SIST EN ISO 5360:2009
(Main)Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)
Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)
This International Standard specifies the dimensions of agent-specific filling systems for agent-specific anaesthetic vaporizers. This International Standard does not specify construction materials. Materials used for the parts of filling systems which come into contact with liquid anaesthetic agent should be selected with regard to: a) toxicity; b) compatibility with anaesthetic agents; c) minimization of health risks due to substances leached from the materials. Because of the unique properties of desflurane, dimensions for this agent have not been specified in this International Standard.
Anästhesiemittelverdampfer - Substanzspezifische Füllsysteme (ISO 5360:2006)
Diese Internationale Norm legt Maße für substanzspezifische Füllsysteme zur Verwendung mit substanzspezifischen
Anästhesiemittelverdampfern fest.
Diese Internationale Norm legt keine Werkstoffe für die Konstruktion fest. Werkstoffe für diejenigen Teile des
substanzspezifischen Füllsystems, die mit flüssigem Anästhesiemittel in Berührung kommen, sollten
ausgewählt werden im Hinblick auf:
a) Toxizität;
b) Verträglichkeit mit Anästhesiemitteln;
c) Herabsetzung von Gesundheitsrisiken infolge von Substanzen, die aus dem Werkstoff herausgelöst
werden.
Aufgrund der besonderen Eigenschaften von Desfluran wurden die Maße für dieses Anästhesiemittel nicht in
dieser Internationalen Norm festgelegt.
ANMERKUNG Ausführungen von Anschlusssystemen werden unterstützt, die das Eingreifen der substanzspezifischen
Flaschenadapter in die Flasche nur dann zulassen, wenn der Flaschenkragen am richtigen Platz ist.
Evaporateurs d'anesthésie - Systèmes de remplissage spécifiques à l'agent (ISO 5360:2006)
L'ISO 5360:2006 spécifie les dimensions des systèmes de remplissage spécifiques à l'agent utilisés avec des évaporateurs d'anesthésie spécifiques à l'agent.
L'ISO 5360:2006 ne spécifie pas les matériaux utilisés.
En raison des propriétés uniques du desflurane, les dimensions pour cet agent n'ont pas été spécifiées dans l'ISO 5360:2006.
Anestezijski hlapilniki (vaporizatorji) - Sistemi za nalivanje posebnih hlapnih anestetikov (ISO 5360:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 5360:2009
01-junij-2009
1DGRPHãþD
SIST EN ISO 5360:2008
Anestezijski hlapilniki (vaporizatorji) - Sistemi za nalivanje posebnih hlapnih
anestetikov (ISO 5360:2006)
Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)
Anästhesiemittelverdampfer - Substanzspezifische Füllsysteme (ISO 5360:2006)
Evaporateurs d'anesthésie - Systèmes de remplissage spécifiques à l'agent (ISO
5360:2006)
Ta slovenski standard je istoveten z: EN ISO 5360:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 5360:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 5360:2009
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SIST EN ISO 5360:2009
EUROPEAN STANDARD
EN ISO 5360
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 5360:2007
English Version
Anaesthetic vaporizers - Agent-specific filling systems (ISO
5360:2006)
Évaporateurs d'anesthésie - Systèmes de remplissage Anästhesiemittelverdampfer - Substanzspezifische
spécifiques à l'agent (ISO 5360:2006) Füllsysteme (ISO 5360:2006)
This European Standard was approved by CEN on 21 March 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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 and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5360:2009: E
worldwide for CEN national Members.
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SIST EN ISO 5360:2009
EN ISO 5360:2009 (E)
Contents Page
Foreword .3
Annex ZA (Informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 5360:2009
EN ISO 5360:2009 (E)
Foreword
The text of ISO 5360:2006 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 5360:2009 by 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 October 2009, and conflicting national standards shall be withdrawn at
the latest by March 2010.
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 5360:2007.
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 EC Directive.
For relationship with EC Directive, 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, 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 and the United Kingdom.
Endorsement notice
The text of ISO 5360:2006 has been approved by CEN as a EN ISO 5360:2009 without any modification.
3
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SIST EN ISO 5360:2009
EN ISO 5360:2009 (E)
Annex ZA
(Informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
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 on medical devices.
