ISO 8536-5
(Main)Infusion equipment for medical use — Part 5: Burette infusion sets for single use, gravity feed
- Abstract
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.
- Status
- Not Published
- Current Stage
- 6000 - International Standard under publication
- Start Date
- 30-Oct-2026
- Completion Date
- 31-Oct-2026
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ISO/FDIS 8536-5 - Infusion equipment for medical use — Part 5: Burette infusion sets for single use, gravity feed
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ISO/FDIS 8536-5 - Matériel de perfusion à usage médical — Partie 5: Appareils non réutilisables de perfusion à burette, à alimentation par gravité
ISO 8536-5 is an ISO standard for burette infusion sets for single use, gravity feed. It specifies requirements for single-use burettes used as subcomponents in sterilised infusion and transfusion sets, so they work with infusion solution containers and intravenous equipment. The document covers 50 ml, 100 ml and 150 ml nominal capacities and is intended for manufacturers, test laboratories, quality teams and buyers of infusion and transfusion devices.
What does ISO 8536-5 specify?
ISO 8536-5 specifies the requirements for burette infusion sets for single use, including use under gravity feed conditions and with pressure infusion apparatus. In practice, it sets the rules for the burette as a component, not as a finished infusion set, so the burette can be checked for compatibility with the larger device it is built into.
The scope notes that, in some countries, national pharmacopoeia or other national regulations can take legal precedence. The document is organized into clauses on scope, normative references, terms and definitions, general requirements, materials, physical requirements, chemical requirements and biological requirements, followed by four annexes.
| Annex | What it covers |
|---|---|
| Annex A | Test method for burette scale graduation accuracy |
| Annex B | Rationale, guidance and history of development |
| Annex C | Sustainability |
| Annex D | Attributive and variable testing |
What are the key requirements of ISO 8536-5?
ISO 8536-5 focuses on design, scale accuracy, material safety and physical performance. The main practical point is that a burette has to deliver a controlled volume reliably, with markings, connections and materials that remain suitable for the intended medical use.
Design and functional layout
Clause 4 requires the burette to be made from rigid or semi-rigid plastics material and to allow observation of the fluid in the chamber. It also requires filtered air-venting above the top graduation mark, and the burette must be able to receive fluid from the main container or from the injection site or Luer activated valve, then be closed off and used as a separate self-vented reservoir.
If the burette claims light protection, the graduated burette and attached drip chamber have to meet the light-resistance requirements taken from ISO 8536-15. That matters because manufacturers must treat light-protective versions as a distinct design case, not as a simple label claim.
Graduated scale and accuracy
Clause 4 also sets rules for the graduated scale. The burette must have one or more identical scales, with marked units of volume, uniformly formed graduation lines, and numbering at least at the intervals given in Table 1. The scale has to be laid out so that the zero position compensates for the volume displaced by the shut-off device, outlet position or bottom cap.
The scale accuracy is verified by the method in Annex A and has to meet the tolerances in Table 1. Table 1 also links the nominal capacity to the scale interval and the required overall scale length, so users know how to read the burette and verify that the delivered volume stays within the standard’s limits.
If the scale layout is varied for a specific application, the variation has to be assessed for risk in accordance with ISO 14971 and for usability in accordance with IEC 62366-1. In practice, this means any non-standard marking arrangement needs documented safety and user-interface review.
Materials, contamination and biological safety
Clause 5 requires the materials to conform to the physical, chemical and biological requirements in Clauses 6, 7 and 8, and to be assessed in accordance with ISO 10993-1. This connects the burette design to biological safety evaluation, which is important for medical-device material selection and validation.
Clause 6.1 requires the design, manufacturing and transportation of burettes to minimize particulate contamination, with particulate testing of the final infusion set carried out in line with ISO 8536-4 or ISO 8536-10 as an add-on accessory. Clause 7 and Clause 8 require chemical and biological performance to follow ISO 1135-4 or ISO 8536-4, as applicable.
