SIST EN ISO 8536-5:2013

SLOVENSKI STANDARD
01-maj-2013
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Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity
feed (ISO 8536-5:2004)
Infusionsgeräte zur medizinischen Verwendung - Teil 5: Infusionsgeräte mit
Dosierbehälter für Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-5:2004)
Matériel de perfusion à usage médical - Partie 5: Appareils non réutilisables de perfusion
à burette, à alimentation par gravité (ISO 8536-5:2004)
Ta slovenski standard je istoveten z: EN ISO 8536-5:2013
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 8536-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2013
ICS 11.040.20 Supersedes EN ISO 8536-5:2011
English Version
Infusion equipment for medical use - Part 5: Burette infusion
sets for single use, gravity feed (ISO 8536-5:2004)
Matériel de perfusion à usage médical - Partie 5: Appareils Infusionsgeräte zur medizinischen Verwendung - Teil 5:
non réutilisables de perfusion à burette, à alimentation par Infusionsgeräte mit Dosierbehälter für
gravité (ISO 8536-5:2004) Schwerkraftinfusionen zur einmaligen Verwendung (ISO
8536-5:2004)
This European Standard was approved by CEN on 8 January 2013.

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-CENELEC 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-CENELEC 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-5:2013: E
worldwide for CEN national Members.

Contents
Page
Foreword . 3
Annex ZA (informative)  Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices . 4

Foreword
The text of ISO 8536-5:2004 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion
and injection, and blood processing equipment for medical and pharmaceutical use” of the International
Organization for Standardization (ISO) and has been taken over as EN ISO 8536-5:2013 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 August 2013, and conflicting national standards shall be withdrawn at
the latest by August 2013.
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 8536-5:2011.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 8536-5:2004 has been approved by CEN as EN ISO 8536-5:2013 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices
This European 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 on 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 European Standard
and Directive 93/42/EEC on medical devices
Clause(s)/subclause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
3.2, 8 7.2
8 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 EN ISO 10993 series
of standards. However, the part
of ER 7.5 relating to phthalates
is not specifically addressed in
the EN ISO 10993 series.
3.3, 6.2.2, 6.2.3 7.6
3.2 8.1
10 8.3
8 8.4 Presumption of conformity with
the Essential Requirements
relating to the biological
evaluation can only be provided
if the manufacturer chooses to
apply the EN ISO 10993 series
of standards. However, the part
of ER 7.5 relating to phthalates
is not specifically addressed in
the EN ISO 10993 series.
6.1 9.1
6.3, 6.4 10
6.1 12.7.1
6.2.1 12.8
Clause(s)/subclause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
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.
4 13.3
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.

INTERNATIONAL ISO
STANDARD 8536-5
Second edition
2004-02-01
Infusion equipment for medical use —
Part 5:
Burette infusion sets for single use,
gravity feed
Matériel de perfusion à usage médical —
Partie 5: Appareils non réutilisables de perfusion à burette, à
alimentation par gravité
Reference number
ISO 8536-5:2004(E)
©
ISO 2004
ISO 8536-5:2004(E)
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