General Information

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
5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
Start Date
03-Sep-2026
Completion Date
03-Sep-2026

Buy Documents

Draft

ISO/FDIS 8536-5 - Infusion equipment for medical use — Part 5: Burette infusion sets for single use, gravity feed

Release Date:20-Aug-2026
English language (14 pages)
sale 15% off
sale 15% off
Draft

REDLINE ISO/FDIS 8536-5 - Infusion equipment for medical use — Part 5: Burette infusion sets for single use, gravity feed

Release Date:20-Aug-2026
English language (14 pages)
sale 15% off
sale 15% off
Draft

ISO/FDIS 8536-5 - Matériel de perfusion à usage médical — Partie 5: Appareils non réutilisables de perfusion à burette, à alimentation par gravité

Release Date:22-Sep-2026
French language (16 pages)
sale 15% off
sale 15% off

Overview

ISO/FDIS 8536-5:2026 sets forth requirements for single-use burette infusion sets used in medical environments, specifically for gravity feed operations. This standard applies to burettes with 50 ml, 100 ml, and 150 ml nominal capacities and focuses on ensuring compatibility with containers for infusion solutions and intravenous equipment. Additionally, the standard outlines material quality, physical, chemical, and biological performance, and considers usability engineering and sustainability factors in design and production.

Complying with ISO/FDIS 8536-5 assures healthcare providers and manufacturers that burette infusion sets meet stringent international requirements for safety, compatibility, and performance.

Key Topics

  • Scope and Product Definition
    • Applies to single-use, gravity feed burette infusion sets for medical use, including those used in transfusion and pressure infusion setups.
    • Focuses on burettes as components within finished infusion or transfusion sets.
  • Design and Construction Requirements
    • Specifies rigid or semi-rigid transparent materials for visibility and safe fluid administration.
    • Burettes must feature graduated scales for accurate measurement, air-inlet devices with filters, and suitable shut-off mechanisms.
    • Option for light-protective designs, referencing ISO 8536-15 for requirements.
  • Measurement and Calibration
    • Detailed graduated scale specifications address accuracy, spacing, and numbering for safe and precise dosing.
    • Tolerance and scale accuracy requirements are tested per Annex A.
  • Physical, Chemical, and Biological Safety
    • Requirements include minimization of particulate contamination, adequate tensile strength, and resistance to leakage.
    • Chemical and biological testing ensures materials are non-toxic and safe for medical use, as guided by ISO 10993-1 and relevant standards.
  • Sustainability and Environmental Considerations
    • Recommendations for material selection, waste reduction, and eco-friendly packaging are included to encourage environmentally responsible manufacturing.

Applications

  • Hospitals and Clinics
    • Used for controlled intravenous administration of fluids and medications, especially when precise dosing is required, such as in pediatric or neonate care.
  • Transfusion Procedures
    • Integrated into transfusion sets to ensure compatibility with blood and blood component administration.
  • Critical Care and Emergency Settings
    • Supports rapid and safe set-up for medication delivery and fluid management during emergencies.
  • Infusion Pumps and Gravity Feed Systems
    • Designed to work with gravity feed systems and can be adapted for pressure infusion applications, as required.
  • Sustainable Manufacturing
    • Offers guidance for manufacturers seeking to optimize designs for recyclability, reduce material usage, and streamline testing procedures.

Related Standards

  • ISO 8536-4: Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
  • ISO 1135-4: Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed
  • ISO 8536-8: Infusion sets for single use with pressure infusion apparatus
  • ISO 8536-10: Accessories for fluid lines for single use with pressure infusion equipment
  • ISO 8536-15: Light-protective infusion sets for single use
  • ISO 10993-1: Biological evaluation of medical devices
  • ISO 14971: Application of risk management to medical devices
  • IEC 62366-1: Usability engineering for medical devices

By following ISO/FDIS 8536-5, manufacturers and healthcare providers promote safety, accuracy, and compatibility for single-use burette infusion sets, supporting improved patient care and compliance with international best practices in infusion equipment for medical use.

Relations

Effective Date
12-Feb-2026
Effective Date
16-Dec-2023
Effective Date
02-Dec-2023

Buy Documents

Draft

ISO/FDIS 8536-5 - Infusion equipment for medical use — Part 5: Burette infusion sets for single use, gravity feed

Release Date:20-Aug-2026
English language (14 pages)
sale 15% off
sale 15% off
Draft

REDLINE ISO/FDIS 8536-5 - Infusion equipment for medical use — Part 5: Burette infusion sets for single use, gravity feed

Release Date:20-Aug-2026
English language (14 pages)
sale 15% off
sale 15% off
Draft

ISO/FDIS 8536-5 - Matériel de perfusion à usage médical — Partie 5: Appareils non réutilisables de perfusion à burette, à alimentation par gravité

Release Date:22-Sep-2026
French language (16 pages)
sale 15% off
sale 15% off

Get Certified

Connect with accredited certification bodies for this standard

BSI Group

BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.

UKAS United Kingdom Verified

TÜV Rheinland

TÜV Rheinland is a leading international provider of technical services.

DAKKS Germany Verified

TÜV SÜD

TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.

DAKKS Germany Verified

Sponsored listings

Frequently Asked Questions

ISO/FDIS 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/FDIS 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/FDIS 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/FDIS 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/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
FINAL DRAFT
International
Standard
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
ii
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
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/

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.

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
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
...


PROJET FINAL
Norme
internationale
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,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
NORMES POUVANT
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
Numéro de référence
PROJET FINAL
Norme
internationale
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
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
© ISO 2026 INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
NORMES POUVANT
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse Numéro de référence
ii
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
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
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.
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.

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

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
...