oSIST prEN ISO 8537:2026

SLOVENSKI STANDARD
01-februar-2026
Sterilne injekcijske brizge za insulin za enkratno uporabo, z iglo ali brez nje
(ISO/DIS 8537:2025)
Sterile single-use syringes, with or without needle, for insulin (ISO/DIS 8537:2025)
Sterile Insulin-Einmalspritzen mit oder ohne Kanüle (ISO/DIS 8537:2025)
Seringues à insuline, stériles, non réutilisables, avec ou sans aiguille (ISO/DIS
8537:2025)
Ta slovenski standard je istoveten z: prEN ISO 8537
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 8537
ISO/TC 84
Sterile single-use syringes, with or
Secretariat: DS
without needle, for insulin
Voting begins on:
Seringues à insuline, stériles, non réutilisables, avec ou sans
2025-12-01
aiguille
Voting terminates on:
ICS: 11.040.25 2026-02-23
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
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USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
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POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
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NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 8537:2025(en)
DRAFT
ISO/DIS 8537:2025(en)
International
Standard
ISO/DIS 8537
ISO/TC 84
Sterile single-use syringes, with or
Secretariat: DS
without needle, for insulin
Voting begins on:
Seringues à insuline, stériles, non réutilisables, avec ou sans
aiguille
Voting terminates on:
ICS: 11.040.25
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
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Published in Switzerland Reference number
ISO/DIS 8537:2025(en)
ii
ISO/DIS 8537:2025(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Nomenclature . 4
5 Requirements . 6
5.1 General requirements .6
5.2 Material selection .7
5.3 Extraneous matter .7
5.3.1 General .7
5.3.2 Limits for acidity or alkalinity .7
5.3.3 Limits for extractable metals .7
5.3.4 Pyrogenicity .7
5.3.5 Biocompatibility .8
5.3.6 Limits for particulate matters .8
5.4 Lubricant .8
5.4.1 Lubrication of syringes .8
5.4.2 Lubrication of needle tube .8
5.5 Dimensions .8
5.5.1 Barrel and plunger stopper .8
5.5.2 Finger grips .8
5.6 Plunger/plunger stopper .9
5.6.1 General .9
5.6.2 Fit of plunger stopper in barrel .9
5.7 Nozzle .9
5.7.1 Conical fitting .9
5.7.2 Position of nozzle on end of barrel .9
5.8 Standard test environmental conditions .9
5.9 Colour coding .9
5.10 Needle tubing and needles .10
5.10.1 Needles for syringe types 3 and 4 .10
5.10.2 Needle tubing for syringe types 5, 6, 7 and 8 .10
5.10.3 Bond between hub and needle tube .10
5.11 Performance of assembled syringe .11
5.11.1 Dead space .11
5.11.2 Freedom from leakage at needle .11
5.11.3 Leakage past plunger stopper .11
6 Packaging.11
6.1 Unit packaging and self-contained syringe units .11
6.1.1 General .11
6.1.2 Unit packaging providing sterile barrier syringes (types 1, 3, 5 and 7) . 12
6.1.3 Self-contained syringes with sterile interiors (types 2, 4, 6 and 8) . 12
6.2 Multiple-unit packaging (for syringe types 2, 4, 6 and 8) . 12
6.3 User packaging . 12
7 Information supplied by the manufacturer .13
7.1 General . 13
7.2 Syringes . 13
7.2.1 General . 13
7.2.2 Additional marking for self-contained syringes (syringe types 2, 4, 6 and 8) . 13
7.3 Unit packaging (for syringe types 1, 3, 5 and 7) . 13
7.4 Multiple unit packs (syringe types 2, 4, 6 and 8) .14

iii
ISO/DIS 8537:2025(en)
7.5 User packaging .14
7.6 Storage container . 15
7.7 Transport wrapping . .16
Annex A (normative) Fluid for determination of acidity/alkalinity and extractable metals . 17
Annex B (normative) Test method for air leakage past syringe piston during aspiration and for
separation of rubber stopper and plunger .18
Annex C (normative) Test method for determination of forces required to operate the piston .21
Annex D (normative) Test method for determination of dead space .24
Annex E (normative) Test method for liquid leakage at syringe piston and syringe nozzle/hub
or needle/barrel unions during compression .25
Annex F (normative) Test method for air leakage past nozzle/hub or needle/barrel unions
during aspiration .27
Annex G (normative) Syringe sizes and graduated scales.28
Annex H (informative) Needle bonding strength test method .30
Bibliography .32

