SIST EN ISO 5360:2016
(Main)Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2016)
Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2016)
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.
Anästhesiemittelverdampfer - Substanzspezifische Füllsysteme (ISO 5360:2016)
Diese Internationale Norm legt Anforderungen, einschließlich Maße für substanzspezifische Füllsysteme zur Verwendung mit substanzspezifischen Anästhesiemittelverdampfern fest.
Diese Internationale Norm legt keine Werkstoffe für die Konstruktion fest.
ANMERKUNG 1 Empfehlungen für Werkstoffe sind im Anhang A enthalten.
Aufgrund der besonderen Eigenschaften von Desfluran wurden die Maße für dieses Anästhesiemittel nicht in dieser Internationalen Norm festgelegt.
ANMERKUNG 2 Es werden Ausführungen von solchen Anschlusssystemen unterstützt, die das Eingreifen der substanzspezifischen Flaschenadapter in die Flasche nur dann zulassen, wenn der Flaschenkragen am richtigen Platz ist.
Évaporateurs d'anesthésie - Systèmes de remplissage spécifiques à l'agent (ISO 5360:2016)
ISO 5360:2016 spécifie les exigences, y compris les dimensions, relatives aux systèmes de remplissage spécifiques à l'agent utilisés avec des évaporateurs d'anesthésie spécifiques à l'agent.
ISO 5360:2016 ne spécifie pas les matériaux constitutifs utilisés.
NOTE 1 Voir l'Annexe A pour les recommandations applicables aux matériaux.
En raison des propriétés uniques du desflurane, les dimensions pour cet agent n'ont pas été spécifiées dans la présente Norme internationale.
NOTE 2 On encourage la conception de systèmes de raccordement ne permettant l'emboîtement de l'adaptateur de flacon spécifique à l'agent qu'avec le flacon lorsque l'anneau de flacon est en place.
Anestezijski hlapilniki (vaporizatorji) - Sistemi za nalivanje posebnih hlapnih anestetikov (ISO 5360:2016)
Ta mednarodni standard določa zahteve, vključno z dimenzijami, za sisteme za nalivanje posebnih hlapnih anestetikov za posebne anestezijske hlapilnike (vaporizatorje).
Ta mednarodni standard ne določa gradbenih materialov.
OPOMBA 1: Priporočila glede materialov so na voljo v dodatku A.
Dimenzije za ta anestetik zaradi posebnih lastnosti desflurana niso navedene v tem mednarodnem standardu.
OPOMBA 2: Spodbujajo se zasnove priključnih sistemov, ki nameščanje posebnega pretvornika za steklenice na steklenico omogočajo le, ko je nameščen trak za steklenico.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 5360:2016
01-maj-2016
1DGRPHãþD
SIST EN ISO 5360:2012
Anestezijski hlapilniki (vaporizatorji) - Sistemi za nalivanje posebnih hlapnih
anestetikov (ISO 5360:2016)
Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2016)
Anästhesiemittelverdampfer - Substanzspezifische Füllsysteme (ISO 5360:2016)
Évaporateurs d'anesthésie - Systèmes de remplissage spécifiques à l'agent (ISO
5360:2016)
Ta slovenski standard je istoveten z: EN ISO 5360:2016
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 5360:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 5360:2016
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SIST EN ISO 5360:2016
EN ISO 5360
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2016
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 5360:2012
English Version
Anaesthetic vaporizers - Agent-specific filling systems (ISO
5360:2016)
Évaporateurs d'anesthésie - Systèmes de remplissage Anästhesiemittelverdampfer - Substanzspezifische
spécifiques à l'agent (ISO 5360:2016) Füllsysteme (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 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, 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 Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR 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 Ref. No. EN ISO 5360:2016 E
worldwide for CEN national Members.
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SIST EN ISO 5360:2016
EN ISO 5360:2016 (E)
Contents
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices . 4
2
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SIST EN ISO 5360:2016
EN ISO 5360:2016 (E)
European foreword
This document (EN ISO 5360:2016) has been 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 by 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 CENELEC] 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 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 Standard: 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, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
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.
