EN ISO 5360:2016
(Main)Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2016)
Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2016)
ISO 5360:2016 specifies requirements, including dimensions, for agent-specific filling systems for agent-specific anaesthetic vaporizers.
ISO 5360:2016 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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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.
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)
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.
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
ISO 5360:2016(E)
© ISO 2016, Published in Switzerland
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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 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
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