iv
ISO/DIS 8537:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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 84, Devices for administration of medicinal
products and catheters.
This forth edition cancels and replaces the third edition (ISO 8537:2016), which has been technically revised.
The main changes are as follows:
— xxx xxxxxxx xxx xxxx
Drafting note: New list to be developed by WG 11.
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.

v
ISO/DIS 8537:2025(en)
Introduction
This document covers insulin syringes primarily intended for human use and provides performance and
testing requirements. It permits broader variation in design so as to not limit innovation in technology or
methods of packaging. Its appearance and layout are consistent with other ISO/TC 84 documents, which are
designed to be more performance-based than design-prescriptive.
Manufacturers are expected to follow a risk-based approach and employ usability engineering during the
design, development and manufacture of insulin syringes.
This edition introduces general requirements as design guidelines for manufacturers. This edition retains a
number of limits on requirements, which were originally based on consensus opinion but subsequently have
been confirmed in practice.
This document does not specify materials to be used for the construction and lubrication of sterile
insulin syringes and needles for single use because their selection will depend, to some extent, upon the
manufacturer’s specific syringe design, process of manufacture, and sterilization method.
Insulin syringes and needles will be manufactured and sterilized in accordance with recognized national or
international codes of good manufacturing practice for medical devices.
This document emphasises the importance of having individual syringes that are appropriately graduated
and labelled for only one concentration of insulin. Serious problems can result if a syringe is used with a
concentration of insulin that is different from the one for which it was designed. Hazards associated with dosing
errors with highly concentrated insulin (U200, U300 and U500) are more severe than with U40 and U100.
It is preferred that when more than one insulin concentration is in a market, the new concentration be
provided in a dedicated delivery system that make mis-dosing less likely.
In acknowledgement that insulin in higher concentrations in vials are available in some markets, new
formulations are under development and dedicated delivery systems other than syringes are not always
appropriate for all markets, this document introduces new colour codes to differentiate syringes for the new
higher concentrations of insulin.
The sampling plans for inspection selected for this document are intended to verify the design at a high
confidence level. The sampling plans for inspection do not replace the more general manufacturing quality
systems that appear in quality management systems, e.g. ISO 9001 or ISO 13485.
Guidance on transition periods for implementing the requirements of this document is given in ISO/TR 19244.

vi
DRAFT International Standard ISO/DIS 8537:2025(en)
Sterile single-use syringes, with or without needle, for insulin
1 Scope
This document specifies requirements and test methods for empty, sterile, single-use syringes, with or
without needles, made of plastic materials and intended solely for the injection of insulin, with which the
syringes are filled by the end user. This document covers syringes intended for single-use only in humans
and with insulins of various concentrations.
The insulin syringes specified in this document are intended for use (i.e. insulin injection) immediately after
filling and are not intended to contain insulin for extended periods of time.
This document excludes single-use syringes made of glass, syringes for use with power-driven syringe
pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g.
in a kit intended for filling by a pharmacist).
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 3696, Water for analytical laboratory use — Specification and test methods
ISO 7864, Sterile hypodermic needles for single use
ISO 9626, Stainless steel needle tubing for the manufacture of medical devices
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11608-1, Needle-based injection systems for medical use — Requirements and test methods — Part 1:
Needle-based injection systems
ISO 11608-5, Needle-based injection systems for medical use — Requirements and test methods — Part 5:
Automated functions
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223-1:2021, Medical devices — Symbols to be used with information to be supplied by the manufacturer
— Part 1: General requirements
ISO 23908, Sharps injury protection — Sharps protection mechanisms for single-use needles, introducers for
catheters and needles used for blood testing, monitoring, sampling and medical substance administration —
Requirements and test methods
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for
intravascular or hypodermic applications
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO/DIS 8537:2025(en)
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/
3.1
dead space
volume of liquid left in the syringe and needle, where supplied with the syringe, when the plunger is fully
depressed during normal use
3.2
fiducial line
leading edge of the plunger stopper (3.11), which is in contact with and perpendicular to the syringe barrel
and aligns with the zero marking on the syringe barrel when the piston is fully inserted
3.3
graduated capacity
scale interval or intervals in graduation line
3.4
multiple-unit packaging
package containing more than one self-contained syringe
3.5
needle cap
cover intended to protect physically the needle tube prior to use
3.6
needle length
usable length of needle
Note 1 to entry: Needle length is shown in Figure 1.
3.7
nozzle cap
sheath intended to protect physically the needle hub prior to use
3.8
piston
assembled component of plunger and plungerstopper (3.11)
3.9
plunger cap
cover intended to maintain the sterility of the syringe and to enclose the projecting portion of the plunger
and push button, if present
3.10
plunger delivery
device mechanism which advances the plungerstopper (3.11) to deliver the medicinal product