3
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SIST EN ISO 5360:2016
EN ISO 5360:2016 (E)
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 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 European Standard and EU Directive 93/42/EEC
Clause(s)/sub-clause(s) of Essential Requirements (ERs) of
Qualifying remarks/notes
this European Standard Directive 93/42/EEC
4, 5, 6, 7, 9, 10 7.5, first paragraph, first sentence
Only the presence of phthalates is
addressed; Presumption of conformity to
14.3 f), 14.2.1 last paragraph 7.5, second paragraph
labelling requirement only provided if the
symbol defined in EN 15896 is used
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
4, 5, 6, 7, 9 and 11 9.1 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
Standard specifies colour coding of the
11 13.2 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
Presumption of conformity to ER 13.3 d)
14.1 b) 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)
4
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SIST EN ISO 5360:2016
EN ISO 5360:2016 (E)
Consistency across the Community is not
14.2.1 e) 13.3 f)
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 the scope of this standard.
5
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SIST EN ISO 5360:2016
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SIST EN ISO 5360:2016
INTERNATIONAL ISO
STANDARD 5360
Fourth edition
2016-02-15
Anaesthetic vaporizers — Agent-
specific filling systems
Évaporateurs d’anesthésie — Systèmes de remplissage spécifiques à
l’agent
Reference number
ISO 5360:2016(E)
©
ISO 2016
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SIST EN ISO 5360:2016
ISO 5360:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 5360:2016
ISO 5360:2016(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Bottle . 2
5 Bottle collar . 3
6 Bottle adaptor . 6
7 Filler receptacle .10
8 Filling rate .12
9 Leakage.14
10 Overfilling protection .14
11 Colour coding .14
12 Usability .14
13 Clinical evaluation .14
14 Information provided by the manufacturer .15
14.1 Marking .15
14.2 Labelling .15
14.3 Instructions for use .15
Annex A (informative) Recommendations on materials .17
Annex B (informative) Types of agent-specific filling systems .18
Annex C (normative) Determination of total leakage into atmosphere of anaesthetic agent
during filling .19
Bibliography .21
© ISO 2016 – All rights reserved iii
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SIST EN ISO 5360:2016
ISO 5360:2016(E)
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.
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 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 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 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 ISO’s adherence to the WTO principles in the Technical
Barriers 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 (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.
iv © ISO 2016 – All rights reserved
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SIST EN ISO 5360:2016
INTERNATIONAL STANDARD ISO 5360:2016(E)
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 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 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 (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 filler receptacle (3.8)
Note 1 to entry: 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
3.4
bottle adaptor
assembly that is intended to connect a bottle for liquid anaesthetic agent to an agent-specific (3.1)
anaesthetic vaporizer (3.3)
3.5
bottle collar
agent-specific (3.1) component on the neck of a bottle causing it to be agent-specific (3.1)
© ISO 2016 – All rights reserved 1
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β
β
α
α
SIST EN ISO 5360:2016
ISO 5360:2016(E)
3.6
bottle connector
agent-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)
3.7
bottle neck
external threaded part of the bottle and the adjacent contour over which an agent-specific (3.1)
collar is fitted
3.8
filler receptacle
receptacle for a bottle or a bottle adaptor (3.4) on an agent-specific (3.1) anaesthetic vaporizer (3.3)
3.9
male adaptor
part of a bottle adaptor (3.4) that mates with a filler receptacle (3.8) on an agent-specific (3.1) vaporizer
4 Bottle
Each bottle shall have the following:
a) 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.
Dimensions in millimetres
Ød
1 1
ØD ØD
2 2
ØD ØD
3 3
a a aa
0,25 0,2 0,25 0,2
≥0,75 ≥0,75
ØD Ød
1
ØD
1
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
2 © ISO 2016 – All rights reserved
h
2
h
1
s
p
h
2
h
1
s
p
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SIST EN ISO 5360:2016
ISO 5360:2016(E)
Table 1 — Dimensions of threaded necks of bottles for anaesthetic agents
a a b b
h h s α min. Thread D D D d
1 2 1 2 3
Bottle Anaesthetic p
±0,3 min. ±0,45 β at turns nom. ±0,3 ±0,3 max.
type agent mm
mm mm mm ∅D min. mm mm mm mm
1
Isoflurane
1 9,75 23 1,2 2° 35′ 30° 3,2 1 28 23,6 21,5 28
Enflurane
2 Halothane 6,8 18,7 1,2 2° 15′ 30° 2,54 1,25 24 21,45 19,7 28
Halothane
3 15 26,3 1 2° 50′ 30° 3,2 1,75 24 21,7 19,5 28
(USA)
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
Methoxy-
6 9,8 20 1,15 2° 57′ 30° 4,25 1,25 30 27,3 24,9 32
flurane
7 Spare 9,85 20 1,15 2° 31′ 30° 4,25 1,25 34 31,8 29,4 32
8 Sevoflurane 8,9
...
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