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1、BRITISH STANDARD BS EN ISO 5360:2007 Anaesthetic vaporizers Agent-specific filling systems The European Standard EN ISO 5360:2007 has the status of a British Standard ICS 11.040.10 ? Licensed Copy: London South Bank University, London South Bank University, Fri Feb 15 05:45:42 GMT+00:00 2008, Uncont
2、rolled Copy, (c) BSI BS EN ISO 5360:2007 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2008 BSI 2008 ISBN 978 0 580 59003 0 National foreword This British Standard is the UK implementation of EN ISO 5360:2007. It supersedes BS EN
3、 1280-1:1997 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/121, Anaesthetic and respiratory equipment. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include
4、 all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments/corrigenda issued since publication DateComments Licensed Copy: London South Bank University, London South Bank
5、 University, Fri Feb 15 05:45:42 GMT+00:00 2008, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5360 December 2007 ICS 11.040.10Supersedes EN 1280-1:1997 English Version Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006) Evaporateurs danesths
6、ie - Systmes de remplissage spcifiques lagent (ISO 5360:2006) Ansthesiemittelverdampfer - Substanzspezifische Fllsysteme (ISO 5360:2006) This European Standard was approved by CEN on 19 November 2007. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the condi
7、tions 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 European Standard exists in thre
8、e 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 the national standards bodies of A
9、ustria, 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, Switzerland and United Kingdom. EUROPEAN C
10、OMMITTEE 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 ISO 5360:2007: E Licensed Copy: L
11、ondon South Bank University, London South Bank University, Fri Feb 15 05:45:42 GMT+00:00 2008, Uncontrolled Copy, (c) BSI Foreword The text of ISO 5360:2006 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardizati
12、on (ISO) and has been taken over as EN ISO 5360:2007 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 publication of an identical text or by endorseme
13、nt, at the latest by June 2008, and conflicting national standards shall be withdrawn at the latest by June 2008. This document supersedes EN 1280-1:1997. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports ess
14、ential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European
15、 Standard: 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, Switzerland and the United Kin
16、gdom. Endorsement notice The text of ISO 5360:2006 has been approved by CEN as EN ISO 5360:2007 without any modifications. BS EN ISO 5360:2007 Licensed Copy: London South Bank University, London South Bank University, Fri Feb 15 05:45:42 GMT+00:00 2008, Uncontrolled Copy, (c) BSI Reference number IS
17、O 5360:2006(E) INTERNATIONAL STANDARD ISO 5360 Second edition 2006-10-01 Anaesthetic vaporizers Agent-specific filling systems vaporateurs danesthsie Systmes de remplissage spcifiques lagent BS EN ISO 5360:2007 Licensed Copy: London South Bank University, London South Bank University, Fri Feb 15 05:
18、45:42 GMT+00:00 2008, Uncontrolled Copy, (c) BSI ii Licensed Copy: London South Bank University, London South Bank University, Fri Feb 15 05:45:42 GMT+00:00 2008, Uncontrolled Copy, (c) BSI iii Contents Page Foreword iv 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 1 4 Bottle 2 5 Bo
19、ttle collar . 4 6 Bottle adaptor 8 7 Filler receptacle. 12 8 Filling rate 14 9 Leakage 16 10 Overfilling protection 16 11 Colour coding 16 12 Information provided by the manufacturer 16 Annex A (informative) Types of agent-specific filling systems. 18 Annex B (normative) Determination of total leaka
20、ge into atmosphere of anaesthetic agent during filling. 19 Bibliography. 21 BS EN ISO 5360:2007 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Medical Devices 22 Licensed Copy: London South Bank University, London South Ban
21、k University, Fri Feb 15 05:45:42 GMT+00:00 2008, Uncontrolled Copy, (c) BSI iv Foreword ISO (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
22、ISO technical committees. Each member body interested in a subject for which a technical committee 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
23、 closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical 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.
