EN ISO 80369-20:2015

Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015)

ISO 80369-20:2015 specifies the test methods to evaluate the performance requirements for small-bore connectors specified in the ISO 80369‑ series.

Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 20: Allgemeine Prüfverfahren (ISO 80369-20:2015)

Der vorliegende Teil der ISO 80369 legt die PRÜFVERFAHREN zur Unterstützung der Funktionsanforderungen für VERBINDUNGSSTÜCKE mit KLEINEM DURCHMESSER zur Verwendung für VERBINDUNGEN von MEDIZIN¬PRODUKTEN und entsprechenden ZUBEHÖRTEILEN fest. Der vorliegende Teil der ISO 80369 legt nicht die Funktionsanforderungen für die MEDIZINPRODUKTE oder ZUBEHÖRTEILE fest, mit denen diese VERBINDUNGSSTÜCKE verwendet werden. Derartige Anforderungen sind in den einzelnen Internationalen Normen für spezifische MEDIZINPRODUKTE oder ZUBEHÖRTEILE angegeben.

Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 20: Méthodes d'essai communes (ISO 80369-20:2015)

L'ISO 80369-20:2015 spécifie les méthodes d'essai qui permettent d'évaluer les exigences de performance relatives aux raccords de petite taille spécifiés dans la série de l'ISO 80369.

Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 20. del: Splošne preskusne metode (ISO 80369-20:2015)

Ta del standarda ISO 80369 določa funkcionalne zahteve za PRIKLJUČKE Z MAJHNIM PREMEROM, namenjene uporabi za POVEZAVE MEDICINSKIH PRIPOMOČKOV in povezane DODATKE. Ta del standarda ISO 80369 določa funkcionalne zahteve za bistvene lastnosti PRIKLJUČKOV Z MAJHNIM PREMEROM. Ta del standarda ISO 80369 ne določa funkcionalnih zahtev za MEDICINSKE PRIPOMOČKE ali DODATKE, v katerih se uporabljajo ti PRIKLJUČKI. Takšne zahteve so podane v zadevnih mednarodnih standardih za posamezne MEDICINSKE PRIPOMOČKE ali DODATKE.

General Information

• Status: Published
• Publication Date: 19-May-2015
• Withdrawal Date: 29-Nov-2015
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CEN/CLC/JTC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/CLC/JTC 3 - Quality management and corresponding general aspects for medical devices
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 20-May-2015
• Due Date: 21-Feb-2016
• Completion Date: 20-May-2015
• Directive: 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 80369-20:2015 - Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 80369-20:2015
01-september-2015
3ULNOMXþNL]PDMKQLPSUHPHURP]DWHNRþLQHLQSOLQH]DXSRUDERY]GUDYVWYX
GHO6SORãQHSUHVNXVQHPHWRGH,62
Small-bore connectors for liquids and gases in healthcare applications - Part 20:
Common test methods (ISO 80369-20:2015)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 20: Allgemeine Prüfverfahren (ISO 80369-20:2015)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
20: Méthodes d'essai courantes (ISO 80369-20:2015)
Ta slovenski standard je istoveten z: EN ISO 80369-20:2015
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 80369-20:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 80369-20:2015

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SIST EN ISO 80369-20:2015

EUROPEAN STANDARD
EN ISO 80369-20

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2015
ICS 11.040.25
English Version
Small-bore connectors for liquids and gases in healthcare
applications - Part 20: Common test methods (ISO 80369-
20:2015)
Raccords de petite taille pour liquides et gaz utilisés dans le Verbindungsstücke mit kleinem Durchmesser für
domaine de la santé - Partie 20: Méthodes d'essai Flüssigkeiten und Gase in medizinischen Anwendungen -
communes (ISO 80369-20:2015) Teil 20: Allgemeine Prüfverfahren (ISO 80369-20:2015)
This European Standard was approved by CEN on 5 March 2015.

CEN and CENELEC 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 and CENELEC
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 and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre
has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees 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
© 2015 All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80369-20:2015 E
CEN/CENELE worldwide for CEN national Members and for CENELEC Members.
C

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SIST EN ISO 80369-20:2015
EN ISO 80369-20:2015 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this part of EN ISO 80369 and the essential
requirements of EU Directive 93/42/EEC .4
2

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SIST EN ISO 80369-20:2015
EN ISO 80369-20:2015 (E)
Foreword
This document (EN ISO 80369-20:2015) has been prepared by Technical Committee ISO/TC 210 “Quality
management and corresponding general aspects for medical devices” in collaboration with Technical
Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” the
secretariat of which is held by NEN.
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 November 2015, and conflicting national standards shall be withdrawn
at the latest by November 2015.
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 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 t
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