Once this standard is cited in the Official Journal of the European Communities 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 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 – Correspondence between this European Standard and EU Directives
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying
EN Directive 93/42/EEC remarks/Notes
4 1 (first paragraph), 2, 9.1
5 1 (first paragraph), 2, 9.1
6 1 (first paragraph), 2, 7.5 (first
paragraph, first sentence), 9.1
6.6 4
7 1 (first paragraph), 2, 9.1
8 1 (first paragraph), 2, 3
9 1 (first paragraph), 2, 3, 4, 5, 6, 7.5 (first
paragraph, first sentence), 9.1
10 1 (first paragraph), 2, 3, 4, 9.1
11 2, 9.1, 13.2
12.1 13.5
12.1 a) 13.3 a) This Essential
Requirement is not fully
addressed in this EN
12.1 c) 13.3 b)
12.2.1 a) 13.3 a)
12.2.1 b) 13.3 b)
12.2.1 c) 13.3 b)
12.2.1 d) 13.3 e)
4
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SIST EN ISO 5360:2009
EN ISO 5360:2009 (E)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying
EN Directive 93/42/EEC remarks/Notes
12.2.1 e) 13.3.f) This Essential
Requirement is not fully
addressed in this EN
12.2.1 f) 13.3 f), 13.3 i) This Essential
Requirement is not fully
addressed in this EN
12.2.2 6, 7.6, 9.1, 13.3 k)
12.3 a) 13.6 a)
12.3 b) 6, 7.6, 9.1, 13.3 k)
12.3 c) 13.6 b), 13.6 d)
12.3 d) 13.6 d)
12.3 e) 13.3 k)
- 1 (1st and 2nd paragraph, 1st and 2nd These relevant Essential
dash) Requirements are not
addressed in this
European Standard
- 6a This relevant Essential
Requirement is not
addressed in this
European Standard
- 7.5 (1st paragraph, 1st and 2nd These relevant Essential
sentence and 2nd and 3rd paragraphs) Requirements are not
addressed in this
European Standard
12 13.1
- 13.6 h) This relevant Essential
Requirement is not
addressed in this
European Standard
- 13.6 (q) This relevant Essential
Requirement is not
addressed in this
European Standard
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 5360:2009
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SIST EN ISO 5360:2009
INTERNATIONAL ISO
STANDARD 5360
Second edition
2006-10-01
Anaesthetic vaporizers — Agent-specific
filling systems
Évaporateurs d'anesthésie — Systèmes de remplissage spécifiques à
l'agent
Reference number
ISO 5360:2006(E)
©
ISO 2006
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SIST EN ISO 5360:2009
ISO 5360:2006(E)
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ii © ISO 2006 – All rights reserved
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SIST EN ISO 5360:2009
ISO 5360:2006(E)
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. 8
7 Filler receptacle. 12
8 Filling rate. 14
9 Leakage. 16
10 Overfilling protection. 16
11 Colour coding. 16
12 Information provided by the manufacturer . 16
Annex A (informative) Types of agent-specific filling systems. 18
Annex B (normative) Determination of total leakage into atmosphere of anaesthetic agent during
filling. 19
Bibliography . 21
© ISO 2006 – All rights reserved iii
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SIST EN ISO 5360:2009
ISO 5360:2006(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.
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 second edition cancels and replaces the first edition (ISO 5360:1993) which has been technically revised
by virtue of incorporation of Technical Corrigendum 1:1998, inclusion of the changes presented and approved
for ISO 5360:1993/Amd 1 (not published) and the need to update cross-references and other factual matters
due to the passage of time.
iv © ISO 2006 – All rights reserved
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SIST EN ISO 5360:2009
INTERNATIONAL STANDARD ISO 5360:2006(E)
Anaesthetic vaporizers — Agent-specific filling systems
1 Scope
This International Standard specifies the dimensions of agent-specific filling systems for agent-specific
anaesthetic vaporizers.
This International Standard does not specify construction materials. Materials used for the parts of filling
systems which come into contact with liquid anaesthetic agent should be selected with regard to:
a) toxicity;
b) compatibility with anaesthetic agents;
c) minimization of health risks due to substances leached from the materials.
Because of the unique properties of desflurane, dimensions for this agent have not been specified in this
International Standard.
NOTE Designs of connection systems are encouraged which only permit engagement of the agent-specific bottle
adaptor to the bottle when the bottle collar is in place.
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 1101:2004, 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 A.
© ISO 2006 – All rights reserved 1
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SIST EN ISO 5360:2009
ISO 5360:2006(E)
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 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.
2 © ISO 2006 – All rights reserved
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SIST EN ISO 5360:2009
ISO 5360:2006(E)
Dimensions in millimetres
Key
1 optional pouring lip (not dimensioned)
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 also 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 (see also Figure 1)
a a b b
h h s α min. Thread D D D d
1 2 1 2 3
Bottle Anaesthetic
± 0,3 min. ± 0,45 β at p mm turns nom. ± 0,3
...
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