EN ISO 8536-9:2015

Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015)

ISO 8536-9:2015 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).
The following items are covered by ISO 8536-9:2015:
a)   syringe pump lines (SPL);
b)   connecting lines (CL);
c)   lines with integrated injection cannula (LIC).

Infusionsgeräte zur medizinischen Verwendung - Teil 9: Übertragungsleitungen zur einmaligen Verwendung mit Druckinfusionsapparaten (ISO 8536-9:2015)

Dieser Teil von ISO 8536 gilt für sterilisierte, zur einmaligen Verwendung bestimmte Übertragungsleitungen für Infusionen unter Druckeinwirkung zur Verwendung mit Druckinfusionsapparaten bis maximal 200 kPa (2 bar).
Dieser Teil von ISO 8536 erfasst:
a)   Spritzenpumpenleitungen (SPL);
b)   Verbindungsleitungen (CL);
c)   Leitungen mit integrierter Injektionskanüle (LIC).
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 9: Tubulures non réutilisables avec des appareils de perfusion sous pression (ISO 8536-9:2015)

L'ISO 8536-9:2015 s'applique aux tubulures stériles à usage unique, destinées à être utilisées avec un matériel de perfusion sous une pression maximale de 200 kPa (2 bar).
L'ISO 8536-9:2015 traite des éléments suivants:
a)   les tubulures pour pousse-seringue (SPL);
b)   les prolongateurs (CL);
c)   les tubulures à canule à injection intégrée (LIC).

Infuzijska oprema za uporabo v medicini - 9. del: »Fluidne« cevke za enkratno uporabo z infuzijsko opremo, delujočo na osnovi tlaka (ISO 8536-9:2015)

Ta del standarda ISO 8536 se uporablja za sterilizirane »fluidne« cevke za enkratno uporabo z infuzijsko opremo, delujočo na osnovi tlaka, do največ 200 kPa (2 bara).
Naslednji elementi so vključeni v ta del standarda ISO 8536:
a) cevke s črpalko za brizgo (SPL);
b) priključne cevke (CL);
c) cevke z vgrajenim kanilom za injiciranje (LIC).
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 8536-9:2015 - Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015)

Relations

• Replaces: EN ISO 8536-9:2004 - Infusion equipment for medical use - Part 9: Fluid lines for use with pressure infusion equipment (ISO 8536-9:2004)
• Effective Date: 24-Jun-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8536-9:2015
01-september-2015
1DGRPHãþD
SIST EN ISO 8536-9:2005
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHOª)OXLGQH©FHYNH]DHQNUDWQR
XSRUDER]LQIX]LMVNRRSUHPRGHOXMRþRQDRVQRYLWODND,62
Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure
infusion equipment (ISO 8536-9:2015)
Infusionsgeräte zur medizinischen Verwendung - Teil 9: Übertragungsleitungen zur
einmaligen Verwendung mit Druckinfusionsapparaten (ISO 8536-9:2015)
Matériel de perfusion à usage médical - Partie 9: Tubulures non réutilisables avec des
appareils de perfusion sous pression (ISO 8536-9:2015)
Ta slovenski standard je istoveten z: EN ISO 8536-9:2015
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-9:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8536-9:2015

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SIST EN ISO 8536-9:2015

EUROPEAN STANDARD
EN ISO 8536-9

NORME EUROPÉENNE

EUROPÄISCHE NORM
June 2015
ICS 11.040.20 Supersedes EN ISO 8536-9:2004
English Version
Infusion equipment for medical use - Part 9: Fluid lines for single
use with pressure infusion equipment (ISO 8536-9:2015)
Matériel de perfusion à usage médical - Partie 9: Tubulures Infusionsgeräte zur medizinischen Verwendung - Teil 9:
non réutilisables avec des appareils de perfusion sous Übertragungsleitungen zur einmaligen Verwendung mit
pression (ISO 8536-9:2015) Druckinfusionsapparaten (ISO 8536-9:2015)
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 8536-9:2015 E
worldwide for CEN national Members.

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SIST EN ISO 8536-9:2015
EN ISO 8536-9:2015 (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 8536-9:2015
EN ISO 8536-9:2015 (E)
European foreword
This document (EN ISO 8536-9:2015) 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 8536-9:2004.
In this edition, the following changes have been made:
— the former Clause 3 on designation has been deleted;
— 5.8 has been amended and an appropriate Annex C added;
— Clause 9 on labelling was amended by addition of information regarding the usage of the symbol “XXX”
according ISO 7000, Symbol 2725;
— Clause 10 on disposal has been added;
— A.4 has be
...