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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

Status
Published
Publication Date
15-Mar-2016
Withdrawal Date
15-Mar-2019
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
16-Mar-2016
Completion Date
16-Mar-2016
Directive
2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN ISO 5360:2016 - Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2016)

Relations

Replaces
EN ISO 5360:2012 - Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2012)
Effective Date
18-Feb-2015

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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
...

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