ISO/DIS 8537:2025(en)
Key
1 needle length
Figure 1 — Needle length
3.11
plunger stopper
component connected to the leading end of the plunger and seals the open end of the syringe barrel
3.12
self-contained syringe
syringe with protective end caps intended to maintain the sterility of the interior of the syringe until one of
the caps is removed
Note 1 to entry: Protective end caps may be plunger cap (3.9), nozzle cap (3.7) or needle cap (3.5).
3.13
total graduated capacity
capacity of the syringe at the graduation line farthest from the zero graduation line
Note 1 to entry: The total graduated capacity may be equal to, or greater than, the nominal capacity.
3.14
unit packaging
package containing a single syringe, with or without a needle, which maintains the sterility of the contents
until the package is opened
3.15
user packaging
packaging which contains one or more items of unit packaging or self-contained syringes or multiple-unit
packaging, but is not intended to maintain sterility of the contents

ISO/DIS 8537:2025(en)
4 Nomenclature
The type of syringe shall be designated as follows (see also Figure 2):
— Type 1; syringe having a 6 % (Luer) male conical fitting, supplied with no needle and packaged in unit
packaging.
— Type 2; syringe having a 6 % (Luer) male conical fitting, supplied with no needle and fitted with
protective plunger and nozzle caps and packaged.
— Type 3; syringe having a 6 % (Luer) male conical fitting and supplied with a detached or detachable
needle and packaged in a unit packaging.
— Type 4; syringe having a 6 % (Luer) male conical fitting and supplied with a detachable needle and fitted
with protective plunger and needle caps and packaged.
— Type 5; syringe having a fitting other than a 6 % (Luer) taper, supplied with a needle not intended to be
detached and packaged in a unit packaging.
— Type 6; syringe having a fitting other than a 6 % (Luer) taper, supplied with a needle not intended to be
detached and fitted with protective caps and packaged.
— Type 7; syringe with fixed needle tube and packaged in a unit packaging.
— Type 8; syringe with fixed needle tube and fitted with protective end caps and packaged.

