EN ISO 8536-4:2007
(Main)Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2007)
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2007)
This part of ISO 8536 specifies requirements for single-use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.
Secondary aims of this part of ISO 8536 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.
Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2007)
Matériel de perfusion à usage médical - Partie 4: Appareils de perfusion non réutilisables, à alimentation par gravité (ISO 8536-4:2007)
Infuzijska oprema za uporabo v medicini – 4. del: Infuzijski seti za enkratno uporabo, delujoči na osnovi gravitacije (ISO 8536-4:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2007
1DGRPHãþD
SIST EN ISO 8536-4:2005
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQL±GHO ,QIX]LMVNLVHWL]DHQNUDWQR
XSRUDERGHOXMRþLQDRVQRYLJUDYLWDFLMH ,62
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
(ISO 8536-4:2007)
Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für
Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2007)
Matériel de perfusion a usage médical - Partie 4: Appareils de perfusion non
réutilisables, a alimentation par gravité (ISO 8536-4:2007)
Ta slovenski standard je istoveten z: EN ISO 8536-4:2007
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
April 2007
ICS 11.040.20 Supersedes EN ISO 8536-4:2004
English Version
Infusion equipment for medical use - Part 4: Infusion sets for
single use, gravity feed (ISO 8536-4:2007)
Matériel de perfusion à usage médical - Partie 4: Appareils Einführendes Element - Haupt-Element - Teil 4:
de perfusion non réutilisables, à alimentation par gravité Ergänzendes Element (ISO 8536-4:2007)
(ISO 8536-4:2007)
This European Standard was approved by CEN on 15 March 2007.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, 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
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-4:2007: E
worldwide for CEN national Members.
Foreword
This document (EN ISO 8536-4:2007) 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 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 October 2007, and conflicting national
standards shall be withdrawn at the latest by October 2007.
This document supersedes EN ISO 8536-4:2004.
This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU
Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.
Endorsement notice
The text of ISO 8536-4:2007 has been approved by CEN as EN ISO 8536-4:2007 without any
modifications.
Annex ZA
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices
This International Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide one means of conforming to
Essential Requirements of the New Approach Directive 93/42/EEC on Medical devices.
Once this standard is cited in the Official Journal of the European Communities under that
Directive and has been implemented as a national standard in at least one Member State,
compliance with the clauses of this standard given in Table ZA confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding Essential
Requirements of that Directive and associated EFTA regulations.
Table ZA — Correspondence between this International Standard and Directive
93/42/EEC, Medical devices
Clause(s)/Sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/Notes
this International Standard EU Directive 93/42/EEC
3.2 8.1
4 13.3
5 1, 2, 3
6.1 7.2
6.3 9.1
6.4 7.6
6.5 7.6
6.6 12.8
6.8 12.8
6.9 10, 12.8
6.10 10, 12.8
6.11 8
6.12 9.1
6.13 8
7 7
8 7, 7.5
8.2 8.3
8.3 7.1
8.4 7.1
8.5 7.1
9 13
10 8
WARNING: Other requirements and other EU Directives may be applicable to the products
falling within the scope of this standard.
INTERNATIONAL ISO
STANDARD 8536-4
Fourth edition
2007-04-01
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 8536-4:2007(E)
©
ISO 2007
ISO 8536-4:2007(E)
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ISO 8536-4:2007(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 8536-4:2007(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 ha
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