EN ISO 8536-4:2010

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010)

ISO 8536‑4:2010 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 ISO 8536‑4:2010 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 ISO 8536‑4:2010.

Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2010)

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 Benennun-gen 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 8536-4:2010)

L'ISO 8536-4:2010 spécifie les exigences applicables aux appareils de perfusion à usage médical, non réutilisables, à alimentation par gravité, afin d'assurer leur compatibilité avec les récipients contenant des solutions de perfusion et avec les appareils intraveineux.
Le deuxième objectif de l'ISO 8536-4:2010 est de donner des directives sur les spécifications relatives à la qualité et aux performances des matériaux utilisés dans les appareils de perfusion et de proposer une terminologie concernant les composants de ces derniers.
Dans certains pays, la pharmacopée nationale ou d'autres règlements nationaux ont force d'obligation et ont priorité sur l'ISO 8536-4:2010.

Infuzijska oprema za uporabo v medicini - 4. del: Infuzijski seti za enkratno uporabo, delujoči na osnovi gravitacije (ISO 8536-4:2010)

Ta del ISO 8536 določa zahteve za infuzijske sete za enkratno uporabo, delujoče na osnovi gravitacije, za uporabo v medicini z namenom zagotoviti skladnost s posodami za raztopine za infundiranje in z intravenozno opremo.  Drugotni cilji tega dela ISO 8536 so zagotoviti napotke glede specifikacij, ki se nanašajo na kakovost in delovanje materialov, kateri se uporabljajo v transfuzijskih setih, ter predstaviti oznake za sestavne dele infuzijskih setov.  V nekaterih državah so farmakopeja države ali drugi predpisi države pravno zavezujoči in imajo prednost pred tem delom ISO 8536.

General Information

• Status: Withdrawn
• Publication Date: 30-Sep-2010
• Withdrawal Date: 05-Feb-2013
• 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: 9960 - Withdrawal effective - Withdrawal
• Start Date: 06-Feb-2013
• Completion Date: 06-Feb-2013
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 8536-4:2010 - Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010)

Relations

• Replaces: 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: 09-Oct-2010
• Replaced By: EN ISO 8536-4:2013 - Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010)
• Effective Date: 30-Jan-2013

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2010
1DGRPHãþD
SIST EN ISO 8536-4:2007
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO,QIX]LMVNLVHWL]DHQNUDWQR
XSRUDERGHOXMRþLQDRVQRYLJUDYLWDFLMH,62
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
(ISO 8536-4:2010)
Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für
Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2010)
Matériel de perfusion à usage médical - Partie 4: Appareils de perfusion non
réutilisables, à alimentation par gravité (ISO 8536-4:2010)
Ta slovenski standard je istoveten z: EN ISO 8536-4:2010
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
October 2010
ICS 11.040.20 Supersedes EN ISO 8536-4:2007
English Version
Infusion equipment for medical use - Part 4: Infusion sets for
single use, gravity feed (ISO 8536-4:2010)
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 8536-4:2010) Verwendung (ISO 8536-4:2010)
This European Standard was approved by CEN on 14 September 2010.

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, Croatia, 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: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-4:2010: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA .4

Foreword
The text of ISO 8536-4:2010 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion
and injection equipment for medical and pharmaceutical use” of the International Organization for
Standardization (ISO) and has been taken over as EN ISO 8536-4:2010 by 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 April 2011, and conflicting national standards shall be withdrawn at the
latest by April 2011.
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 8536-4:2007.
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.
For relationship with EU Directive, 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, Croatia, 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 the United Kingdom.
Endorsement notice
The text of ISO 8536-4:2010 has been approved by CEN as a EN ISO 8536-4:2010 without any modification.
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 a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC, Medical devices.
Once this standard is cited in the Official Journal of the European Union 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.1 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.1 — Correspondence between this International Standard and Directive 93/42/EEC, Medical
devices
Clause(s)/subclause(s) of this Essential Requirements (ERs) of
Qualifying remarks/Notes
International Standard Directive 93/42/EEC
3.2 8.1
4 13.3
5 1, 2, 3
6.1 7.2
6.2 7.6
6.3 9.1, 12.7.1
6.4 7.6
6.5 7.6
6.6 12.8
6.7 7.2
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
8.1 7, 7.5 Presumption of conformity with the
Essential Requirements relating to
the biological evaluation can only
be provided if the manufacturer
chooses to apply the ISO 10993
series of standards.
8.2 8.4
8.3 7.1, 7.2
8.4 7.1, 7.2
8.5 7.1, 7.2
9 13 The part of ER 13.3 a) relating to
the authorized representative is
not addressed.
ERs 13.3 f) and 13.6 h) relating to
single-use are not fully addressed.
ER 13.6 q) is not addressed.
10 5, 8.3
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 8536-4
Fifth edition
2010-10-01
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 8536-4:2010(E)
©
ISO 2010
ISO 8536-4:2010(E)
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ISO 8536-4:2010(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 .
...