oSIST prEN ISO 8536-5:2025

SLOVENSKI STANDARD
01-december-2025
Infuzijska oprema za uporabo v medicini - 5. del: Infuzijski seti z dozirnikom za
primere težje infuzije za enkratno uporabo, delujoči na osnovi gravitacije (ISO/DIS
8536-5:2025)
Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity
feed (ISO/DIS 8536-5:2025)
Infusionsgeräte zur medizinischen Verwendung - Teil 5: Infusionsgeräte mit
Dosierbehälter für Schwerkraftinfusionen zur einmaligen Verwendung (ISO/DIS 8536-
5:2025)
Matériel de perfusion à usage médical - Partie 5: Appareils non réutilisables de perfusion
à burette, à alimentation par gravité (ISO/DIS 8536-5:2025)
Ta slovenski standard je istoveten z: prEN ISO 8536-5
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.

DRAFT
International
Standard
ISO/DIS 8536-5
ISO/TC 76
Infusion equipment for medical
Secretariat: DIN
use —
Voting begins on:
Part 5: 2025-10-16
Burette infusion sets for single use,
Voting terminates on:
2026-01-08
gravity feed
Matériel de perfusion à usage médical —
Partie 5: Appareils non réutilisables de perfusion à burette, à
alimentation par gravité
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 has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
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USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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 8536-5:2025(en)
DRAFT
ISO/DIS 8536-5:2025(en)
International
Standard
ISO/DIS 8536-5
ISO/TC 76
Infusion equipment for medical use —
Secretariat: DIN
Part 5:
Voting begins on:
Burette infusion sets for single use,
gravity feed
Voting terminates on:
Matériel de perfusion à usage médical —
Partie 5: Appareils non réutilisables de perfusion à burette, à
alimentation par gravité
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 has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
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
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
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.
ISO copyright office
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 8536-5:2025(en)
ii
ISO/DIS 8536-5:2025(en)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
4.1 Design .2
4.2 Graduated scale . .3
4.3 Numbering of scales .5
4.4 Overall length of scale to nominal capacity line .5
4.5 Variation of scale .5
5 Materials . 5
6 Physical requirements . 5
6.1 Particulate contamination .5
6.2 Tensile strength .5
6.3 Leakage .5
6.4 Air-inlet device .5
6.5 Fluid filter / filter for blood and blood components .6
6.6 Drip chamber and drip tube .6
7 Chemical requirements . 6
8 Biological requirements . 6
Annex A (normative) Physical tests . . 7
Annex B (informative) Rationale, guidance and history of development the standard . 8
Annex C (informative) Sustainability Aspects . 10
Bibliography .11

iii
ISO/DIS 8536-5:2025(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 document 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.
This third edition cancels and replaces the second edition (ISO 8536-5:2004), which has been technically
revised.
The main changes are as follows:
— a change of scope to consider burettes as components of infusion sets;
— a scope expansion to include additional applications of burettes in transfusion applications;
— additional or revised clauses concerning light-resistance, the graduated scale, particulate contamination,
air-inlet, leakage, and drop former requirements;
— removal of clauses concerning labelling, packaging, and disposal;
— addition of Annexes A, B, and C.
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
DRAFT International Standard ISO/DIS 8536-5:2025(en)
Infusion equipment for medical use —
Part 5:
Burette infusion sets for single use, gravity feed
1 Scope
This document specifies requirements for single-use burettes to be used as subcomponents within sterilised
infusion and transfusion sets for single use under gravity feed conditions or with pressure infusion
apparatus.
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.
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
ISO 1135-4, Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
ISO 8536-4, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
ISO 8536-8, Infusion equipment for medical use — Part 8: Infusion sets for single use with pressure infusion
apparatus
ISO 8536-15, Infusion equipment for medical use — Part 15: Light-protective infusion sets for single use
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 24072, Aerosol bacterial retention test method for air-inlet filter on administration devices
3 Terms and definitions
No terms and definitions are listed in this document.
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 Electropedia: available at https:// www .electropedia .org/

ISO/DIS 8536-5:2025(en)
4 General requirements
4.1 Design
4.1.1 A typical design along with the nomenclature to be used for burettes is given in Figure 1.
Key
a
1 injection site
2 air inlet with air filter and closure
3 graduated burette
a
4 shut-off valve
5 drip tube
6 drip chamber
b c
7 fluid filter / filter for blood and blood components
a
Optional.
b
The fluid filter may be positioned at other sites, for example preferably near the patient access. Generally a
fluid filter has a nominal pore size of 15 µm.
c
Indicates alternative locations of the filter for blood and blood components. Other designs are acceptable, if
the same safety aspects are ensured.
Figure 1 — Example of a burette

ISO/DIS 8536-5:2025(en)
4.1.2 The burette shall consist of a tube of rigid or semi-rigid plastics material and shall permit observation
of fluid in the chamber.
4.1.3 The burette shall be provided with filtered air-venting capability located in a position above the top
graduation mark.
4.1.4 The burette shall be capable of receiving fluid from the main container (or from the injection site /
LAV as applicable) and of being closed off and serving as a separate self-vented reservoir.
4.1.5 For burettes that claim light protection, the requirements for drip chambers specified in ISO 8536-15
shall apply to the graduated burette which is denoted as item 3 in Figure 1.
4.1.6 The nominal volume of the burette shall be designated by the total graduated capacity.
4.2 Graduated scale
4.2.1 The burette shall have either only one scale or more than one identical scale, which shall be graduated
and numbered at least at the intervals given in Table 1. The unit of volume shall be marked on the burette.
NOTE The scale interval can be less (finer) than the scale interval given in Table 1.
4.2.2 The total graduated capacity may be equal to, or greater than, the nominal capacity. If the scale is
extended beyond the nominal capacity, the extended portion shall be differentiated from the rest of the scale.
Examples of means of differentiation are the following:
a) encircling the scale number of the nominal capacity line;
b) using smaller scale numbers for the extra graduation lines;
c) using shorter graduation lines for the extra graduation lines;
d) using a broken line for the optional vertical line of the extra scale length.
4.2.3 Graduation lines shall be of uniform thickness. They shall lie in planes at right angles to the axis of
the burette.
4.2.4 Graduation lines shall be evenly spaced along the longitudinal axis between the zero graduation line
and the line for the total graduated capacity.
4.2.5 When the burette is held vertically, the ends of all graduation lin
...