24、 Draft International Standards adopted by the technical committees are circulated to the member 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
25、document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 5360 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines. This secon
26、d edition cancels and replaces the first edition (ISO 5360:1993) which has been technically revised by virtue of incorporation of Technical Corrigendum 1:1998, inclusion of the changes presented and approved for ISO 5360:1993/Amd 1 (not published) and the need to update cross-references and other fa
27、ctual matters due to the passage of time. BS EN ISO 5360:2007 Licensed Copy: London South Bank University, London South Bank University, Fri Feb 15 05:45:42 GMT+00:00 2008, Uncontrolled Copy, (c) BSI 1 Anaesthetic vaporizers Agent-specific filling systems 1 Scope This International Standard specifie
28、s the dimensions of agent-specific filling systems for agent-specific anaesthetic vaporizers. This International Standard does not specify construction materials. Materials used for the parts of filling systems which come into contact with liquid anaesthetic agent should be selected with regard to:
29、a) toxicity; b) compatibility with anaesthetic agents; c) minimization of health risks due to substances leached from the materials. Because of the unique properties of desflurane, dimensions for this agent have not been specified in this International Standard. NOTE Designs of connection systems ar
30、e encouraged which only permit engagement of the agent-specific bottle adaptor to the bottle when the bottle collar is in place. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For
31、 undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1101:2004, Geometrical Product Specifications (GPS) Geometrical tolerancing Tolerances of form, orientation, location and run-out 3 Terms and definitions For the purposes of this document, the
32、following terms and definitions apply. 3.1 agent-specific having both a prescribed configuration and prescribed dimensions, which are specific for a prescribed liquid anaesthetic agent 3.2 agent-specific filling system functional system of agent-specific coded connections between an anaesthetic bott
33、le and an agent-specific anaesthetic vaporizer, consisting of, for example, a threaded bottle neck with collar, bottle connector, male adaptor and filler receptacle NOTE Different types of agent-specific filling systems are shown in Annex A. BS EN ISO 5360:2007 Licensed Copy: London South Bank Unive
34、rsity, London South Bank University, Fri Feb 15 05:45:42 GMT+00:00 2008, Uncontrolled Copy, (c) BSI 2 3.3 anaesthetic vaporizer device designed to facilitate the change of an anaesthetic agent from a liquid to a vapour 3.4 bottle adaptor assembly that is intended to connect a bottle for liquid anaes
35、thetic agent to an agent-specific anaesthetic vaporizer 3.5 bottle collar agent-specific component on the neck of a bottle causing it to be agent-specific 3.6 bottle connector agent-specific component that fits the thread on the bottle neck and mates with the agent-specific bottle collar 3.7 bottle
36、neck external threaded part of the bottle and the adjacent contour over which an agent-specific collar is fitted 3.8 filler receptacle receptacle for a bottle or a bottle adaptor on an agent-specific anaesthetic vaporizer 3.9 male adaptor part of a bottle adaptor that mates with a filler receptacle
37、on an agent-specific vaporizer 4 Bottle Each bottle shall have: a) the name of the anaesthetic agent, with which it is intended to be used, marked on it; b) either a bottle collar complying with Clause 5 and a threaded neck complying with Figure 1 and Table 1, or a permanently attached bottle adapto