ISO/DIS 8537:2025(en)
Key
1 needle cap
2 nozzle cap
3 nozzle lumen
4 nozzle
5 barrel
6 plunger stopper
7 seals
8 plunger
9 push-button
10 plunger cap
11 finger grips
12 fiducial line
13 nominal capacity
14 graduation lines
15 zero line
16 needle tube
17 hub
ISO/DIS 8537:2025(en)
NOTE This figure is only intended to be illustrative of the components of a syringe. The piston might or might not
be of integral construction and might incorporate more than one seal.
Figure 2 — Schematic representation of insulin syringe for single use
NOTE This document provides designations for eight types of syringes to encompass different product
configurations, but the number of types in use in a particular country is likely to be fewer than eight.
5 Requirements
5.1 General requirements
The general requirements listed below are considered to be design guidelines for manufacturers.
a) Given the likelihood that multiple insulin concentrations and concentration-specific syringes will exist
in a particular country or locality, the manufacturer shall develop risk mitigation strategies to minimize
the occurrence of “wrong dose” medication errors.
b) The syringe shall indicate, through visual means, the insulin concentration it is intended to contain.
The insulin syringes should also indicate, through non-visual means (e.g. tactile), the insulin
concentration it is intended to contain.
c) Syringes designed to contain a specific concentration of insulin (e.g. U-100) shall be adequately
differentiated visually from other dedicated syringes. This differentiation shall be determined based on
a risk assessment and confirmed through usability validation testing.
d) The syringe and needle should be free from defects affecting safety, serviceability for their intended
use, and appearance.
e) The syringe scale shall be graduated in increments corresponding to units of only one concentration
of insulin. The syringe scale graduation and numbering increments shall be determined through risk
analysis and confirmed through usability validation testing.
NOTE Annex H offers guidance from prior versions of ISO 8537 for graduation and numbering increments on
U-40 and U-100 syringes.
f) The nominal capacity of the syringe shall be designated in millilitres (ml).
g) The tolerances on the graduated capacity shall be in accordance with Table H.1.
h) Syringes indicated for use with devices or accessories that provide automated functions (e.g. needle
insertion and retraction) shall comply with applicable requirements of ISO 11608-1 and ISO 11608-5.
i) Syringes with integrated or add-on sharps protection shall comply with ISO 23908.
j) Syringes with Luer attachment features shall comply with ISO 80369-7.
k) The length of the barrel shall be sufficient to allow the expulsion of any air bubbles without affecting the
syringe’s nominal capacity.
NOTE Compliance with this requirement may be demonstrated, for example, by meeting the requirements in 5.6.1.
l) The syringe’s finger grips shall be of adequate size, shape and strength for the intended purpose. The
design specifications for the finger grips shall be determined through risk analysis and confirmed
through usability validation testing.
m) The materials used in the syringe shall be tested and qualified according to ISO 10993-1.
n) The self-contained syringes with sterile interiors and syringes provided in its unit packaging shall have
−6
been subjected to a validated sterilization process resulting in a Sterility Assurance Level (SAL) of 10 .

ISO/DIS 8537:2025(en)
The packaging shall ensure the content sterility until end of shelf life through shelf life studies including
a shipping validation.
o) The materials shall satisfy the appropriate national requirements or regulations for freedom from
regarding acceptable levels of pyrogens and toxins appropriate to the intended use of the product
NOTE Testing for these properties is described in Annex G.
5.2 Material selection
With regard to material selection,
— materials used for fabrication of the syringe barrel shall be of sufficient clarity to enable dosages to be
read and for air bubbles to be seen without difficulty, and
— materials used for fabrication of syringes and needles (including lubricant) and packaging shall not, in
their final form after sterilization and under conditions of intended use, adversely affect the efficacy,
safety and acceptability of insulin preparations. The fabrication materials shall also not be affected,
either physically or chemically, by insulin preparations.
5.3 Extraneous matter
5.3.1 General
The surfaces of the syringe and needle that come in contact with insulin shall be clean and free from
extraneous matter when inspected without magnification, with normal or corrected to normal vision under
an illuminance of min. 500 lx, and from a reading distance of between 30 cm and 70 cm.
NOTE 1 Compliance with this requirement will be determined through inspection by an individual with normal
vision (or corrected-to-normal vision), without magnification.
NOTE 2 The lighting levels chosen for this subclause were the lighting levels listed in ISO 8995-1 expected to be
seen in inspection areas in the chemical, plastics or rubber industry.
5.3.2 Limits for acidity or alkalinity
Exposure of distilled water to the finished syringe product shall not change its pH value by more than one unit.
Compliance with this requirement may be demonstrated by preparing the solutions described in Annex A.
The results shall show that the pH value of the syringe assessment fluid is within one pH unit of the pH value
of the control fluid.
NOTE The pH value of both solutions may be determined with a laboratory potentiometric pH meter using a
general purpose electrode.
5.3.3 Limits for extractable metals
Exposure of distilled water to the finished syringe product shall not change its content of metals by more
than a combined total of 5 mg/kg of lead, tin, zinc and iron; the cadmium content shall be less than 0,1 mg/kg.
Compliance with this requirement may be demonstrated by preparing the solutions described in Annex A
and testing them using a recognized micro-analytical method, for example, by an atomic absorption method.
5.3.4 Pyrogenicity
Pyrogenicity mediated by endotoxin can be measured by an endotoxin-specific LAL (Limulus Amebocyte
Lysate) test, referring to the specific test given in AAMI/ST72as suggested by ISO 10993-11:2017, Annex G.
Other references to this test can be found in USP <85> and/or EU pharmacopeia.

