ISO/FDIS 8536-5

ISO/DISFDIS 8536-5:2026(en)
ISO/TC 76
Secretariat: DIN
Date: 2026-07-0108-20
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
FDIS stage
TTTTTThhhhhhiiiiiissssss d d d d d drrrrrraftaftaftaftaftaft i i i i i issssss s s s s s suuuuuubbbbbbmmmmmmiiiiiittttttttttttedededededed t t t t t toooooo   a pa pa pa pa pa pararararararallel vallel vallel vallel vallel vallel vooooootttttte e e e e e iiiiiinnnnnn I I I I I ISSSSSSOOOOOO,,,,,, C C C C C CEEEEEENNNNNN.

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
EmailE-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
Contents
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 . 4
4.3 Numbering of scales . 7
4.4 Overall length of scale to nominal capacity line . 7
4.5 Variation of scale. 7
5 Materials . 8
6 Physical requirements . 8
6.1 Particulate contamination . 8
6.2 Tensile strength . 8
6.3 Leakage . 8
6.4 Air-inlet device . 8
6.5 Fluid filter/filter for blood and blood components . 8
6.6 Drip chamber and drip tube . 8
7 Chemical requirements . 9
8 Biological requirements . 9
Annex A (normative) Test method for burette scale graduation accuracy . 10
Annex B (informative) Rationale, guidance and history of the development of this document . 11
Annex C (informative) Sustainability. 14
Annex D (informative) Attributive and variable testing . 16
Bibliography . 17

iii
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;
— — additionaladdition or revisedrevision of 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, BAnnexes A, B,, and CC.
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
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.
NOTE 1 Annex BAnnex B provides explanations about the history of the development of the standard and summarises
the different arguments discussed within ISO/TC 76 during the collaboration of this document.
NOTE 2 Annex CAnnex C provides recommendations regarding sustainability.
NOTE 3 Annex DAnnex D provides information on attributive and variable testing.
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--10, Infusion equipment for medical use — Part 10: Accessories for fluid lines for single use with
pressure infusion equipment
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: EvaluationRequirements and testinggeneral
principles for the evaluation of biological safety 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
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical 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/
4 General requirements
4.1 Design
4.1.1 4.1.1 A typical design along with the nomenclature to be used for burettes is given in
Figure 1Figure 1.
Key
a
1 injection site
2 air inlet with air filter and closure
3 graduated burette
4 shut-off valve
5 drip tube
6 drip chamber
7 fluid filter / /filter for blood and blood components
a
Optional.
b
See ISO 8536-4 for fluid filter requirements.
c
See ISO 1135-4 for blood filter requirements.
Figure 1 — Example of a burette
4.1.2 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 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 4.1.4 The burette shall be capable of receiving fluid from the main container (or from the injection
site / /Luer activated valve (LAV) as applicable) and of being closed off and serving as a separate self-vented
reservoir.
4.1.5 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 and attached drip chamber which is denoted as items 3 and
6 in Figure 1Figure 1.
4.1.6 4.1.6 The nominal volume of the burette shall be designated by the total graduated capacity.
4.2 Graduated scale
4.2.1 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 1Table 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 1Table 1.
4.2.2 4.2.2 Graduation lines shall be of uniform thickness. They shall lie in planes at right angles to the axis
of the burette.
4.2.3 4.2.3 Graduation lines shall be evenly spaced along the longitudinal axis between the zero
graduation line and the line for the total graduated capacity.
4.2.4 4.2.4 When the burette is held vertically, the ends of all graduation lines of similar length shall be
vertically beneath each other.
The lengths of the short graduation lines on each scale are recommended to be approximately half the length
of the long lines. If different graduation line configurations are used, this shall be submitted to usability
evaluation according toin accordance with IEC 62366-1.
Examples of scales and the numbering of graduation lines are shown in Figure 2Figure 2.
4.2.5 4.2.5 The zero-position mark on the burette shall be located in a position which compensates for the
volume displaced by any shut-off device, the position of the outlet relative to the bottom of the burette, or any
other feature of the bottom cap which can affect the reading.
4.2.6 4.2.6 The accuracy of the scale shall be tested in accordance with Annex AAnnex A and shall meet
the accuracy requirements of Table 1Table 1.
Table 1 — Volume and scale intervals for burettes
Tolerance on any graduated capacity
Minimum
Less than
overall Increment
half and
Nominal length of between
Less than Equal to or
Scale
more than
capacity of scale to graduation
20 % greater than
interval
or equal to
burette nominal lines to be
nominal half nominal
20 %
capacity numbered
capacity capacity
nominal
mark
capacity
V
ml    mm ml ml
±5 % of
±(1,5 % of V +1 % of expelled
V < 50 expelled 67 2,0 10
volume)
volume
±5 % of
±(1,5 % of V +1 % of expelled
V ≥ 50 expelled 75 5,0 10
volume)
volume
NOTE Expelled volume means all the liquid ejected to the point where the meniscus of the water level is coincident
with the zero mark of the scale.
NOTE The vertical lines are optional.
Figure 2 — Typical graduated scales for use in burettes
4.3 Numbering of scales
4.3.1 4.3.1 Graduation lines shall be numbered at least at the volume of increments given in
Table 1Table 1.
Examples of scale numbering are shown in Figure 2Figure 2.
4.3.2 4.3.2 When the burette is held vertically with the scale to the front, the numbers shall appear vertical
on the scale and be approximately centred on the graduation lines to which they relate. The numbers shall be
close to, but shall not touch, the ends of the graduation lines to which they relate.
4.4 Overall length of scale to nominal capacity line
The overall length of the scale shall be as given in Table 1Table 1.
4.5 Variation of scale
If necessary by a specific application, the scale may vary and this requirement does not preclude the provision
...