Leakage, air inlet, filter and drip chamber
Clause 6.3 distinguishes between burettes used only for gravity infusion and burettes intended for both gravity and pressure applications. Gravity-only leakage follows ISO 8536-4, while upstream leakage for combined gravity and pressure use follows ISO 8536-8.
Clause 6.4 requires the air-inlet device to meet ISO 8536-4 and ISO 24072. Clause 6.5 requires either a fluid filter or a filter for blood and blood components, depending on the intended application, with the relevant ISO 8536-4 or ISO 1135-4 requirement.
Clause 6.6 requires the drip chamber to allow continuous observation of drops and sets geometric and performance conditions for the drip tube and drip chamber. It also links the drop former to a defined drop output at a stated temperature and flow rate, which matters when the burette is used to control small delivery volumes.
What changed in ISO 8536-5 from the previous edition?
ISO 8536-5:2026 replaces ISO 8536-5:2004 and is described as technically revised. The stated changes are:
- the scope was changed to treat burettes as components of infusion and transfusion devices
- the scope was expanded to include additional applications of burettes in transfusion applications
- clauses on light-resistance, the graduated scale, particulate contamination, air-inlet, leakage and drop former requirements were added or revised
- clauses on labelling, packaging and disposal were removed
- Annexes A, B and C were added
Which standards are used with ISO 8536-5?
ISO 8536-5 relies on several companion standards for testing and risk control. ISO 8536-4 supports gravity-feed infusion set requirements, including particulate testing, leakage, tensile strength and chemical or biological requirements. ISO 1135-4 supports transfusion-set requirements and the filter for blood and blood components.
ISO 8536-8 provides the leakage requirements for pressure applications, and ISO 8536-10 is used for add-on accessory cases and particulate testing. ISO 8536-15 provides the light-protective drip chamber requirements. ISO 10993-1 supports biological evaluation, ISO 14971 supports risk management, IEC 62366-1 supports usability engineering, and ISO 24072 supports the air-inlet filter test.
What does the ISO 8536-5 document contain?
The document contains a detailed description of burette construction, scale layout and component naming, including an example figure of a burette and its parts. It also includes the scale requirements and the table that ties nominal capacity to scale interval, scale length and tolerance.
Annex A gives a step-by-step test method for checking burette scale graduation accuracy with sodium chloride solution and weighing. Annex B explains the rationale behind the current requirements and the history of the revision. Annex C gives sustainability considerations for design, testing, packaging and device life cycle. Annex D explains the difference between attributive and variable testing, which helps manufacturers choose test strategies that provide the right level of evidence for design verification and quality control.
Relations
- Effective Date
- 12-Feb-2026
- Consolidates
ISO 8404:2021 - Tools for moulding — Angle pins - Effective Date
- 16-Dec-2023
- Effective Date
- 02-Dec-2023
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ISO/FDIS 8536-5 - Infusion equipment for medical use — Part 5: Burette infusion sets for single use, gravity feed
REDLINE ISO/FDIS 8536-5 - Infusion equipment for medical use — Part 5: Burette infusion sets for single use, gravity feed
ISO/FDIS 8536-5 - Matériel de perfusion à usage médical — Partie 5: Appareils non réutilisables de perfusion à burette, à alimentation par gravité
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Frequently Asked Questions
ISO 8536-5 is a draft published by the International Organization for Standardization (ISO). Its full title is "Infusion equipment for medical use — Part 5: Burette infusion sets for single use, gravity feed". This standard covers: 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.
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.
ISO 8536-5 is classified under the following ICS (International Classification for Standards) categories: 11.040.20 - Transfusion, infusion and injection equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 8536-5 has the following relationships with other standards: It is inter standard links to FprEN ISO 8536-5, ISO 8404:2021, ISO 8536-5:2004. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 8536-5 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
FINAL DRAFT
International
Standard
ISO/FDIS 8536-5
ISO/TC 76
Infusion equipment for medical
Secretariat: DIN
use —
Voting begins on:
2026-09-03
Part 5:
Burette infusion sets for single use,
Voting terminates on:
2026-10-29
gravity feed
Matériel de perfusion à usage médical —
Partie 5: Appareils non réutilisables de perfusion à burette, à
alimentation par gravité
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 SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 8536-5:2026(en) © ISO 2026
FINAL DRAFT
ISO/FDIS 8536-5:2026(en)
International
Standard
ISO/FDIS 8536-5
ISO/TC 76
Infusion equipment for medical
Secretariat: DIN
use —
Voting begins on:
Part 5:
Burette infusion sets for single use,
Voting terminates on:
gravity feed
Matériel de perfusion à usage médical —
Partie 5: Appareils non réutilisables de perfusion à burette, à
alimentation par gravité
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 SUPPOR TING DOCUMENTATION.
