EN ISO 5360-2012 4375 Anaesthetic vaporizers - Agent-specific filling systems《麻醉蒸发器 专用试剂灌充装置》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 5360:2012Anaesthetic vaporizers Agent-specific filling systems(ISO 5360:2012)Copyright European Committee for Standardization Provided by IHS under license with CENNot

2、for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 5360:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 5360:2012.It supersedes BS EN ISO 5360:2009 which is withdrawn.The UK participation in its preparation was entr

3、usted to TechnicalCommittee CH/121/1, Breathing attachments and anaestheticmachines.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its c

4、orrectapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 73789 3ICS 11.040.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strat

5、egy Committee on 30 November 2012.Amendments issued since publicationDate Text affectedCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARD NORME EUROPENNE EUROPISCH

6、E NORM EN ISO 5360 January 2012 ICS 11.040.10 Supersedes EN ISO 5360:2009English Version Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2012) vaporateurs danesthsie - Systmes de remplissage spcifiques lagent (ISO 5360:2012) Ansthesiemittelverdampfer - Substanzspezifische Fllsystem

7、e (ISO 5360:2012) This European Standard was approved by CEN on 14 January 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 b

8、ibliographical 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). A version in any other language made by translation under the res

9、ponsibility 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany,

10、Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORM

11、UNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 5360:2012: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo r

12、eproduction or networking permitted without license from IHS-,-,-BS EN ISO 5360:2012EN ISO 5360:2012 (E) 3 Foreword This document (EN ISO 5360:2012) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment“ in collaboration with Technical Committee CEN/TC 215 “Respi

13、ratory 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 July 2012, and conflicting national standards shall be withdrawn at the

14、latest by January 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 5360:2009. This document has b

15、een prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC In

16、ternal 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Lux

17、embourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 5360:2012 has been approved by CEN as a EN ISO 5360:2012 without any modification. Copyright European Committee for Standa

18、rdization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 5360:2012EN ISO 5360:2012 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on

19、medical devices This 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 cited in the Official Journal of t

20、he 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 with the corresponding Essential

21、 Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this International Standard and EU Directive 93/42/EEC Clause(s)/sub-clause(s) of this International Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/notes 4, 5, 6, 7, 9,

22、 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 Clauses 4 to 7 of this stand

23、ard 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 systems Information on rest

24、rictions 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 13.2Standard 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)

25、, 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) continued Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleN

26、o reproduction or networking permitted without license from IHS-,-,-BS EN ISO 5360:2012EN ISO 5360:2012 (E) 5 Table ZA.1 (continued) Clause(s)/sub-clause(s) of this International Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/notes 14.2.1 e) 13.3 f) Consistency acros

27、s 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 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

28、 within the scope of this standard. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 5360:2012ISO 5360:2012(E) ISO 2012 All rights reserved iiiContents Page Foreword iv

29、1 Scope 1 2 Normative references 1 3 Terms and definitions . 1 4 Bottle . 2 5 Bottle collar 4 6 Bottle adaptor 7 7 Filler receptacle . 11 8 Filling rate 13 9 Leakage 15 10 Overfilling protection 15 11 Colour coding 15 12 Usability 15 13 Clinical evaluation . 15 14 Information provided by the manufac

30、turer . 16 14.1 Marking . 16 14.2 Labelling . 16 14.3 Instructions for use . 16 Annex A (informative) Recommendations on materials . 18 Annex B (informative) Types of agent-specific filling systems 19 Annex C (normative) Determination of total leakage into atmosphere of anaesthetic agent during fill

31、ing . 20 Bibliography 21 Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 5360:2012ISO 5360:2012(E) iv ISO 2012 All rights reservedForeword ISO (the International Organi

32、zation 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 body interested in a subject for which a technical committee has been establishe

33、d 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 Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

34、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. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Pub

35、lication 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 document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent

36、 rights. ISO 5360 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines. This third edition cancels and replaces the second edition (ISO 5360:2006), of which it constitutes a minor revision. In particu

37、lar, it indicates in the Scope that requirements of agent-specific filling systems for anaesthetic vaporizers (not merely the dimensions) are specified, transfers the recommendations on materials from the Scope to an informative annex, refers to substances which are carcinogenic, mutagenic or toxic

38、to reproduction in Clause 9 (leakage), introduces new requirements on usability (Clause 12) and clinical evaluation (Clause 13), and amends the requirements on information provided by the manufacturer (renumbered Clause 14). Copyright European Committee for Standardization Provided by IHS under lice

39、nse with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 5360:2012INTERNATIONAL STANDARD ISO 5360:2012(E) ISO 2012 All rights reserved 1Anaesthetic vaporizers Agent-specific filling systems 1 Scope This International Standard specifies requirements, in

40、cluding 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

41、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 references The following referenced documents are indispensable for

42、 the application of this document. 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 tolerancing Tolerances of form, orientatio

43、n, location and run-out 3 Terms and definitions For the purposes of this document, the 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 s

44、ystem functional system of agent-specific coded connections between an anaesthetic bottle 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 s

45、ystems are shown in Annex B. 3.3 anaesthetic vaporizer device designed to facilitate the change of an anaesthetic agent from a liquid to a vapour Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without licen

46、se from IHS-,-,-BS EN ISO 5360:2012ISO 5360:2012(E) 2 ISO 2012 All rights reserved3.4 bottle adaptor assembly that is intended to connect a bottle for liquid anaesthetic agent to an agent-specific anaesthetic vaporizer 3.5 bottle collar agent-specific component on the neck of a bottle causing it to

47、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 neck external threaded part of the bottle and the adjacent contour over which an agent-specific collar is fitted 3.8 filler receptacle re

48、ceptacle 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 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 adaptor complying with 6.2. Copyright European Committee for Standardization Provided by IHS under license with CENNot for R