EN ISO 8536-4:2004

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2004)

Specifies dimensions and performance of single use devices for use in giving infusions to the vascular systems of humans.

Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2004)

Dieser Teil von ISO 8536 legt Anforderungen an zur einmaligen Verwendung bestimmte medizinische Infusionsgeräte für Schwerkraftinfusionen fest, um sicherzustellen, dass sie zur Verwendung mit Behältern für Infusionslösungen und Geräten zur intravenösen Punktion geeignet sind.
Sekundäres Ziel dieses Teils von ISO 8536 ist eine Anleitung zu Festlegungen bezüglich Qualität und Leistungsfähigkeit der Werkstoffe, die für Infusionsgeräte verwendet werden. Außerdem werden Benennungen für die Einzelteile von Infusionsgeräten angegeben.
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 4: Appareils de perfusion non réutilisables, à alimentation par gravité (ISO 8536-4:2004)

NEW!IEC 60287-3-1:2017 est disponible sous forme de IEC 60287-3-1:2017 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.

L'IEC 60287-3:2017 s'applique aux conditions de fonctionnement en régime permanent des câbles de toutes tensions enterrés directement dans le sol, placés dans des fourreaux, caniveaux ou tubes d'acier, avec ou sans assèchement partiel du sol, ainsi que les câbles posés à l'air libre. On entend par «régime permanent» la circulation continue d'un courant constant (facteur de charge 100 %) assez suffisant pour produire asymptotiquement la température maximale à l'âme en supposant que les conditions du milieu ambiant restent constantes. Le présent document définit les conditions du site de référence, cependant les valeurs générales sont remplacées par les exigences spécifiques nationales. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
- la liste mise à jour des conditions de pose nationales est maintenant couverte par l'Annexe A;
- l'Article 5 relatif aux informations exigées de l'acheteur pour permettre la sélection du type approprié de câble a été supprimé.

Infuzijska oprema za uporabo v medicini – 4. del: Infuzijski seti za enkratno uporabo, delujoči na osnovi gravitacije (ISO 8536-4:2004)

General Information

• Status: Withdrawn
• Publication Date: 14-Aug-2004
• Withdrawal Date: 31-Mar-2007
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 11 - Transfusion, infusion and injection equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-Apr-2007
• Completion Date: 01-Apr-2007
• Ref Project: SIST EN ISO 8536-4:2005 - Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2004)

Relations

• Replaced By: EN ISO 8536-4:2007 - Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2007)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2005
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQL±GHO,QIX]LMVNLVHWL]DHQNUDWQR
XSRUDERGHOXMRþLQDRVQRYLJUDYLWDFLMH,62
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
(ISO 8536-4:2004)
Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für
Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2004)
Matériel de perfusion a usage médical - Partie 4: Appareils de perfusion non
réutilisables, a alimentation par gravité (ISO 8536-4:2004)
Ta slovenski standard je istoveten z: EN ISO 8536-4:2004
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 8536-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2004
ICS 11.040.20
English version
Infusion equipment for medical use - Part 4: Infusion sets for
single use, gravity feed (ISO 8536-4:2004)
Matériel de perfusion à usage médical - Partie 4: Appareils Infusionsgeräte zur medizinischen Verwendung - Teil 4:
de perfusion non réutilisables, à alimentation par gravité Infusionsgeräte für Schwerkraftinfusionen zur einmaligen
(ISO 8536-4:2004) Verwendung (ISO 8536-4:2004)
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 8536-4:2004: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 8536-4:2004) 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 8536-4:2004 has been approved by CEN as EN ISO 8536-4:2004 without any
modifications.
INTERNATIONAL ISO
STANDARD 8536-4
Third edition
2004-08-15
Infusion equipment for medical use —
Part 4:
Infusion sets for single use, gravity feed
Matériel de perfusion à usage médical —
Partie 4: Appareils de perfusion non réutilisables, à alimentation par
gravité
Reference number
ISO 8536-4:2004(E)
©
ISO 2004
ISO 8536-4:2004(E)
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ii © ISO 2004 – All rights reserved

ISO 8536-4:2004(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 Leakage. 5
6.3 Tensile strength. 5
6.4 Closure-piercing device. 5
6.5 Air-inlet device. 5
6.6 Tubing. 6
6.7 Fluid filter. 6
6.8 Drip chamber and drip tube . 6
6.9 Flow regulator. 6
6.10 Flow rate of infusion fluid . 6
6.11 Injection site. 6
6.12 Male conical fitting. 6
6.13 Protective caps. 6
7 Chemical requirements. 7
7.1 Reducing (oxidizable) matter. 7
7.2 Metal ions. 7
7.3 Titration acidity or alkalinity . 7
7.4 Residue on evaporation. 7
7.5 UV absorption of extract solution . 7
8 Biological requirements. 7
8.1 General. 7
8.2 Sterility. 7
8.3 Pyrogenicity. 7
8.4 Haemolysis. 7
8.5 Toxicity. 8
9 Labelling. 8
9.1 Unit container. 8
9.2 Shelf or multi-unit container . 8
10 Packaging. 9
Annex A (normative) Physical tests . 10
Annex B (normative) Chemical tests. 14
Annex C (normative) Biological tests. 16
Bibliography . 17

ISO 8536-4:2004(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 8536-4 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
This third edition cancels and replaces the second edition (ISO 8536-4:1998) which has been technically
revised.
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, gravity feed
 Part 5: Burette infusion sets for single use, gravity feed
 Part 6: Freeze drying closures for infusion bottles
 Part 7: Caps made of aluminium-plastics combinations for infusion bottles
 Part 8: Infusion equipment for use with pressure infusion apparatus
 Part 9: Fluid lines for use with pressure infusion equipment
 Part 10: Accessories for fluid lines for use with pressure infusion equipment
 Part 11: Infusion filters for use with pressure infusion equipment

iv © ISO 2004 –
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