© ISO 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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 Reference number
ISO/FDIS 8536-5:2026(en) © ISO 2026
ii
ISO/FDIS 8536-5:2026(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 .4
4.4 Overall length of scale to nominal capacity line .4
4.5 Variation of scale .4
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 .5
6.6 Drip chamber and drip tube .5
7 Chemical requirements . 5
8 Biological requirements . 6
Annex A (normative) Test method for burette scale graduation accuracy . 7
Annex B (informative) Rationale, guidance and history of the development of this document . 8
Annex C (informative) Sustainability .11
Annex D (informative) Attributive and variable testing .13
Bibliography . 14
iii
ISO/FDIS 8536-5:2026(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;
— addition or revision 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, 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
FINAL DRAFT International Standard ISO/FDIS 8536-5:2026(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.
NOTE 1 Annex 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 C provides recommendations regarding sustainability.
NOTE 3 Annex 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.
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: Requirements and general 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/
ISO/FDIS 8536-5:2026(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
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 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/
Luer activated valve (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 and attached drip chamber which is denoted as items 3 and 6 in Figure 1.
4.1.6 The nominal volume of the burette shall be designated by the total graduated capacity.
ISO/FDIS 8536-5:2026(en)
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 Graduation lines shall be of uniform thickness. They shall lie in planes at right angles to the axis of
the burette.
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 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 in accordance with IEC 62366-1.
Examples of scales and the numbering of graduation lines are shown in Figure 2.
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 The accuracy of the scale shall be tested in accordance with Annex A and shall meet the accuracy
requirements of Table 1.
Table 1 — Volume and scale intervals for burettes
Tolerance on any graduated capacity
Minimum Increment
Less than half
Nominal overall length between
and more Equal to or
Less than
capacity of of scale to Scale interval graduation
than or equal greater than
20 % nominal
burette nominal lines to be
to 20 % half nominal
capacity
capacity mark numbered
nominal capacity
capacity
V
ml mm ml ml
±(1,5 % of V +1 % of expelled ±5 % of ex-
V < 50 67 2,0 10
volume) pelled volume
±(1,5 % of V +1 % of expelled ±5 % of ex-
V ≥ 50 75 5,0 10
volume) pelled 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.
...
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
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ISO/FDIS 8536-5:2026(en)
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
ISO/FDIS 8536-5:2026(en)
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
ISO/FDIS 8536-5:2026(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;
— — 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
ISO/FDIS 8536-5:2026(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.
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
ISO/FDIS 8536-5:2026(en)
— — 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.
ISO/FDIS 8536-5:2026(en)
Key
ISO/FDIS 8536-5:2026(en)
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.
ISO/FDIS 8536-5:2026(en)
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.
ISO/FDIS 8536-5:2026(en)
ISO/FDIS 8536-5:2026(en)
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
...
PROJET FINAL
Norme
internationale
ISO/FDIS 8536-5
ISO/TC 76
Matériel de perfusion à usage
Secrétariat: DIN
médical —
Début de vote:
2026-09-03
Partie 5:
Appareils non réutilisables de
Vote clos le:
2026-10-29
perfusion à burette, à alimentation
par gravité
Infusion equipment for medical use —
Part 5: Burette infusion sets for single use, gravity feed
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
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FOURNIR UNE DOCUMENTATION EXPLICATIVE.
