EN ISO 8536-8:2004
(Main)Infusion equipment for medical use - Part 8: Infusion equipment for use with pressure infusion apparatus (ISO 8536-8:2004)
Infusion equipment for medical use - Part 8: Infusion equipment for use with pressure infusion apparatus (ISO 8536-8:2004)
ISO 8536-8:2004 applies to sterilized infusion sets for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).
Infusionsgeräte zur medizinischen Verwendung - Teil 8: Infusionsgeräte zur Verwendung mit Druckinfusionsapparaten (ISO 8536-8:2004)
Dieser Teil von ISO 8536 gilt für sterilisierte, zur einmaligen Verwendung bestimmte Infusionsgeräte für Infusionen unter Druckeinwirkung zur Verwendung mit Druckinfusionsapparaten bis maximal 200 kPa (2 bar).
Matériel de perfusion à usage médical - Partie 8: Matériel de perfusion pour utilisation avec des appareils de perfusion sous pression (ISO 8536-8:2004)
Infuzijska oprema za uporabo v medicini - 8. del: Infuzijska oprema za uporabo s tlačno črpalko (ISO 8536-8:2004)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8536-8:2005
01-marec-2005
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO ,QIX]LMVNDRSUHPD]DXSRUDERV
WODþQRþUSDONR ,62
Infusion equipment for medical use - Part 8: Infusion equipment for use with pressure
infusion apparatus (ISO 8536-8:2004)
Infusionsgeräte zur medizinischen Verwendung - Teil 8: Infusionsgeräte zur Verwendung
mit Druckinfusionsapparaten (ISO 8536-8:2004)
Matériel de perfusion a usage médical - Partie 8: Matériel de perfusion pour utilisation
avec des appareils de perfusion sous pression (ISO 8536-8:2004)
Ta slovenski standard je istoveten z: EN ISO 8536-8:2004
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-8:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8536-8:2005
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SIST EN ISO 8536-8:2005
EUROPEAN STANDARD
EN ISO 8536-8
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2004
ICS 11.040.20
English version
Infusion equipment for medical use - Part 8: Infusion equipment
for use with pressure infusion apparatus (ISO 8536-8:2004)
Matériel de perfusion à usage médical - Partie 8: Matériel Infusionsgeräte zur medizinischen Verwendung - Teil 8:
de perfusion pour utilisation avec des appareils de Infusionsgeräte zur Verwendung mit
perfusion sous pression (ISO 8536-8:2004) Druckinfusionsapparaten (ISO 8536-8:2004)
This European Standard was approved by CEN on 29 July 2004.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-8:2004: E
worldwide for CEN national Members.
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SIST EN ISO 8536-8:2005
EN ISO 8536-8:2004 (E)
Foreword
This document (EN ISO 8536-8:2004) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection equipment for medical and pharmaceutical use" in
collaboration with Technical Committee CEN/TC 205 “Non-active medical devices”, 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 February 2005, and conflicting national
standards shall be withdrawn at the latest by February 2005.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 8536-8:2004 has been approved by CEN as EN ISO 8536-8:2004 without any
modifications.
2
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SIST EN ISO 8536-8:2005
INTERNATIONAL ISO
STANDARD 8536-8
First edition
2004-08-15
Infusion equipment for medical use —
Part 8:
Infusion equipment for use with pressure
infusion apparatus
Matériel de perfusion à usage médical —
Partie 8: Matériel de perfusion pour utilisation avec des appareils de
perfusion sous pression
Reference number
ISO 8536-8:2004(E)
©
ISO 2004
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SIST EN ISO 8536-8:2005
ISO 8536-8:2004(E)
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