ISO/DIS 8537:2025(en)
Extraction method and testing are specified in regional and national pharmacopoeias:
— for extraction method, see USP <161>;
— for testing, see Ph.Eur., 2.6.14, method c), USP <85> and JP 4.01
5.3.5 Biocompatibility
Biocompatibility evaluation of syringes shall be in compliance with ISO 10993 series.
5.3.6 Limits for particulate matters
Sterilized syringes shall be manufactured by processes that reduce the risk of particulate contamination of
the intended content.
The particle-related specifications given in pharmacopoeias (e.g. Ph.Eur., USP, JP) do not apply to empty
containers but to show a certain cleanliness level, specifications have been set.
For sub-visible particles, the following applies:
— particles ≥10 µm: 3 000 max. per syringe.
— particles ≥25 µm: 300 max. per syringe.
NOTE These limits have been derived from the USP <788> (small volume parenteral) limit values for filled
containers with a nominal volume of less than 100 ml. The limits, which is 50 % of the USP <788>, have been chosen
based on historical proven capability using the light obscuration method as given in Annex G.
5.4 Lubricant
5.4.1 Lubrication of syringes
For lubricants applied to interior surface of the syringe, the quantity of lubricant applied shall not exceed
0,25 mg/cm of the interior surface area of the syringe in contact with the injection fluid. If the interior
surfaces of the syringe, including the plunger stopper, are lubricated, the lubricant shall not form pools of
fluid on the interior surface of the syringe.
5.4.2 Lubrication of needle tube
If the needle tube is lubricated, the lubricant shall not be visible to an individual with normal or corrected-
to-normal vision under an illuminance of min. 500 lx, as droplets of fluid on the outside surfaces of the
needle tube.
5.5 Dimensions
5.5.1 Barrel and plunger stopper
The barrel length shall be such that the syringe has a usable capacity of either 10 % more than the nominal
capacity or 3 mm of plunger travel beyond the scale marking, whichever is less.
5.5.2 Finger grips
The open end of the barrel shall be provided with finger grips that prevent the syringe from rolling when the
axis of the barrel is placed perpendicular to the incline of a flat surface angled at 10° from horizontal.

