EN ISO 8536-16:2025

SLOVENSKI STANDARD
oSIST prEN ISO 8536-16:2024
01-oktober-2024
Infuzijska oprema za uporabo v medicini - 15. del: Infuzijski kompleti za enkratno
uporabo z volumetričnimi infuzijskimi krmilniki (ISO/DIS 8536-16:2024)
Infusion equipment for medical use - Part 16: Infusion sets for single use with volumetric
infusion controllers (ISO/DIS 8536-16:2024)
Infusionsgeräte zur medizinischen Verwendung - Teil 16: Infusionsgeräte mit
volumetrischen Infusionsreglern zur einmaligen Verwendung (ISO/DIS 8536-16:2024)
Matériel de perfusion à usage médical - Partie 16: Appareils de perfusion à usage
unique avec régulateurs de perfusion volumétriques (ISO/DIS 8536-16:2024)
Ta slovenski standard je istoveten z: prEN ISO 8536-16
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 8536-16:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 8536-16:2024
oSIST prEN ISO 8536-16:2024
DRAFT
International
Standard
ISO/DIS 8536-16
ISO/TC 76
Infusion equipment for medical
Secretariat: DIN
use —
Voting begins on:
Part 16: 2024-08-28
Infusion sets for single use with
Voting terminates on:
2024-11-20
volumetric infusion controllers
ICS: 11.040.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
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BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
ISO/DIS 8536-16:2024(en)
oSIST prEN ISO 8536-16:2024
DRAFT
ISO/DIS 8536-16:2024(en)
International
Standard
ISO/DIS 8536-16
ISO/TC 76
Infusion equipment for medical use —
Secretariat: DIN
Part 16:
Voting begins on:
Infusion sets for single use with
volumetric infusion controllers
Voting terminates on:
ICS: 11.040.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
This document is circulated as received from the committee secretariat. BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
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RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 8536-16:2024(en)
ii
oSIST prEN ISO 8536-16:2024
ISO/DIS 8536-16:2024(en)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
5 Materials . 6
6 Physical requirements . 6
6.1 Particulate contamination .6
6.2 Leakage .6
6.3 Tensile resistance . .6
6.4 Flow rate of infusion set .7
6.5 Flow regulator .7
6.6 Closure-piercing device .7
6.7 Air-inlet device .7
6.8 Tubing .7
6.9 Fluid filter .7
6.10 Drip chamber and drip tube .7
6.11 Injection site .7
6.12 Male conical fitting .7
6.13 Protective caps .7
7 Chemical requirements . 7
8 Biological requirements . 7
9 Labelling . 8
9.1 General .8
9.2 Unit container .8
9.3 Shelf or multi-unit container .8
10 Packaging. 9
11 Disposal . 9
Annex A (normative) Physical tests . .10
Bibliography .13

iii
oSIST prEN ISO 8536-16:2024
ISO/DIS 8536-16:2024(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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
rights identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see www.iso.org/patents).
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.
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
oSIST prEN ISO 8536-16:2024
DRAFT International Standard ISO/DIS 8536-16:2024(en)
Infusion equipment for medical use —
Part 16:
Infusion sets for single use with volumetric infusion
controllers
1 Scope
This document specifies the requirements for sterilized, single-use, gravity feed infusion sets used together
[1]
with the volumetric infusion controllers of IEC 60601-2-24 .
Note In some countries, the national pharmacopoeia or other national regulations are legally binding and take
[3-5]
precedence over this document .
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 8536-4, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
ISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by
particle concentration
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part
1: General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC El
...