EN ISO 15002:2008
(Main)Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)
Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)
ISO 15002:2008 is applicable to:
flow-metering devices that are connected, either directly or by means of flexible connecting assemblies, and disconnected by the operator at terminal units of a medical gas pipeline system for flow adjustment, measurement and delivery of medical gases;
flow-metering devices that are connected and disconnected by the operator at gas-specific connection points of devices such as pressure regulators.
ISO 15002:2008 is applicable to:
flow-metering devices intended to be used with the following medical gases:
oxygen;
nitrous oxide;
medical air;
carbon dioxide;
oxygen/nitrous oxide mixture [50 %/50 % (by volume)]
specified mixtures of the gases listed above;
flow-metering devices intended to be used with the following gases:
oxygen-enriched air;
helium;
xenon.
Durchflussmesseinrichtungen zum Anschluss an Entnahmestellen von Rohrleitungssystemen für medizinische Gase (ISO 15002:2008)
1.1 Diese Internationale Norm gilt für:
Durchflussmesseinrichtungen, die durch den Anwender direkt oder mittels flexibler Verbindungssysteme an Entnahmestellen eines Rohrleitungssystems für medizinische Gase zur Durchflusseinstellung, zur Messung und Zuführung von medizinischen Gasen angeschlossen und gelöst werden;
Durchflussmesseinrichtungen, die der Anwender an gasartspezifischen Verbindungsstellen von Geräten wie Druckminderer anschließt oder von diesen löst.
1.2 Diese Internationale Norm gilt für
a) Durchflussmesseinrichtungen, die zur Verwendung mit den folgenden medizinischen Gasen vorgesehen sind:
Sauerstoff;
Distickstoffoxid (Lachgas);
medizinische Luft;
Kohlendioxid;
Sauerstoff-/Lachgasgemische [50 %/50 % (Volumenanteil)];
festgelegte Gemische der oben aufgeführten Gase;
b) Durchflussmesseinrichtungen, die zur Verwendung mit den folgenden Gasen vorgesehen sind:
mit Sauerstoff angereicherte Luft;
Helium;
Xenon.
ANMERKUNG Regionale oder nationale Vorschriften können die Verwendung sauerstoffspezifischer Verbindungs¬stellen für mit Sauerstoff angereicherte Luft zulassen.
1.3 Diese Internationale Norm gilt nicht für elektrische oder elektronische Durchflussmesseinrichtungen.
1.4 Diese Internationale Norm gilt nicht für Gase, die zum Betreiben chirurgischer Werkzeuge verwendet werden.
Dispositifs de mesure de débit pour raccordement aux prises murales des systèmes de distribution de gaz médicaux (ISO 15002:2008)
L'ISO 15002:2008 s'applique aux
dispositifs de contrôle du débit, branchés directement ou au moyen de flexibles de raccordement, et débranchés par l'opérateur au niveau de prises murales d'un système de distribution en gaz médicaux; ces dispositifs servent au réglage du débit, à son mesurage et à la distribution des gaz médicaux,
dispositifs de contrôle du débit branchés et débranchés par l'opérateur à des raccords spécifiques au gaz, de dispositifs tels que des détendeurs.
L'ISO 15002:2008 s'applique aux
dispositifs de contrôle du débit prévus pour être utilisés avec les gaz médicaux suivants:
oxygène;
protoxyde d'azote;
air médical;
dioxyde de carbone;
mélange oxygène/protoxyde d'azote 50/50 (fraction volumique en %).
mélanges spécifiques des gaz listés ci-dessus.
dispositifs de contrôle du débit prévus pour être utilisés avec les gaz suivants:
air enrichi en oxygène;
hélium;
xénon.
Pretočni merilniki za priključitev na končne dele napeljav za medicinske pline (ISO 15002:2008)
Ta mednarodni standard določa zahteve in preskusne metode za ločevalnike amalgama, ki se uporabljajo z zobozdravstveno opremo v zobozdravstvenih centrih. Določa učinkovitost ločevalnikov amalgama glede na raven zadrževanja amalgama, ki temelji na laboratorijskih preskusih in preskusnih postopkih za določanje te učinkovitosti. Prav tako vključuje zahteve za varno delovanje ločevalnikov amalgama, za označevanje ter za navodila za uporabo, delovanje in vzdrževanje. Vsi preskusi, opisani v tem mednarodnem standardu, so tipski preskusi.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2008
1DGRPHãþD
SIST EN 13220:2000
3UHWRþQLPHULOQLNL]DSULNOMXþLWHYQDNRQþQHGHOHQDSHOMDY]DPHGLFLQVNHSOLQH ,62
Flow-metering devices for connection to terminal units of medical gas pipeline systems
(ISO 15002:2008)
Durchflussmesseinrichtungen zum Anschluss an Entnahmestellen von
Rohrleitungssystemen für medizinische Gase (ISO 15002:2008)
Dispositifs de mesure de débit pour raccordement aux prises murales des systemes de
distribution de gaz médicaux (ISO 15002:2008)
Ta slovenski standard je istoveten z: EN ISO 15002:2008
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.
