SIST EN ISO 8536-13:2024
(Main)Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2024)
Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2024)
ISO 8536-13:2016 specifies requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions with fluid contact under gravity feed conditions.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-13:2016.
Infusionsgeräte zur medizinischen Verwendung - Teil 13: Graduierte Durchflussregler zur einmaligen Verwendung mit Flüssigkeitskontakt (ISO 8536-13:2024)
Dieses Dokument legt Anforderungen an nicht sterile, zur einmaligen Verwendung bestimmte graduierte Durchflussregler fest, die als Einzelkomponente in sterilisierten, zur einmaligen Verwendung bestimmten Infusionsgeräten zur Kontrolle des Durchflusses von intravenösen Infusionslösungen mit Flüssigkeitskontakt unter Schwerkraftkonditionen eingesetzt wird.
Matériel de perfusion à usage médical - Partie 13: Régulateurs de débit gradués non réutilisables avec contact à fluide (ISO 8536-13:2024)
ISO 8536-13:2016 spécifie les exigences applicables aux régulateurs de débit gradués non stériles, non réutilisables, utilisés en tant que sous-composants dans les ensembles de perfusion stérilisés non réutilisables pour contrôler le débit des solutions de perfusion intraveineuses avec contact à fluide, à alimentation par gravité.
Dans certains pays, la pharmacopée nationale ou d'autres réglementations nationales présentent un caractère obligatoire et peuvent prévaloir sur l'ISO 8536-13:2016.
Infuzijska oprema za uporabo v medicini - 13. del: Regulatorji graduiranega pretoka za enkratno uporabo pri stiku s tekočino (ISO 8536-13:2024)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2024
Nadomešča:
SIST EN ISO 8536-13:2017
Infuzijska oprema za uporabo v medicini - 13. del: Regulatorji graduiranega
pretoka za enkratno uporabo pri stiku s tekočino (ISO 8536-13:2024)
Infusion equipment for medical use - Part 13: Graduated flow regulators for single use
with fluid contact (ISO 8536-13:2024)
Infusionsgeräte zur medizinischen Verwendung - Teil 13: Graduierte Durchflussregler
zur einmaligen Verwendung mit Flüssigkeitskontakt (ISO 8536-13:2024)
Matériel de perfusion à usage médical - Partie 13: Régulateurs de débit gradués non
réutilisables avec contact à fluide (ISO 8536-13:2024)
Ta slovenski standard je istoveten z: EN ISO 8536-13:2024
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.
EN ISO 8536-13
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2024
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8536-13:2016
English Version
Infusion equipment for medical use - Part 13: Graduated
flow regulators for single use with fluid contact (ISO 8536-
13:2024)
Matériel de perfusion à usage médical - Partie 13: Infusionsgeräte zur medizinischen Verwendung - Teil
Régulateurs de débit gradués non réutilisables avec 13: Graduierte Durchflussregler zur einmaligen
contact à fluide (ISO 8536-13:2024) Verwendung mit Flüssigkeitskontakt (ISO 8536-
13:2024)
This European Standard was approved by CEN on 20 September 2024.
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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-13:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 8536-13:2024) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection, and blood processing 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 March 2025, and conflicting national standards shall
be withdrawn at the latest by March 2025.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 8536-13:2016.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 8536-13:2024 has been approved by CEN as EN ISO 8536-13:2024 without any
modification.
International
Standard
ISO 8536-13
Second edition
Infusion equipment for medical use —
2024-09
Part 13:
Graduated flow regulators for single
use with fluid contact
Matériel de perfusion à usage médical —
Partie 13: Régulateurs de débit gradués non réutilisables avec
contact à fluide
Reference number
ISO 8536-13:2024(en) © ISO 2024
ISO 8536-13:2024(en)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 8536-13:2024(en)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Design . 2
5 Materials . 2
6 Physical requirements . 2
6.1 Graduated scale . .2
6.2 Particulate contamination .2
6.3 Tensile strength .3
6.4 Leakage .3
6.5 Flow rates .3
7 Chemical requirements . 3
Annex A (normative) Physical tests . . 4
Bibliography . 6
iii
ISO 8536-13:2024(en)
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.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and blood
processing equipment for medical and pharmaceutical use, in collaboration with the European Committee for
Standardization (CEN) Technical Committee CEN/TC 205, Non-active medical devices, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 8536-13:2016), which has been technically
revised.
The main changes are as follows:
— in Clause 3, the new term “activation” has been added;
— Figure 1 in Clause 4 has been amended to include markings on the open and close positions;
— former Clause 8 “Biological requirements” has been deleted due to the specified product being non-
sterile;
— Annex A has been amended by a general introduction (see A.1) on the pre-conditioning of the sample;
— Annex A.5 has been amended to align the flow rate test method with other flow rate test methods in the
ISO 8536 series;
— the Bibliography has been updated.
A list of all parts in the ISO 8536 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
International Standard ISO 8536-13:2024(en)
Infusion equipment for medical use —
Part 13:
Graduated flow regulators for single use with fluid contact
1 Scope
This document specifies requirements for non-sterile, single-use graduated flow regulators used as
subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions
with fluid contact under gravity feed conditions.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 8536-4, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 80000-4, Quantities and units — Part 4: Mechanics
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology database
...
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