SIST EN ISO 8536-5:2012

Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2004)

ISO 8536-5:2004 specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment.  ISO 8536-5:2004 also provides guidance on specifications relating to the quality and performance of materials.  In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-5:2004.

Infusionsgeräte zur medizinischen Verwendung - Teil 5: Infusionsgeräte mit Dosierbehälter für Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-5:2004)

Dieser Teil von ISO 8536 legt Anforderungen für Typen von Infusionsgeräten der Nennvolumen 50 ml, 100 ml und 150 ml mit Dosierbehälter für Schwer¬kraftinfusionen zur einmaligen Verwendung zur medizinischen Verwendung fest, um die Kompatibilität mit Behältern für Infusionslösungen und intravenösen Zugangsmitteln sicherzustellen.
Dieser Teil von ISO 8536 liefert auch eine Anleitung zu Festlegungen hinsichtlich der Qualität und Leistungs-fähigkeit der in Infusionsgeräten verwendeten Werkstoffe.
ANMERKUNG   In einigen Ländern sind das nationale Arzneibuch oder sonstige nationale Bestimmungen gesetzlich bindend und haben Vorrang vor diesem Teil von ISO 8536.

Matériel de perfusion à usage médical - Partie 5: Appareils non réutilisables de perfusion à burette, à alimentation par gravité (ISO 8536-5:2004)

L'ISO 8536-5:2004 spécifie les exigences applicables aux appareils non réutilisables de perfusion à burette, à alimentation par gravité, d'une capacité nominale de 50 ml, 100 ml et 150 ml, à usage médical, afin d'assurer la compatibilité d'emploi entre les récipients pour les solutions de perfusion et les appareils intraveineux.
L'ISO 8536-5:2004 donne également des lignes directrices sur les spécifications relatives à la qualité et aux performances des matériaux utilisés dans les appareils de perfusion.

Infuzijska oprema za uporabo v medicini - 5. del: Infuzijski seti z dozirnikom za primere težje infuzije za enkratno uporabo, delujoči na osnovi gravitacije (ISO 8536-5:2004)

Ta del standarda ISO 8536 določa zahteve za infuzijske sete z dozirnikom za primere težje infuzije za enkratno uporabo, delujoče na osnovi gravitacije, z nominalno kapaciteto 50 ml, 100 ml in 150 ml za uporabo v medicini za zagotavljanje združljivosti z vsebniki za infuzijske raztopine in intravenozno opremo. Ta del standarda ISO 8536 prav tako ponuja napotke glede specifikacij v zvezi s kakovostjo in lastnostmi materialov za infuzijske sete.

General Information

• Status: Withdrawn
• Public Enquiry End Date: 14-Aug-2011
• Publication Date: 15-Dec-2011
• Withdrawal Date: 17-Apr-2013
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 12-Apr-2013
• Due Date: 05-May-2013
• Completion Date: 18-Apr-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: EN ISO 8536-5:2011 - Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2004)

Relations

• Replaced By: SIST EN ISO 8536-5:2013 - Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2004)
• Effective Date: 01-May-2013

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8536-5:2012
01-februar-2012
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO,QIX]LMVNLVHWL]GR]LUQLNRP]D
SULPHUHWHåMHLQIX]LMH]DHQNUDWQRXSRUDERGHOXMRþLQDRVQRYLJUDYLWDFLMH,62

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 8536-5:2011
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-5:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8536-5:2012

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SIST EN ISO 8536-5:2012


EUROPEAN STANDARD
EN ISO 8536-5

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2011
ICS 11.040.20
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 15 October 2011.

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, 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
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-5:2011: E
worldwide for CEN national Members.

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SIST EN ISO 8536-5:2012
EN ISO 8536-5:2011 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EC Directive 93/42/EEC on medical devices .4

2

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SIST EN ISO 8536-5:2012
EN ISO 8536-5:2011 (E)
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 8536-5:2011 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 May 2012, and conflicting national standards shall be withdrawn at the
latest by May 2012.
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 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, 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 8536-5:2004 has been approved by CEN as a EN ISO 8536-5:2011 without any modification.
3

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SIST EN ISO 8536-5:2012
EN ISO 8536-5:2011 (E)
Annex ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EC 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)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
3.2 7.2, 8.1



3.3 7.6
4 13.3
5 1, 2, 3
6.1 9.1, 12.7.1
6.2.1 12.8
6.2.2 7.6
6.2.3 7.6
6.3 10
6.4 10
7 7
8 7.1, 7.2, 7.5, 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 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.
 continued
4

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SIST EN ISO 8536-5:2012
EN ISO 8536-5:2011 (E)
Table ZA.1 (continued)
Clause(s)/sub-clause(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.
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.


5

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SIST EN ISO 8536-5:2012

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SIST EN ISO 8536-5:2012

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

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SIST EN ISO 8536-5:2012
ISO 8536-5:2004(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 i
...

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.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)Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2004)11.040.20Transfuzijska, infuzijska in injekcijska opremaTransfusion, infusion and injection equipmentICS:Ta slovenski standard je istoveten z:FprEN ISO 8536-5kSIST FprEN ISO 8536-5:2011en,fr,de01-julij-2011kSIST FprEN ISO 8536-5:2011SLOVENSKI
STANDARD



kSIST FprEN ISO 8536-5:2011



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
FINAL DRAFT
FprEN ISO 8536-5
April 2011 ICS 11.040.20 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 non réutilisables de perfusion à burette, à alimentation par gravité (ISO 8536-5:2004)
Infusionsgeräte zur medizinischen Verwendung - Teil 5: Infusionsgeräte mit Dosierbehälter für Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-5:2004) This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee CEN/TC 205.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. FprEN ISO 8536-5:2011: EkSIST FprEN ISO 8536-5:2011



FprEN ISO 8536-5:2011 (E) 2 Contents Page Foreword .3 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EC Directive 93/42/EEC on medical devices .4
kSIST FprEN ISO 8536-5:2011



FprEN ISO 8536-5:2011 (E) 3 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 FprEN ISO 8536-5:2011 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptance Procedure. 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. Endorsement notice The text of ISO 8536-5:2004 has been approved by CEN as a FprEN ISO 8536-5:2011 without any modification. kSIST FprEN ISO 8536-5:2011



FprEN ISO 8536-5:2011 (E) 4 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EC 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)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 3.2 7.2, 8.1
3.3 7.6
4 13.3
5 1, 2, 3
6.1 9.1, 12.7.1
6.2.1 12.8
6.2.2 7.6
6.2.3 7.6
6.3 10
6.4 10
7 7
8 7.1, 7.2, 7.5, 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 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. 9 13 The part of ER 13.3 a) relating to the authorized representative is not addressed. kSIST FprEN ISO 8536-5:2011



FprEN ISO 8536-5:2011 (E) 5 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 EC Directives may be applicable to the product(s) falling within the scope of this standard.
kSIST FprEN ISO 8536-5:2011



kSIST FprEN ISO 8536-5:2011



Reference numberISO 8536-5:2004(E)© ISO 2004
INTERNATIONAL STANDARD ISO8536-5Second edition2004-02-01Infusion 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
kSIST FprEN ISO 8536-5:2011



ISO 8536-5:2004(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.
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