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Numéro de référence
ISO/FDIS 8536-5:2026(fr) © ISO 2026
PROJET FINAL
ISO/FDIS 8536-5:2026(fr)
Norme
internationale
ISO/FDIS 8536-5
ISO/TC 76
Matériel de perfusion à usage
Secrétariat: DIN
médical —
Début de vote:
Partie 5: 2026-09-03
Appareils non réutilisables de
Vote clos le:
2026-10-29
perfusion à burette, à alimentation
par gravité
Infusion equipment for medical use —
Part 5: Burette infusion sets for single use, gravity feed
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
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Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
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ISO/FDIS 8536-5:2026(fr) © ISO 2026
ii
ISO/FDIS 8536-5:2026(fr)
Sommaire Page
Avant-propos .iv
1 Domaine d'application . 1
2 Références normatives . 1
3 Termes et définitions . 2
4 Exigences générales . . 2
4.1 Conception .2
4.2 Échelle graduée .3
4.3 Numérotation des échelles.5
4.4 Longueur totale de l'échelle par rapport à la ligne de capacité nominale .5
4.5 Variation de l'échelle .5
5 Matériaux . 5
6 Exigences physiques . 5
6.1 Contamination particulaire .5
6.2 Résistance à la traction .5
6.3 Étanchéité .5
6.4 Dispositif de prise d'air .5
6.5 Filtre à fluide/filtre pour le sang et ses composants .6
6.6 Chambre compte-gouttes et tube compte-gouttes .6
7 Exigences chimiques . 6
8 Exigences biologiques. 6
Annexe A (normative) Essai d'exactitude de graduation d'échelle pour une burette . 7
Annexe B (informative) Justification, recommandations et historique de l'élaboration
du présent document . . 8
Annexe C (informative) Développement durable .11
Annexe D (informative) Essais attributifs et variables .13
Bibliographie . 14
iii
ISO/FDIS 8536-5:2026(fr)
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes nationaux
de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est en général
confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude a le droit de faire
partie du comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l'ISO participent également aux travaux. L'ISO collabore étroitement avec
la Commission électrotechnique internationale (IEC) en ce qui concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d'approbation requis pour les différents types de documents ISO. Le présent document
a été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2
(voir www.iso.org/directives).
L'ISO attire l'attention sur le fait que la mise en application du présent document peut entraîner l'utilisation
d'un ou de plusieurs brevets. L'ISO ne prend pas position quant à la preuve, à la validité et à l'applicabilité
de tout droit de propriété revendiqué à cet égard. À la date de publication du présent document, l'ISO
n'avait pas reçu notification qu'un ou plusieurs brevets pouvaient être nécessaires à sa mise en application.
Toutefois, il y a lieu d'avertir les responsables de la mise en application du présent document que des
informations plus récentes sont susceptibles de figurer dans la base de données de brevets, disponible à
l'adresse www.iso.org/brevets. L'ISO ne saurait être tenue pour responsable de ne pas avoir identifié tout ou
partie de tels droits de brevet.
Les appellations commerciales éventuellement mentionnées dans le présent document sont données pour
information, par souci de commodité, à l'intention des utilisateurs et ne sauraient constituer un engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion de
l'ISO aux principes de l'Organisation mondiale du commerce (OMC) concernant les obstacles techniques au
commerce (OTC), voir www.iso.org/avant-propos.
Le présent document a été élaboré par le comité technique ISO/TC 76, Appareils de transfusion, de perfusion
et d'injection et appareils destinés au traitement du sang à usage médical et pharmaceutique.
Cette troisième édition annule et remplace la deuxième édition (ISO 8536-5:2004), qui a fait l'objet d'une
révision technique.
Les principales modifications sont les suivantes:
— une modification du domaine d'application afin de prendre en considération les burettes comme
composants d'appareils de perfusion;
— une extension du domaine d'application pour inclure des applications supplémentaires de burettes dans
les applications de transfusion;
— ajout ou révision de paragraphes concernant les exigences relatives à la résistance à la lumière, à l'échelle
graduée, à la contamination particulaire, à la prise d'air, à l'étanchéité, et au dispositif de formation de
gouttes;
— suppression des paragraphes concernant l'étiquetage, l'emballage, et l'élimination;
— ajout des Annexes A, B et C.