ISO/DIS 8537:2025(en)
5.6 Plunger/plunger stopper
5.6.1 General
The design of the plunger and push-button on the end of the plunger shall be such that when the barrel is
held in one hand, the plunger can be depressed by the thumb of that hand. The plunger stopper shall not
become detached from the plunger during the test described in Annex B.
The projection of the plunger and the configuration of the push-button should be such as to enable the
plunger, when in the fully inserted position, to be grasped and drawn back without difficulty.
5.6.2 Fit of plunger stopper in barrel
When the syringe is filled with water and then held in both vertical orientations (i.e. with the needle end
either up or down), the plunger shall not move by the force of gravity acting on the combined mass of
the plunger and the water in the barrel. When a needle is secured to the syringe in accordance with the
instructions provided by the manufacturer, the force required to initiate movement of the plunger to expel
water from the syringe shall not exceed 15 N.
NOTE Compliance with this requirement can be demonstrated using the procedures described in Annex C.
The fit of the plunger stopper in the barrel should be such that the plunger stopper slides smoothly
throughout the full range of its travel within the barrel.
5.7 Nozzle
5.7.1 Conical fitting
The male conical fitting of the syringe nozzle on syringe types 1, 2, 3 and 4 shall comply with the
requirements of ISO 80369-7.
5.7.2 Position of nozzle on end of barrel
The syringe nozzle shall be situated centrally, i.e. shall be co-axial with the barrel.
5.8 Standard test environmental conditions
Unless otherwise specified, measurements shall be performed under the following atmospheric conditions:
— temperature between 18 °C and 28 °C;
— relative humidity between 25 % RH and 75 % RH.
Testing shall be performed after samples have been stored under these conditions for at least 4 h.
5.9 Colour coding
Colour coding of syringes intended for dedicated use with specific insulin concentrations is as follows.
— The barrel of the insulin syringe shall be clear, with graduation markings of a colour that contrasts
clearly with the syringe.
— The colour used to indicate the insulin concentration shall appear on at least one component of the syringe
(e.g. needle cap, plunger cap, plunger, a portion of the barrel that does not interfere with visibility of the
graduation lines).
— For insulin syringes with fixed needles, the colour of the needle cap shall be the colour designated for the
insulin concentration.
ISO/DIS 8537:2025(en)
— The colour coding used on the syringes shall be repeated and explained on the user packaging and, if
applicable, on the unit packaging.
NOTE 1 The presence of colour coding on a syringe or package does not absolve the user of the responsibility
to check the marked insulin concentration of the syringe.
— No additional colours, other than black and white, shall be used on the syringe barrel.
NOTE 2 In acknowledgement that established syringes on the market use red to indicate the U40 insulin
strength on the barrel, these syringes are exempted.
— The dedicated colours used to indicate insulin concentration shall be the following:
— red for U40;
— orange for U100.
The following colours are given in order to prevent regional variation and to prevent the use of the same
colour for different concentrations and different colours for the same concentration:
— light blue U200;
— yellow for U300;
— purple for U400;
— green for U500.
For the newly introduced colours and for any new colour selected, the complete information provided for the
user shall be assessed for risk according to ISO 14971 and for usability according to IEC 62366-1.
NOTE 3 These colour restrictions do not apply to detachable needles.
5.10 Needle tubing and needles
5.10.1 Needles for syringe types 3 and 4
Needles for syringe types 3 and 4 shall be in accordance with ISO 7864.
5.10.2 Needle tubing for syringe types 5, 6, 7 and 8
Needle tubing for syringe types 5, 6, 7 and 8 shall be in accordance with ISO 9626.
The needle point shall be in accordance with ISO 7864.
The needle length shall be measured as shown in Figure 1 and the tolerance of the needle length shall be
within ±1,25 mm.
5.10.3 Bond between hub and needle tube
The bond between the hub and needle tube shall withstand at least the strength forces shown in Table 1. See
also Annex I.
Table 1 — Minimum strength of bond between hub and needle tube for different needle sizes
Nominal outside
diameter of needle Minimum shearing strength
(mm)
≥0,33 22 N (5 lbs)
<0,33 11 N (2,5 lbs)
ISO/DIS 8537:2025(en)
5.11 Performance of assembled syringe
5.11.1 Dead space
Dead space is described as RDS=Regular Dead Space, LDS=Low Dead Space and ULDS=Ultra Low Dead Space
as designated in Table 2.
Table 2 — Maximum dead space
Maximum dead space
(ml)
Type of
Regular Dead Low Dead Ultra Low
Syringe
Space
Space Dead Space
(RDS)
(LDS) (ULDS)
1 and 2 0,070 0,025 0,015
3 and 4 0,100 0,030 0,020
5 and 6 NA NA 0,020
7 and 8 NA NA 0,010
NOTE Refer to Clause 4 for types of syringes (with or without needle).
5.11.2 Freedom from leakage at needle
There shall be no leakage of water sufficient to form a falling drop within 30 s from the junction point
between the syringe nozzle and the needle hub or the junction point between the syringe and the needle
tube, as appropriate.
NOTE 1 Compliance with this requirement may be demonstrated using the method described in Annex E.
There shall be no continued formation of air bubbles from the junction point between the syringe nozzle and
the needle hub or the junction point between the syringe and the needle tube, as appropriate.
NOTE 2 Compliance with this requirement may be demonstrated using the method described in Annex F.
5.11.3 Leakage past plunger stopper
There shall be no leakage of water past the piston seal.
NOTE 1 Compliance with this requirement may be demonstrated using the method described in Annex E.
There shall be no leakage of air past the plunger stopper seal and there shall be no drop in the manometer
reading.
NOTE 2 Compliance with this requirement may be demonstrated using the method described in Annex B.
The plunger stopper seal shall be designed to ensure no leaka
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