EN ISO 5360-2016 en Anaesthetic vaporizers - Agent-specific filling systems《麻醉蒸发器专用试剂灌装系统(ISO 5360 2016)》.pdf

1、BSI Standards PublicationBS EN ISO 5360:2016Anaesthetic vaporizers Agent-specific filling systemsBS EN ISO 5360:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 5360:2016. It supersedes BS EN ISO 5360:2012 which is withdrawn.The UK participation in its p

2、reparation 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 all the necessary provisions of a contract. Users are responsib

3、le for its correct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016ISBN 978 0 580 89578 4 ICS 11.040.10 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standard

4、s Policy and Strategy Committee on 31 March 2016.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5360 March 2016 ICS 11.040.10 Supersedes EN ISO 5360:2012English Version Anaesthetic vaporizers - Agent-specific filling systems (I

5、SO 5360:2016) vaporateurs danesthsie - Systmes de remplissage spcifiques lagent (ISO 5360:2016) Ansthesiemittelverdampfer - Substanzspezifische Fllsysteme (ISO 5360:2016) This European Standard was approved by CEN on 7 November 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regu

6、lations 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-CENELEC Management Centre or to any CEN memb

7、er. 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 language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. C

8、EN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, 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,

9、 Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in

10、any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 5360:2016 EBS EN ISO 5360:2016EN ISO 5360:2016 (E) 3 European foreword This document (EN ISO 5360:2016) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboration

11、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 2016, and conflictin

12、g national standards shall be withdrawn at the latest by March 2019. 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 sup

13、ersedes EN ISO 5360:2012. This document has been prepared under a mandate given to CEN by the European Commission and the European 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 par

14、t of this document. 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 Yugoslav Republic of Ma

15、cedonia, 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 5360:2016 has been approved by C

16、EN as EN ISO 5360:2016 without any modification. BS EN ISO 5360:2016EN ISO 5360:2016 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices This European standard has been prepared under a mandate given to

17、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. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a nati

18、onal 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 of that Directive and associated EFTA regulations. Table ZA

19、.1 Correspondence between this European Standard and EU Directive 93/42/EEC Clause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/notes 4, 5, 6, 7, 9, 10 7.5, first paragraph, first sentence 14.3 f), 14.2.1 last paragraph 7.5, second

20、 paragraph Only the presence of phthalates is addressed; Presumption of conformity to labelling requirement only provided if the symbol defined in EN 15896 is used 4, 5, 6, 7, 9 and 11 9.1 Clauses 4 to 7 of this standard specify the design of the filling system to ensure specificity for anaesthetic

21、agent and avoid the anaesthetic agent escaping into environment. Standard specifies colour coding of the anaesthetic agents including their generic names for a safe connection to anaesthetic systems Information on restrictions on use is addressed in the clauses on labelling and instructions for use,

22、 see 14.1 c), 14.2.1 c), d), e), f), 14.2.2, 14.3 a) d) and f). 14 13.1 11 13.2 Standard specifies colour coding of the anaesthetic agents including their generic names. 14.1 a), 14.2.1 a) 13.3 a) 11, 14.1 c), 14.2.1 b), 14.2.1 c) 13.3 b) packaging is not addressed 14.1 b) 13.3 d) Presumption of con

23、formity to ER 13.3 d) only provided if the word “LOT” is used 14.2.1.d) 13.3 e) 14.1 a), 14.2.1 a) 13.3 a) BS EN ISO 5360:2016EN ISO 5360:2016 (E) 5 14.2.1 e) 13.3 f) Consistency across the Community is not addressed 14.2.1 f) 13.3 i) 14.1 c), 14.2.1 c), 14.2.2, 13.3 j) 14.2.2), 14.3 b) 13.3 k) 14.1

24、 b) 13.5 14.3 a), 14.3 b) 13.6 a) 14.3 c), 14.3 d) 13.6 d) 14.3 g 13.6 h) 14.3 h) 13.6 q) WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 5360:2016ISO 5360:2016(E)Foreword iv1 Scope . 12 Normative references

25、13 Terms and definitions . 14 Bottle 25 Bottle collar . 36 Bottle adaptor . 67 Filler receptacle 108 Filling rate 129 Leakage1410 Overfilling protection .1411 Colour coding 1412 Usability 1413 Clinical evaluation .1414 Information provided by the manufacturer .1514.1 Marking 1514.2 Labelling 1514.3

26、Instructions for use 15Annex A (informative) Recommendations on materials .17Annex B (informative) Types of agent-specific filling systems .18Annex C (normative) Determination of total leakage into atmosphere of anaesthetic agent during filling 19Bibliography .21 ISO 2016 All rights reserved iiiCont

27、ents PageBS EN ISO 5360:2016ISO 5360:2016(E)ForewordISO (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 ISO technical committees. Each member

28、 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 closely with the International Elect

29、rotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of

30、 ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).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

31、responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information g

32、iven for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the follow

33、ing URL: Foreword - Supplementary information.The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines.This fourth edition cancels and replaces the third edition (ISO 5360:2012), of which it co