EUROPEAN STANDARD
EN ISO 15002
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2008
ICS 11.040.10 Supersedes EN 13220:1998
English Version
Flow-metering devices for connection to terminal units of
medical gas pipeline systems (ISO 15002:2008)
Dispositifs de mesure de débit pour raccordement aux Durchflussmesseinrichtungen zum Anschluss an
prises murales des systèmes de distribution de gaz Entnahmestellen von Rohrleitungssystemen für
médicaux (ISO 15002:2008) medizinische Gase (ISO 15002:2008)
This European Standard was approved by CEN on 21 June 2008.
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: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15002:2008: E
worldwide for CEN national Members.
Contents Page
Foreword.3
Annex ZA (informative) Correspondence between this International Standard and Directive
93/42/EEC.4
Foreword
This document (EN ISO 15002:2008) 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 January 2009, and conflicting national standards shall be withdrawn at
the latest by July 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 13220:1998.
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 15002:2008 has been approved by CEN as a EN ISO 15002:2008 without any modification.
Annex ZA
(informative)
Correspondence between this International Standard and
Directive 93/42/EEC
This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide one means of conforming to Essential Requirements of
the New Approach Directive 93/42/EEC 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 normative
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 Directive 93/42/EEC
Clause(s)/Sub-clause(s) of Corresponding essential requirements Qualifying remarks/Notes
this International Standard of EU Directive 93/42/EEC
5 1
5.1 2, 6
5.2 2
5.3 2
5.3.1 7.1, 7.3, 9.3
5.3.2 7.3, 9.3
5.3.3 4, 7.1, 9.2
5.3.4 3, 5
5.3.5 7.1, 7.2
5.4 2, 3, 4
5.4.1 9.2, 12.7.4
5.4.1.2 7.2, 7.6
5.4.2 9.2, 12.7.4
5.4.3 9.2, 12.7.1
5.4.4 7.5
5.4.5 9.1
5.4.6.1 10.3, 12.8.2
5.4.6.2 10.2
5.4.6.3 10.1, 12.8.1, 12.8.2
5.4.6.4 12.8.1
Table ZA.1 (continued)
Clause(s)/Sub-clause(s) of Corresponding essential requirements Qualifying remarks/Notes
this International Standard of EU Directive 93/42/EEC
5.4.7.1 10.3, 12.8.2
5.4.7.2 10.2
5.4.7.3 10.1, 12.8.1, 12.8.2
5.4.7.4 12.8.1
5.4.7.5 10
5.4.8.1 10.2
5.4.8.2 10.1, 12.8.1, 12.8.2
5.4.8.3 10.2
5.5.1 7.2, 9.3
5.5.2 7.3, 9.3
6.2 9.2, 12.7.1, 12.7.4
6.3 7.5
6.4 13.2
7.1 13.1, 13.2, 13.3 a), 13.3 d), 13.5
7.2 13.2
7.3 3, 5
7.3.1 5, 7.2, 7.6
7.3.2 13.1, 13.3 b)
8.1 13.1, 13.3 a), 13.4, 13.6 a)
8.2 13.6 c), 13.6 d)
8.3 1st dash 9.3
8.3 2nd dash 9.1, 12.7.4, 13.6 c)
8.3 3rd dash 9.3
8.3 4th dash 10.1, 12.8.1, 12.8.2
8.3 5th dash 10.1, 12.8.1, 12.8.2
8.3 6th dash 10.1, 12.8.1, 12.8.2
8.3 7th dash 10.1, 12.8.1, 12.8.2
8.3 8th dash 10.1, 12.8.1, 12.8.2
8.3 9th dash 10.1, 12.8.1, 12.8.2
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
scope of this standard.
INTERNATIONAL ISO
STANDARD 15002
Second edition
2008-07-01
Flow-metering devices for connection to
terminal units of medical gas pipeline
systems
Dispositifs de mesure de débit pour raccordement aux prises murales
des systèmes de distribution de gaz médicaux
Reference number
ISO 15002:2008(E)
©
ISO 2008
ISO 15002:2008(E)
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ISO 15002:2008(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 *Normative references. 2
3 Terms and definitions. 2
4 Arrangement of flow-metering systems and devices . 4
5 General requirements. 4
5.1 Safety . 4
5.2 Alternative construction . 4
5.3 Materials . 4
5.4 Design requirements . 5
5.5 Constructional requirements. 10
6 Test methods. 10
6.1 General. 10
6.2 Test method for mechanical strength. 11
6.3 Test method for leakage . 11
6.4 Test method for durability of markings and colour coding. 12
7 Marking, colour coding and packaging.12
7.1 Marking . 12
7.2 Colour coding. 13
7.3 Packaging . 13
8 Information to be supplied by the manufacturer. 13
Annex A (informative) Rationale . 15
Annex B (informative) Arrangements of flow-metering systems and devices . 17
Annex C (informative) Environmental aspects. 20
Bibliography . 21
ISO 15002:2008(E)
Foreword
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(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
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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 a
...
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