Une liste de toutes les parties de la série ISO 8536 se trouve sur le site web de l'ISO.
Il convient que l'utilisateur adresse tout retour d'information ou toute question concernant le présent
document à l'organisme national de normalisation de son pays. Une liste exhaustive desdits organismes se
trouve à l'adresse www.iso.org/fr/members.html.
iv
PROJET FINAL Norme internationale ISO/FDIS 8536-5:2026(fr)
Matériel de perfusion à usage médical —
Partie 5:
Appareils non réutilisables de perfusion à burette, à
alimentation par gravité
1 Domaine d'application
Le présent document spécifie les exigences relatives aux burettes non réutilisables à utiliser comme sous-
composants dans les appareils de perfusion et transfuseurs stérilisés non réutilisables dans des conditions
d'alimentation par gravité ou avec un appareil de perfusion sous pression.
NOTE 1 L’Annexe B fournit des explications sur l'historique de l'élaboration de la norme et résume les différents
arguments abordés dans l'ISO/TC 76 pendant la collaboration du présent document.
NOTE 2 L’Annexe C fournit des recommandations relatives à la durabilité.
NOTE 3 L’Annexe D fournit des informations sur les essais attributifs et variables.
2 Références normatives
Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur
contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique. Pour
les références non datées, la dernière édition du document de référence s'applique (y compris les éventuels
amendements).
ISO 1135-4, Matériel de transfusion à usage médical — Partie 4: Transfuseurs non réutilisables, à alimentation
par gravité
ISO 8536-4, Matériel de perfusion à usage médical — Partie 4: Appareils de perfusion non réutilisables, à
alimentation par gravité
ISO 8536-8, Matériel de perfusion à usage médical — Partie 8: Appareils de perfusion non réutilisables avec des
appareils de perfusion sous pression
ISO 8536-10, Matériel de perfusion à usage médical — Partie 10: Accessoires pour tubulures non réutilisables
avec un matériel de perfusion sous pression
ISO 8536-15, Matériel de perfusion à usage médical — Partie 15: Perfuseurs photoprotecteurs à usage unique
ISO 10993-1, Évaluation biologique des dispositifs médicaux — Partie 1: Exigences et principes généraux pour
l’évaluation de la sécurité biologique au sein d’un processus de gestion des risques
ISO 14971, Dispositifs médicaux — Application de la gestion des risques aux dispositifs médicaux
ISO 24072, Méthode d’essai de rétention bactérienne dans les aérosols pour les filtres d'admission d’air utilisés
sur les dispositifs d’administration
IEC 62366-1, Dispositifs médicaux — Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux
dispositifs médicaux
ISO/FDIS 8536-5:2026(fr)
3 Termes et définitions
Aucun terme n'est défini dans le présent document.
L'ISO et l'IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en normalisation,
consultables aux adresses suivantes:
— ISO Online browsing platform: disponible à l'adresse https:// www .iso .org/ obp
— IEC Electropedia: disponible à l'adresse https:// www .electropedia .org/
4 Exigences générales
4.1 Conception
4.1.1 Une conception type ainsi que la nomenclature à utiliser pour les burettes sont données à la
Figure 1.
Légende
a
1 site d'injection
2 prise d'air avec filtre à air et obturateur
3 burette graduée
4 système d'arrêt
5 tube compte-gouttes
6 chambre compte-gouttes
7 filtre à fluide/filtre pour le sang et ses composants
a
Facultatif.
b
Voir l'ISO 8536-4 pour les exigences relatives aux filtres à fluide.
c
Voir l'ISO 1135-4 pour les exigences relatives aux filtres pour le sang.
Figure 1 — Exemple d'une burette
4.1.2 La burette doit être un tube en matière plastique rigide ou semi-rigide et doit permettre l'observation
du fluide dans la chambre.
ISO/FDIS 8536-5:2026(fr)
4.1.3 La burette doit être pourvue d'un dispositif de filtrage et d'aération placé au-dessus de la graduation
supérieure.
