any modifications. EN ISO 5356-2:2007 Licensed Copy: London South Bank University, London South Bank University, Wed Oct 17 01:13:35 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Reference number ISO 5356-2:2006(E) INTERNATIONAL STANDARD ISO 5356-2 Se
19、cond edition 2006-09-01 Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectors Matriel danesthsie et de ranimation respiratoire Raccords coniques Partie 2: Raccords vis supportant un certain poids EN ISO 5356-2:2007 Licensed Copy: London South Bank
20、University, London South Bank University, Wed Oct 17 01:13:35 GMT+00:00 2007, Uncontrolled Copy, (c) BSI ii Licensed Copy: London South Bank University, London South Bank University, Wed Oct 17 01:13:35 GMT+00:00 2007, Uncontrolled Copy, (c) BSI iii Foreword ISO (the International Organization for S
21、tandardization) 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 committee has been established has the ri
22、ght 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 electrotechnical standardization. Internationa
23、l 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 member bodies for voting. Publication as
24、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 identifying any or all such patent rights. ISO
25、 5356-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines. This second edition cancels and replaces the first edition (ISO 5356-2:1987) which has been technically revised. ISO 5356 consists of the
26、following parts, under the general title Anaesthetic and respiratory equipment Conical connectors: Part 1: Cones and sockets Part 2: Screw-threaded weight-bearing connectors EN ISO 5356-2:2007 Licensed Copy: London South Bank University, London South Bank University, Wed Oct 17 01:13:35 GMT+00:00 20
27、07, Uncontrolled Copy, (c) BSI iv Introduction Whereas 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 design of these connectors
28、include robustness, simplicity, ease of sterilization, and ease of engagement and disengagement by hand. They should also be compatible with connectors meeting the requirements laid down in ISO 5356-1 and should, if possible, eliminate the likelihood of inadvertent misconnection, although it has to
29、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 may be used for attachments within the breathing system and at the common gas outlet. EN ISO 5356-2:200
30、7 Licensed Copy: London South Bank University, London South Bank University, Wed Oct 17 01:13:35 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 1 Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectors 1 Scope This part of ISO 5356 specifies requirements
31、 for screw-threaded weight-bearing conical connectors intended for use with inhalation anaesthesia apparatus and ventilators; such connectors are intended for mounting heavy accessories. 2 Normative references The following referenced documents are indispensable for the application of this document.
32、 For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 965-2:1998, ISO general purpose metric screw threads Tolerances Part 2: Limits of sizes for general purpose external and internal screw
33、 threads Medium quality ISO 5356-1:2004, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 inhalation anaesthesia apparatus equipment intended for dispensing and
34、 delivering anaesthetic gases and vapours into a breathing system for delivery to the patient NOTE Adapted from ISO 4135:2001, definition 2.1.1. 3.2 breathing attachments components intended to make up or complete a breathing system NOTE Adapted from ISO 4135:2001, definition 4.1.6. EN ISO 5356-2:20
35、07 Licensed Copy: London South Bank University, London South Bank University, Wed Oct 17 01:13:35 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 2 3.3 breathing system those gas pathways continuously or intermittently in communication with the patients respiratory tract during any form of ventilation NO
36、TE 1 In practice a breathing system usually extends from a) the point of supply1) of a controlled gas mixture, e.g. the common gas outlet of an anaesthetic machine or b) the fresh-gas inlet of a circle system, lung ventilator, T-piece, etc. or c) the fresh-gas inlet of a manually-operated resuscitat
37、or. 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 with gas scavenging systems are not regarded as part of the breathing s
38、ystem. NOTE 4 Adapted from ISO 4135:2001, definition 4.1.1. 4 Design The 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 component shall be not more than 2 mm in order that, when the connec
39、tors are unscrewed, the male and female components shall be forced apart. All male screw threads shall be M33 2-6 g and all female screw threads shall be M33 2-6 H in accordance with ISO 965-2:1998. 1) In some situations, particularly in lung ventilators, this point may be inside a piece of equipmen
40、t and should not be confused with a connection port fitted elsewhere, for example on the casing of a ventilator. EN ISO 5356-2:2007 Licensed Copy: London South Bank University, London South Bank University, Wed Oct 17 01:13:35 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 3 Dimensions in millimetres a)
41、 Male component b) Female component Parallel socket (only essential dimensions shown) a c) Female component Taper and socket (only essential dimensions shown) a d) Union nut (only essential dimensions shown) e) Typical female component assembly Key 1 male 22 mm cone or 22 mm/15 mm coaxial as specifi
42、ed in ISO 5356-1:2004 2 male screw thread 3 O-ring groove recommended size 24,8 (2,3 + 0,2/0) wide to suit O-ring of recommended size 22,1 internal diameter and 1,6 cross-section 4 22 mm female conical socket as specified in ISO 5356-1:2004 5 knurled 6 female screw thread 7 position of retaining lug
43、, shoulder or circlip 8 retaining shoulder b a 18 mm diameter intended for use within breathing systems. b The union nut may be retained by a circlip in place of a shoulder. Figure 1 Components for screw-threaded, weight-bearing connectors EN ISO 5356-2:2007 Licensed Copy: London South Bank Universi
44、ty, London South Bank University, Wed Oct 17 01:13:35 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 4 Bibliography 1 ISO 262, ISO general-purpose metric screw threads Selected sizes for screws, bolts and nuts 2 ISO 4135:2001, Anaesthetic and respiratory equipment Vocabulary EN ISO 5356-2:2007 Licensed
45、Copy: London South Bank University, London South Bank University, Wed Oct 17 01:13:35 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive (93/42/EEC Medical devices) This European Standard has be
46、en prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC Medical devices. Once this standard is cited in the Official Journal of the European Communit
47、ies under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements
48、of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC Medical devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Remarks/Notes 4 1, 2, 3, 4, 9.1 WARNING Other requirements and ot
49、her EU Directives may be applicable to the product(s) falling within the scope of this standard. 5 EN ISO 5356-2:2007 Licensed Copy: London South Bank University, London South Bank University, Wed Oct 17 01:13:35 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN ISO 5356-2:2007 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing British S