SIST EN ISO 8536-9:2005

Infusion equipment for medical use - Part 9: Fluid lines for use with pressure infusion equipment (ISO 8536-9:2004)

Applies exclusively to sterilised fluid lines for single use for use with pressure infusion apparatus up to a maximum of 200 kPa (2 bar). The following items are covered: Syringe pump lines (SPL), Connecting lines (CL), Lines with integrated injection catheters (LIC).

Infusionsgeräte zur medizinischen Verwendung - Teil 9: Übertragungsleitungen zur Verwendung mit Druckinfusionsapparaten (ISO 8536-9:2004)

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).
Von dieser Norm werden erfasst:
a)   Spritzenpumpenleitungen (SPL)
b)   Verbindungsleitungen (CL)
c)   Leitungen mit integrierter Injektionskanüle (LIC).

Matériel de perfusion a usage médical - Partie 9: Tubulures pour utilisation avec des appareils de perfusion sous pression (ISO 8536-9:2004)

L'ISO 8536-9:2004 s'applique aux tubulures stériles à usage unique, destinées à être utilisées avec des appareils de perfusion sous une pression maximale de 200 kPA (2 bar).
L'ISO 8536-9:2004 traite des éléments suivants:
les tubulures pour pousse-seringue (SPL);
les prolongateurs (CL);
les tubulures à canule à injection intégrée (LIC).

Infuzijska oprema za uporabo v medicini - 9. del: »Fluidne« cevke za uporabo z infuzijsko opremo, delujočo na osnovi tlaka (ISO 8536-9:2004)

General Information

• Status: Withdrawn
• Publication Date: 28-Feb-2005
• Withdrawal Date: 04-Aug-2015
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 05-Aug-2015
• Due Date: 28-Aug-2015
• Completion Date: 05-Aug-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN ISO 8536-9:2004 - Infusion equipment for medical use - Part 9: Fluid lines for use with pressure infusion equipment (ISO 8536-9:2004)

Relations

• Replaced By: 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)
• Effective Date: 01-Sep-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8536-9:2005
01-marec-2005
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHOª)OXLGQH©FHYNH]DXSRUDER]
LQIX]LMVNRRSUHPRGHOXMRþRQDRVQRYLWODND,62
Infusion equipment for medical use - Part 9: Fluid lines for use with pressure infusion
equipment (ISO 8536-9:2004)
Infusionsgeräte zur medizinischen Verwendung - Teil 9: Übertragungsleitungen zur
Verwendung mit Druckinfusionsapparaten (ISO 8536-9:2004)
Matériel de perfusion a usage médical - Partie 9: Tubulures pour utilisation avec des
appareils de perfusion sous pression (ISO 8536-9:2004)
Ta slovenski standard je istoveten z: EN ISO 8536-9:2004
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-9:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8536-9:2005

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SIST EN ISO 8536-9:2005
EUROPEAN STANDARD
EN ISO 8536-9
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2004
ICS 11.040.20
English version
Infusion equipment for medical use - Part 9: Fluid lines for use
with pressure infusion equipment (ISO 8536-9:2004)
Matériel de perfusion à usage médical - Partie 9: Tubulures
pour utilisation avec des appareils de perfusion sous
pression (ISO 8536-9:2004)
This European Standard was approved by CEN on 30 September 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 8536-9:2004: E
worldwide for CEN national Members.

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SIST EN ISO 8536-9:2005
EN ISO 8536-9:2004 (E)


Foreword

This document (EN ISO 8536-9:2004) 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 June 2005, and conflicting national standards
shall be withdrawn at the latest by June 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 8536-9:2004 has been approved by CEN as EN ISO 8536-9:2004 without any
modifications.
2

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SIST EN ISO 8536-9:2005
INTERNATIONAL ISO
STANDARD 8536-9
First edition
2004-10-01
Infusion equipment for medical use —
Part 9:
Fluid lines for use with pressure infusion
equipment
Matériel de perfusion à usage médical —
Partie 9: Tubulures pour utilisation avec des appareils de perfusion sous
pression

Reference number
ISO 8536-9:2004(E)
©
ISO 2004

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SIST EN ISO 8536-9:2005
ISO 8536-9:2004(E)
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©
ii ISO 2004 – All rights reserved

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SIST EN ISO 8536-9:2005
ISO 8536-9:2004(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Designation . 2
4 Materials . 2
5 Physical requirements . 2
5.1 Transparency . 2
5.2 Particulate contamination . 2
5.3 Tensile strength . 2
5.4 Leakage . 2
5.5 Adapters with female and/or male conical fittings . 2
5.6 Accessories . 2
5.7 Filters . 3
5.8 Storage volume . 3
5.9 Injection needles . 3
5.10 Protective caps . 3
6 Chemical requirements . 3
7 Biological requirements . 3
7.1 Sterility . 3
7.2 Pyrogens . 3
7.3 Haemolysis . 3
8 Packaging . 3
9 Labelling . 4
9.1 Unit container . 4
9.2 Shelf or multi-unit container . 4
Annex A (normative) Physical tests . 5
Annex B (normative) Chemical tests . 6
Annex C (normative) Biological tests . 7
Bibliography . 8
©
ISO 2004 – All rights reserved iii

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SIST EN ISO 8536-9:2005
ISO 8536-9:2004(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 8536-9 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for
medical and pharmaceutical use.
ISO 8536 consists of the following parts, under the general title Infusion equipment for medical use:
— Part 1: Infusion glass bottles
— Part 2: Closures for infusion bottles
— Part 3: Aluminium caps for infusion bottles
— Part 4: Infusion sets for single use, grav
...