4.1.4 La burette doit pouvoir recevoir un fluide provenant du réservoir principal (ou du site d'injection/
de la vanne actionnée par luer (LAV) le cas échéant) et être obturée pour servir de réservoir indépendant
autoventilé.
4.1.5 Pour les burettes qui demandent une protection contre la lumière, les exigences relatives aux
chambres compte-gouttes spécifiées dans l'ISO 8536-15 doivent s'appliquer à la burette graduée et à la
chambre compte-gouttes attachée qui sont indiquées en tant qu'élément 3 et 6 sur la Figure 1.
4.1.6 Le volume nominal de la burette doit être désigné par la capacité totale graduée.
4.2 Échelle graduée
4.2.1 La burette ne doit comporter qu'une seule échelle ou plusieurs échelles identiques, qui doivent être
graduées et numérotées au moins aux intervalles donnés dans le Tableau 1. L'unité de volume doit être
marquée sur la burette.
NOTE L'intervalle de graduation peut être inférieur (plus fin) à l'intervalle de graduation donné dans le Tableau 1.
4.2.2 Les lignes de graduation doivent être d'épaisseur uniforme. Elles doivent se trouver dans des plans à
angle droit par rapport à l'axe de la burette.
4.2.3 Les lignes de graduation doivent être régulièrement espacées le long de l'axe longitudinal entre la
ligne de graduation zéro et la ligne pour la capacité totale graduée.
4.2.4 Lorsque la burette est maintenue verticalement, les extrémités de toutes les lignes de graduation de
longueur similaire doivent être situées verticalement l'une au-dessous de l'autre.
Il est recommandé que les longueurs des lignes de graduation courtes sur chaque échelle fassent
approximativement la moitié de la longueur des lignes longues. Si différentes configurations de lignes de
graduation sont utilisées, cela doit être soumis à une évaluation d'utilisabilité selon l'IEC 62366-1.
Des exemples d'échelles et la numérotation des lignes de graduation sont présentés à la Figure 2.
4.2.5 Le repère du zéro sur la burette doit être situé dans une position qui prévoit une compensation pour
le volume déplacé par tout système d'arrêt, par la position de l'orifice de sortie par rapport à la base de la
burette, et par tout autre élément du protecteur susceptible d'avoir une incidence sur la lecture.
4.2.6 L'exactitude de l'échelle doit être soumise à l'essai conformément à l’Annexe A et doit satisfaire aux
exigences d'exactitude du Tableau 1.
ISO/FDIS 8536-5:2026(fr)
Tableau 1 — Volume et intervalles de graduation des burettes
Tolérance sur toute capacité graduée
Longueur to-
Inférieure à
Incrément
tale minimale
la moitié et Égale ou
Capacité entre les
Inférieure
de l'échelle Intervalle de
supérieure supérieure à
nominale de lignes de
à 20 % de
par rapport au graduation
ou égale la moitié de
la burette graduation à
la capacité
repère de capa-
à 20 % la capacité
numéroter
nominale
cité nominale
de la capacité nominale
nominale
V
ml mm ml ml
±(1,5 % de V + 1 % du volume ±5 % du vo-
V < 50 67 2,0 10
expulsé) lume expulsé
±(1,5 % de V + 1 % du volume ±5 % du vo-
V ≥ 50 75 5,0 10
expulsé) lume expulsé
Le volume expulsé désigne tout le liquide éjecté au point où le ménisque du niveau d'eau coïncide avec le repère du zéro de
l'échelle.
Volume nominal 50 ml 100 ml 150 ml
NOTE Les lignes verticales sont facultatives.
Figure 2 — Échelles graduées types pour utilisation sur les burettes
ISO/FDIS 8536-5:2026(fr)
4.3 Numérotation des échelles
4.3.1 Les lignes de graduation doivent être numérotées au moins au niveau du volume des incréments
donnés dans le Tableau 1.
Des exemples de numérotation d'échelle sont présentés à la Figure 2.
4.3.2 Lorsque la burette est maintenue verticalement avec l'é
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