EN ISO 5360:2012

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Anestezijski hlapilniki (vaporizatorji) - Sistemi za nalivanje posebnih hlapnih anestetikov (ISO 5360:2012)Évaporateurs d'anesthésie - Systèmes de remplissage spécifiques à l'agent (ISO 5360:2012)Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2012)11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN ISO 5360:2012SIST EN ISO 5360:2012en01-april-2012SIST EN ISO 5360:2012SLOVENSKI
STANDARDSIST EN ISO 5360:20091DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE 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)
Évaporateurs d'anesthésie - Systèmes de remplissage spécifiques à l'agent (ISO 5360:2012)
Anästhesiemittelverdampfer - Substanzspezifische Füllsysteme (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 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). 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, 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, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
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: ESIST EN ISO 5360:2012

European
Standard and the Essential Requirements
of EU Directive 93/42/EEC on medical devices .4 SIST EN ISO 5360:2012

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, Bulgaria, Croatia, 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, 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. SIST EN ISO 5360:2012

European
Standard and the Essential Requirements
of EU Directive 93/42/EEC on 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 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 with the corresponding Essential 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, 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 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 systems 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)
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)
continued SIST EN ISO 5360:2012

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 the scope of this standard. SIST EN ISO 5360:2012

Reference numberISO 5360:2012(E)© ISO 2012
INTERNATIONAL STANDARD ISO5360Third edition2012-01-15Anaesthetic vaporizers — Agent-specific filling systems Évaporateurs d'anesthésie — Systèmes de remplissage spécifiques à l'agent
ISO 5360:2012(E)
©
ISO 2012 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56  CH-1211 Geneva 20 Tel.
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ii © ISO 2012 – All rights reserved
ISO 5360:2012(E) © ISO 2012 – All rights reserved iii Contents Page Foreword . iv 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 manufacturer . 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 filling . 20 Bibliography . 21
ISO 5360:2012(E) iv © ISO 2012 – All rights reserved 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 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 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. 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 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 third edition cancels and replaces the second edition (ISO 5360:2006), of which it constitutes a minor revision. In particular, 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 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).
INTERNATIONAL STANDARD ISO 5360:2012(E) © ISO 2012 – All rights reserved 1 Anaesthetic vaporizers — Agent-specific filling systems 1 Scope This 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 unique 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 references The following referenced documents are indispensable for 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, orientation, 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 system 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 systems 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 SIST EN ISO 5360:2012

ISO 5360:2012(E) 2 © ISO 2012 – All rights reserved 3.4 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 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 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 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. SIST EN ISO 5360:2012

ISO 5360:2012(E) © ISO 2012 – All rights reserved 3 Dimensions in millimetres
Key 1 optional pouring lip (dimension not specified) a Flatness 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 threaded necks of bottles for anaesthetic agents Table 1 — Dimensions of threaded necks of bottles for anaesthetic agents Bottle type Anaesthetic agent h1  0,3 mm h2a min. mm s  0,45mm   min. at D1 p
mm Thread turnsmin. D1a nom. mm D2b  0,3 mm D3b  0,3mm 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 Halothane (USA) 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 Sevoflurane 8,9 23,9 1,3 2° 56 30° 3,63 1,25 23,9 23,5 21,5 28 NOTE See Figure 1. 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. SIST EN ISO 5360:2012

ISO 5360:2012(E) 4 © ISO 2012 – All rights reserved 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
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