EN ISO 8536-8:2015

Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015)

ISO 8536-8:2015 gives users information on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa (2 bar).

Infusionsgeräte zur medizinischen Verwendung - Teil 8: Infusionsgeräte zur einmaligen Verwendung mit Druckinfusionsapparaten (ISO 8536-8:2015)

Dieser Teil von ISO 8536 liefert den Anwendern Angaben über sterilisierte Infusionsgeräte zur einmaligen Verwendung mit Druckinfusionsapparaten bis zu einem Maximaldruck von 200 kPa (2 bar).
In einigen Ländern sind das nationale Arzneibuch oder andere nationale Bestimmungen rechtlich bindend und haben Vorrang vor diesem Teil von ISO 8536.

Matériel de perfusion à usage médical - Partie 8: Appareils de perfusion non réutilisables avec des appareils de perfusion sous pression (ISO 8536-8:2015)

L'ISO 8536-8:2015 donne aux utilisateurs des informations sur les appareils de perfusion stérilisés non réutilisables avec des appareils de perfusion sous pression jusqu'à 200 kPa (2 bar) maximum.

Infuzijska oprema za uporabo v medicini - 8. del: Infuzijski seti za enkratno uporabo s tlačno črpalko (ISO 8536-8:2015)

Ta del standarda ISO 8536 uporabnikom zagotavlja informacije o steriliziranih infuzijskih setih za enkratno uporabo s tlačno
črpalko do največ 200 kPa (2 bara).
V nekaterih državah je nacionalna farmakopeja ali druga nacionalna zakonodaja pravno zavezujoča in ima prednost pred tem delom standarda ISO 8536.

General Information

• Status: Published
• Publication Date: 16-Jun-2015
• Withdrawal Date: 30-Dec-2015
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 17-Jun-2015
• Completion Date: 17-Jun-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 8536-8:2015 - Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015)

Relations

• Replaces: EN ISO 8536-8:2004 - Infusion equipment for medical use - Part 8: Infusion equipment for use with pressure infusion apparatus (ISO 8536-8:2004)
• Effective Date: 29-May-2013

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8536-8:2015
01-september-2015
1DGRPHãþD
SIST EN ISO 8536-8:2005
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO,QIX]LMVNLVHWL]DHQNUDWQR
XSRUDERVWODþQRþUSDONR,62
Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure
infusion apparatus (ISO 8536-8:2015)
Infusionsgeräte zur medizinischen Verwendung - Teil 8: Infusionsgeräte zur einmaligen
Verwendung mit Druckinfusionsapparaten (ISO 8536-8:2015)
Matériel de perfusion à usage médical - Partie 8: Appareils de perfusion non réutilisables
avec des appareils de perfusion sous pression (ISO 8536-8:2015)
Ta slovenski standard je istoveten z: EN ISO 8536-8:2015
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-8:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8536-8:2015

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SIST EN ISO 8536-8:2015

EUROPEAN STANDARD
EN ISO 8536-8

NORME EUROPÉENNE

EUROPÄISCHE NORM
June 2015
ICS 11.040.20 Supersedes EN ISO 8536-8:2004
English Version
Infusion equipment for medical use - Part 8: Infusion sets for
single use with pressure infusion apparatus (ISO 8536-8:2015)
Matériel de perfusion à usage médical - Partie 8: Appareils Infusionsgeräte zur medizinischen Verwendung - Teil 8:
de perfusion non réutilisables avec des appareils de Infusionsgeräte zur einmaligen Verwendung mit
perfusion sous pression (ISO 8536-8:2015) Druckinfusionsapparaten (ISO 8536-8:2015)
This European Standard was approved by CEN on 16 April 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
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-8:2015 E
worldwide for CEN national Members.

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SIST EN ISO 8536-8:2015
EN ISO 8536-8:2015 (E)
Contents Page
European foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EC Directive 93/42/EEC on medical devices .5

2

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SIST EN ISO 8536-8:2015
EN ISO 8536-8:2015 (E)
European foreword
This document (EN ISO 8536-8:2015) has been prepared by Technical Committee ISO/TC 76 “Transfusion,
infusion and injection, and blood processing 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 DIN.
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 December 2015, and conflicting national standards shall be withdrawn
at the latest by December 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 supersedes EN ISO 8536-8:2004.
In this edition the following changes have been made:
— the part title has been changed from 'Infusion equipment …' to 'Infusion sets …';
— the former Clause 4 on designation has been deleted;
— 6.14 has been amended and an appropriate Annex B 'Storage volume' added;
— Clause 10 on labelling was amended by a note regarding the usage of the symbol “XXX” according
ISO
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