34、nstitutes a minor revision with the following changes: Figure 5 has been technically revised; minor editorial modifications have been incorporated into the text.iv ISO 2016 All rights reservedBS EN ISO 5360:2016INTERNATIONAL STANDARD ISO 5360:2016(E)Anaesthetic vaporizers Agent-specific filling syst

35、ems1 ScopeThis International Standard specifies requirements, including dimensions, for agent-specific filling systems for agent-specific anaesthetic vaporizers.This International Standard does not specify construction materials.NOTE 1 For recommendations on materials, see Annex A.Because of the uni

36、que properties of desflurane, dimensions for this agent have not been specified in this International Standard.NOTE 2 Designs of connection systems, which only permit engagement of the agent-specific bottle adaptor to the bottle when the bottle collar is in place, are encouraged.2 Normative referenc

37、esThe following documents, in whole or in 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 11

38、01, Geometrical Product Specifications (GPS) Geometrical tolerancing Tolerances of form, orientation, location and run-out3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1agent-specifichaving both a prescribed configuration and prescribed dimensi

39、ons, which are specific for a prescribed liquid anaesthetic agent3.2agent-specific filling systemfunctional system of agent-specific (3.1) coded connections between an anaesthetic bottle and an agent-specific (3.1) anaesthetic vaporizer (3.3), consisting of, for example, a threaded bottle neck (3.7)

40、 with collar, bottle connector (3.6), male adaptor (3.9), and filler receptacle (3.8)Note 1 to entry: Different types of agent-specific filling systems are shown in Annex B.3.3anaesthetic vaporizerdevice designed to facilitate the change of an anaesthetic agent from a liquid to a vapour3.4bottle ada

41、ptorassembly that is intended to connect a bottle for liquid anaesthetic agent to an agent-specific (3.1) anaesthetic vaporizer (3.3)3.5bottle collaragent-specific (3.1) component on the neck of a bottle causing it to be agent-specific (3.1) ISO 2016 All rights reserved 1BS EN ISO 5360:2016ISO 5360:

42、2016(E)3.6bottle connectoragent-specific (3.1) component that fits the thread on the bottle neck (3.7) and mates with the agent-specific (3.1) bottle collar (3.5)3.7bottle neckexternal threaded part of the bottle and the adjacent contour over which an agent-specific (3.1) collar is fitted3.8filler r

43、eceptaclereceptacle for a bottle or a bottle adaptor (3.4) on an agent-specific (3.1) anaesthetic vaporizer (3.3)3.9male adaptorpart of a bottle adaptor (3.4) that mates with a filler receptacle (3.8) on an agent-specific (3.1) vaporizer4 BottleEach bottle shall have the following:a) name of the ana

44、esthetic 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 adaptor complying with 6.2.Dimensions in millimetresh1h20,75 D 1pdD 2D 3h1h2sD 1pD 3dD 20,75 s1

45、aa1a a0,25 0,2 0,25 0,2Key1 optional pouring lip (dimension not specified)aFlatness and perpendicularity tolerances in accordance with ISO 1101.NOTE The dimensions shown form part of this International Standard. Other features are for illustrative purposes only. See Table 1.Figure 1 Two examples of

46、threaded necks of bottles for anaesthetic agents2 ISO 2016 All rights reservedBS EN ISO 5360:2016ISO 5360:2016(E)Table 1 Dimensions of threaded necks of bottles for anaesthetic agentsBottle typeAnaesthetic agenth10,3 mmh2amin. mms 0,45 mm min. at D1p mmThread turns min.D1anom. mmD2b0,3 mmD3b0,3 mmd

47、max. mm1Isoflurane Enflurane9,75 23 1,2 2 35 30 3,2 1 28 23,6 21,5 282 Halothane 6,8 18,7 1,2 2 15 30 2,54 1,25 24 21,45 19,7 283Halothane (USA)15 26,3 1 2 50 30 3,2 1,75 24 21,7 19,5 284 Spare 9,05 20 1,15 3 30 30 3,2 1,25 20 17,65 15,5 285 Spare 9,05 20 1,15 3 7 30 3,2 1,25 22 19,65 17, 5 286Metho

48、xy- flurane9,8 20 1,15 2 57 30 4,25 1,25 30 27, 3 24,9 327 Spare 9,85 20 1,15 2 31 30 4,25 1,25 34 31,8 29,4 328 Sevoflurane 8,9 23,9 1,3 2 56 30 3,63 1,25 23,9 23,5 21,5 28NOTE See Figure 1.aRecommended values.bSummation of the tolerances of measures D2and D3shall be avoided. A maximum tolerance of

49、 0,3 mm for (D2 D3) should be required to avoid problems with the fitting of any bottle connector.5 Bottle collar5.1 Bottle collars shall comply with the configuration and dimensions shown in Figure 2 and angle, , specified in Table 2 for the anaesthetic agent with which 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 rotatabl