38、r complying with 6.2. BS EN ISO 5360:2007 Licensed Copy: London South Bank University, London South Bank University, Fri Feb 15 05:45:42 GMT+00:00 2008, Uncontrolled Copy, (c) BSI 3 Dimensions in millimetres Key 1 optional pouring lip (not dimensioned) a Flatness and perpendicularity tolerances in a
39、ccordance with ISO 1101. NOTE The dimensions shown form part of this International Standard. Other features are for illustrative purposes only. See also Table 1. Figure 1 Two examples of threaded necks of bottles for anaesthetic agents Table 1 Dimensions of threaded necks of bottles for anaesthetic
40、agents (see also Figure 1) Bottle type Anaesthetic agent h1 0,3 mm h2 a min. mm s 0,45 mm min. at D1 p mm Thread turns min. D1 a nom. mm D2 b 0,3 mm D3 b 0,3 mm d max. mm. 1 Isoflurane Enflurane 9,75 23 1,2 2 35 30 3,2 1 28 23,6 21,5 28 2 Halothane 6,8 18,7 1,2 2 15 30 2,54 1,25 24 21,45 19,7 28 3 H
41、alothane (North America) 15 26,3 1 2 50 30 3,2 1,75 24 21,7 19,5 28 4 Spare 9,05 20 1,15 3 30 30 3,2 1,25 20 17,65 15,5 28 5 Spare 9,05 20 1,15 3 7 30 3,2 1,25 22 19,65 17,5 28 6 Methoxy- flurane 9,8 20 1,15 2 57 30 4,25 1,25 30 27,3 24,9 32 7 Spare 9,85 20 1,15 2 31 30 4,25 1,25 34 31,8 29,4 32 8 S
42、evoflurane 8,9 23,9 1,3 2 56 30 3,63 1,25 23,9 23,5 21,5 28 a Recommended values. b Summation of the tolerances of measures D2 and D3 shall be avoided. A maximum tolerance of 0,3 mm for (D2 D3) should be required to avoid problems with the fitting of any bottle connector. BS EN ISO 5360:2007 License
43、d Copy: London South Bank University, London South Bank University, Fri Feb 15 05:45:42 GMT+00:00 2008, Uncontrolled Copy, (c) BSI 4 5 Bottle collar 5.1 Bottle collars shall comply with the configuration and dimensions shown in Figure 2 and angle specified in Table 2 for the anaesthetic agent with w
44、hich it is intended to be used. 5.2 The position of the bottle collar relative to the screw thread of the bottle shall be as shown in Figure 3. 5.3 The bottle collar shall be attached to the bottle and shall be rotatable by hand. Dimensions in millimetres a) Bottle collar for small bottles, i.e. typ
45、es 1 to 5 and 8 BS EN ISO 5360:2007 Licensed Copy: London South Bank University, London South Bank University, Fri Feb 15 05:45:42 GMT+00:00 2008, Uncontrolled Copy, (c) BSI 5 Dimensions in millimetres b) Bottle collar for large bottles, i.e. types 6 and 7 A = Face A a See Table 2. b May vary to sui
46、t bottle. Figure 2 Configuration of agent-specific bottle collars BS EN ISO 5360:2007 Licensed Copy: London South Bank University, London South Bank University, Fri Feb 15 05:45:42 GMT+00:00 2008, Uncontrolled Copy, (c) BSI 6 Table 2 Dimensions and colours of agent-specific bottle collars and connec
47、tors Example of colour samples Anaesthetic agent a 0 30 Specified colour b Federal Standard 595:1994 colour BS 5252 colour Pantone colour SS 01 91 02: 2004 colour Munsell colour c DIN 6164 colour Halothane 20 Red 11 105 04 E 56 200 C NCS S 1080 R 5R4/14 8:7:2 Enflurane + 20 Orange 22 510 06 E 55 151
48、 C NCS S 0585-Y50R 2,5YR 6/16 5:5:1 Methoxy- flurane 0 Green 14 187 14 E 53 334 C NCS S 2060-B90G 10G 5/10 21:6:3 Desflurane N.S. d Blue n.a. e 18 E 53 3015 C NCS S 3060 B 10B 4/10 18:4:3 Not for agent identification White 37 875 18 B 15 5455 C NCS S 0502-B 10B 9/1 N:0:0.5 Not for agent identificati
49、on Black 15 042 00 E 53 Process black C NCS S 9000-N N 0,5 N:0:9 Sevoflurane + 50 Yellow n.a. e 10 E 53 108 C NCS S 0570-Y 6,25Y 8,5/12 2:6:1 Isoflurane 40 Purple n.a. e 24 E 53 254 C NCS S 3055-R50B 7,5P4/12 11:4:4 Spare Grey 16 251 00 A 09 Cool grey 9 C NCS S 5502 B 5PB 5/1 N:0:4 a Sign “+” means clockwise rotation and sign “” means anticlockwise rotation, when viewed from the top. b If a colour is used on a v