SIST EN ISO 8536-8:2005

Infusion equipment for medical use - Part 8: Infusion equipment for use with pressure infusion apparatus (ISO 8536-8:2004)

Applies exclusively to sterilised infusion equipment for single use for use with pressure infusion apparatus 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 a 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

• Status: Withdrawn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 8536-8:2004 - Infusion equipment for medical use - Part 8: Infusion equipment for use with pressure infusion apparatus (ISO 8536-8:2004)

Relations

• Replaced By: 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)
• Effective Date: 01-Sep-2015
• Replaced By: 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)
• Effective Date: 08-Jun-2022

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.

---------------------- Page: 1 ----------------------

SIST EN ISO 8536-8:2005

---------------------- Page: 2 ----------------------

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.

---------------------- Page: 3 ----------------------

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

---------------------- Page: 4 ----------------------

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

---------------------- Page: 5 ----------------------

SIST EN ISO 8536-8:2005
ISO 8536-8:2004(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.


©  ISO 2004
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland

ii © ISO 2004 – All rights reserved

---------------------- Page: 6 ----------------------

SIST EN ISO 8536-8:2005
ISO 8536-8:2004(E)
Contents Page
Foreword. iv
1 Scope. 1
2 Normative references. 1
3 General requirements. 1
4 Designation. 4
4.1 Infusion set. 4
4.2 Air-inlet device. 4
5 Materials. 4
6 Physical requirements. 5
6.1 Particulate contamination. 5
6.2 Tensile strength. 5
6.3 Leakage. 5
6.4 Male conical fitting. 5
6.5 Injection site. 5
6.6 Fluid filter. 5
6.7 Flow rate of infusion fluid . 5
6.8 Closure-piercing device. 5
6.9 Air-inlet device. 5
6.10 Drip chamber and drip tube . 5
6.11 Tubing. 5
6.12 Flow regulator. 5
6.13 Protective caps. 6
6.14 Storage volume. 6
7 Chemical requirements. 6
8 Biological requirements. 6
9 Packaging. 6
10 Labelling. 6
10.1 Unit container. 6
10.2 Shelf or multi-unit container . 7
Annex A (normative) Physical tests . 8
Annex B (normative) Chemical tests.9
Annex C (normative) Biological tests. 10
Bibliography . 11

© ISO 2004 – All rights reserved iii

---------------------- Page: 7 ----------------------

SIST EN ISO 8536-8:2005
ISO 8536-8:2004(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 8536-8 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
...