DIN EN ISO 5360-2016 Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360 2016) German version EN ISO 5360 2016《麻醉蒸发器 专用试剂灌充装置(ISO 5360-2016) 德文版本EN ISO 5360-2016》.pdf

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1、July 2016 English price group 14No 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 11.040.10!%XN(“2534305www.din.deDIN

2、 EN ISO 5360Anaesthetic vaporizers Agent-specific filling systems (ISO 5360:2016);English version EN ISO 5360:2016,English translation of DIN EN ISO 5360:2016-07Ansthesiemittelverdampfer Substanzspezifische Fllsysteme (ISO 5360:2016);Englische Fassung EN ISO 5360:2016,Englische bersetzung von DIN EN

3、 ISO 5360:2016-07vaporateurs danesthsie Systmes de remplissage spcifiques lagent (ISO 5360:2016);Version anglaise EN ISO 5360:2016,Traduction anglaise de DIN EN ISO 5360:2016-07SupersedesDIN EN ISO 5360:2012-04See start of applicationwww.beuth.deDocument comprises 31 pagesDTranslation by DIN-Sprache

4、ndienst.In case of doubt, the German-language original shall be considered authoritative.06.16 DIN EN ISO 5360:2016-07 2 A comma is used as the decimal marker. Start of application The start of application of this standard is 2016-07-01. For DIN EN ISO 5360:2012-04 there is a transition period endin

5、g on 31 March 2019. National foreword This document (EN ISO 5360:2016) 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 DIN-Normenausschuss Rettungsdienst und Krankenhaus (DIN Standards Committee Rescue Services and Hospital), Working Committee NA 053-03-01 AA Ansthesie und Beatmung. This standard contains specifications giving detail to the

7、 essential requirements set out in EU Directive 93/42/EEC on medical devices. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1101 DIN EN ISO 1101 IEC 62366-1 DIN EN 62366-1 (VDE 0750-241-1) Amendments This standard differs from DIN EN

8、ISO 5360:2012-04 as follows: a) in Figure 5 showing the configuration and dimensions of agent-specific male adaptors for use with isoflurane and sevoflurane, the presentation of dimension (9,1+0,20) mm has been amended; b) the informative Annex ZA “Relationship between this European Standard and the

9、 Essential Requirements of EU Directive (93/42/EEC on medical devices)” has been revised; c) the standard has been editorially revised. Previous editions DIN 13252: 1984-06 DIN EN 1280-1: 1997-09, 2000-08 DIN EN ISO 5360: 2008-03, 2009-08, 2012-04 DIN EN ISO 5360:2016-07 3 National Annex NA (informa

10、tive) Bibliography DIN EN 62366-1 (VDE 0750-241-1), Medical devices Part 1: Application of usability engineering to medical devices DIN EN ISO 1101, Geometrical Product Specifications (GPS) Geometrical tolerancing Tolerances of form, orientation, location and run-out DIN EN ISO 5360:2016-07 4 This p

11、age is intentionally blank EUROPEAN 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(ISO 5360:2016) vaporateurs danesthsie - Systmes de remplissage spcifiques lagent (ISO 5

12、360:2016) 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 Regulations which stipulate the conditions for giving this European Standard the status of

13、 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)

14、. 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, C

15、yprus, 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

16、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 any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO

17、 5360:2016 EForeword 61 Scope . 72 Normative references 73 Terms and definitions . 74 Bottle 85 Bottle collar . 96 Bottle adaptor 127 Filler receptacle 168 Filling rate 189 Leakage2010 Overfilling protection .2011 Colour coding 2012 Usability 2013 Clinical evaluation .2014 Information provided by th

18、e manufacturer .2114.1 Marking 2114.2 Labelling 2114.3 Instructions for use 21Annex A (informative) Recommendations on materials .23Annex B (informative) Types of agent-specific filling systems .24Annex C (normative) Determination of total leakage into atmosphere of anaesthetic agent during filling

19、25Bibliography .27Contents PageEuropean foreword 3 Annex ZA Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices 4 DIN EN ISO 5360:2016-07 EN ISO 5360:2016 (E)2.(informative)European foreword This document (EN ISO 5360:2016) has been

20、 prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboration 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 b

21、y publication of an identical text or by endorsement, at the latest by September 2016, and conflicting 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 C

22、ENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes 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 Di

23、rective(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 Standard: Austria, Belgium,

24、 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, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerlan

25、d, Turkey and the United Kingdom. Endorsement notice The text of ISO 5360:2016 has been approved by CEN as EN ISO 5360:2016 without any modification. DIN EN ISO 5360:2016-07 EN ISO 5360:2016 (E)3 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU

26、Directive 93/42/EEC on medical devices This European standard has been 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. Once this standard is ci

27、ted in the Official Journal of the European Union 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

28、with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.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 remark

29、s/notes 4, 5, 6, 7, 9, 10 7.5, first paragraph, first sentence 14.3 f), 14.2.1 last paragraph 7.5, second 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 Clause

30、s 4 to 7 of this standard specify the design of the filling system to ensure specificity for anaesthetic 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 syst

31、ems Information on restrictions on use is addressed in the clauses on labelling and instructions for use, 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

32、) 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 conformity 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) DIN EN ISO 5360:2016-07 EN ISO 5360:2016 (E)4 14.2.1 e) 13.3 f) Consistency across the C

33、ommunity 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 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

34、 the scope of this standard. DIN EN ISO 5360:2016-07 EN ISO 5360:2016 (E)5 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 te

35、chnical 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 close

36、ly with the International Electrotechnical 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 ne

37、eded for the different types of 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

38、 rights. ISO shall not be held 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

39、 this document is information given 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 Barrier

40、s to Trade (TBT) see the following 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

41、(ISO 5360:2012), of which it constitutes a minor revision with the following changes: Figure 5 has been technically revised; minor editorial modifications have been incorporated into the text.DIN EN ISO 5360:2016-07 EN ISO 5360:2016 (E)6 1 ScopeThis International Standard specifies requirements, inc

42、luding 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 unique properties of desflurane, dimensions for this agent have not

43、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 referencesThe following documents, in whole or in part, are normatively r

44、eferenced 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 1101, Geometrical Product Specifications (GPS) Geometrical toleranc

45、ing 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 dimensions, which are specific for a prescribed liquid anaesthetic agent

46、3.2agent-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) with collar, bottle connector (3.6), male adaptor (3.9), and fil

47、ler 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 adaptorassembly that is intended to connect a bottle for liquid anae

48、sthetic 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)DIN EN ISO 5360:2016-07 EN ISO 5360:2016 (E)7 3.6bottle connectoragent-specific (3.1) component that fits the thread on the bottle neck (3.7) and mates with the agent-speci