ISO/FDIS 7886-1

• Abstract:

  ISO 7886-1:2017 specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans. Sterile syringes specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time. It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist). Hypodermic syringes without a needle specified in this document are intended for use with hypodermic needles specified in ISO 7864.

• Status: Not Published
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: ISO/TC 84 - Devices for administration of medicinal products and catheters
• Drafting Committee: ISO/TC 84 - Devices for administration of medicinal products and catheters
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 16-Oct-2026
• Completion Date: 16-Oct-2026

• Consolidates: FprEN ISO 7886-1 - Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO/FDIS 7886-1:2026)
• Effective Date: 12-Feb-2026
• Consolidates: ISO 4917-4:2024 - Design of nuclear power plants against seismic events — Part 4: Components
• Effective Date: 17-Aug-2024
• Revises: ISO 7886-1:2017 - Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
• Effective Date: 06-Jun-2022

ISO/FDIS 7886-1 is an ISO document for sterile hypodermic syringes for single use, Part 1: syringes for manual use. It specifies design requirements and test methods for empty syringes, with or without needle, intended for end-user filling and use mainly in humans. The document is aimed at verifying syringe design, packaging, and marking, not at lot release.

What does ISO/FDIS 7886-1 specify?

ISO/FDIS 7886-1 specifies the requirements and test methods for empty sterile single-use hypodermic syringes made of plastic or other materials, for withdrawal and injection after filling by the end-user. It also sets packaging and manufacturer-information rules that help keep the syringe sterile and usable at the point of care.

The scope excludes insulin syringes, single-use glass syringes, syringes for power-driven syringe pumps, manufacturer pre-filled syringes, and syringes meant to be stored after filling. Hypodermic syringes without a needle are intended to be used with hypodermic needles specified in ISO 7864.

Clauses 1 to 7 cover scope, normative references, terms and definitions, nomenclature, requirements, packaging, and information supplied by the manufacturer. Annexes A to I provide the supporting test methods and sample-preparation steps.

Annex	What it covers
A	Preparation of extracts for chemical checks
B	Air leakage past the plunger stopper during withdrawal, and separation of plunger stopper and plunger
C	Force needed to operate the piston
D	Dead space determination
E	Liquid leakage at the plunger stopper under compression
F	Silicone quantity test method
G	Sample preparation for particulate determination
H	Expelled volume determination
I	Scale fastness determination

What are the key requirements of ISO/FDIS 7886-1?

ISO/FDIS 7886-1 is a performance-oriented standard. It focuses on safety, dose accuracy, cleanability, sterility maintenance, and readable markings, while leaving room for manufacturers to choose materials and design details.

Design and materials

Clause 5.1 treats the general requirements as design inputs. Syringes must be free from defects that could affect appearance, safety, or performance, and any integrated or add-on sharps protection must comply with ISO 23908.

Barrel flanges must be large, strong, and shaped for secure handling. Their design is to be supported by risk analysis and usability engineering in accordance with IEC 62366-1, which matters in practice because poor finger grips can affect control during injection.

Clause 5.2 leaves material choice open, but requires materials suitable for the intended use and readable markings on the barrel. In practice, the manufacturer has to select materials and print quality that support safe use rather than relying on a prescribed material list.

Cleanliness, biocompatibility, and lubricants

Clause 5.3 addresses cleanliness and chemical/biological suitability. The syringe surfaces that contact the fluid must be free from extraneous matter, extractables are checked for acidity/alkalinity and metals, pyrogenicity is addressed through recognized endotoxin approaches, and biocompatibility is evaluated in accordance with ISO 10993-1.

Clause 5.3 also sets particulate-contamination expectations and links sample preparation to Annex G. For manufacturers, this means particulate control is part of process validation and change control, not just final inspection.

Clause 5.4 limits lubricants on the interior surface and in the polymer formulation. Annex F gives a method for measuring silicone quantity. This matters because excess lubricant can affect readability, contribute to visible particles, or interfere with clean fluid delivery.

Functional performance

Clauses 5.6 and 5.7 cover the piston, plunger stopper, and nozzle. The plunger stopper must remain attached during the withdrawal test in Annex B, the plunger must be long enough to traverse the barrel, and the syringe should not roll excessively when placed on a slope.

The nozzle fitting must conform to ISO 80369-7, and the nozzle layout depends on nominal capacity. For smaller syringes, the nozzle position and lumen size are controlled so the syringe remains compatible and practical to use.

Clauses 5.8 to 5.11 bring the key performance checks together. Table 1 links nominal capacity to expelled-volume tolerance, dead space, scale layout, and test forces; Table 2 defines dead-space classes for smaller syringes; Annex D measures dead space; Annex E checks leakage under compression; Annex C covers piston-operating force; Annex H determines expelled volume; and Annex I checks that scale markings remain legible after handling.

Clause 5.11 also requires a validated sterilization process and packaging that preserves sterility through shelf-life and shipping validation. In practice, the manufacturer must show that the sterile barrier system still works after transport and storage.

Packaging and marking

Clause 6 covers unit packaging, multiple unit packs, user packaging, and the newer rigid unit packaging category. The packaging must protect the syringe, maintain sterility, and make any opening obvious.

Clause 7 defines the information supplied by the manufacturer. Marking includes single-use identification, sterility, batch or lot identification, contents, expiry information, and, where applicable, LDS or ULDS identification. For the user, this is what supports correct selection, traceability, and safe point-of-use handling.

What terms does ISO/FDIS 7886-1 define?

• Dead space - The liquid remaining in the syringe after the plunger stopper is fully depressed during normal use.
• Nominal capacity - The capacity designated by the manufacturer, such as the syringe size the product is sold and specified for.
• Total graduated capacity - The capacity shown by the furthest graduation line, which may equal or exceed the nominal capacity.
• Fiducial line - The leading edge on the plunger stopper that aligns with the zero mark when the piston is fully inserted.
• Plunger stopper - The component at the leading end of the plunger that seals the open end of the barrel.
• Self-contained syringe - A syringe fitted with protective end caps that help maintain sterility of the interior.
• Rigid unit packaging - A rigid sleeve with end cap(s) that maintains sterility until the package is opened.

Who uses ISO/FDIS 7886-1?

ISO/FDIS 7886-1 is used by syringe manufacturers, packaging engineers, sterilization teams, and laboratory staff who verify design and performance. Quality managers and regulatory teams use it to define acceptance criteria for cleanliness, dose delivery, marking, and sterile-barrier performance.

It is also relevant to buyers and specifiers of medical devices, especially when they need to distinguish between manual-use syringes, insulin syringes, prefilled products, and syringes intended for later storage after filling. Healthcare product developers use it when designing syringe systems for human use.

What changed in ISO/FDIS 7886-1 from the previous edition?

ISO/FDIS 7886-1 is the third edition and it cancels and replaces ISO 7886-1:2017.

The main changes stated in the document are:

• Requirements are reorganized into a single Clause 5 with clearer subclauses.
• Particulate matter control is tightened and supported by a new Annex G.
• The expelled-volume structure is revised, including a new low-fill tolerance tier and a new Annex H method.
• Smaller syringes now use tiered dead-space classes, with LDS and ULDS identification on packaging where applicable.
• Inspection conditions for marking legibility and extraneous-matter checks are defined.
• Sterility assurance and scale fastness are now formally addressed, with Annex I for scale marking durability.
• Rigid unit packaging is added as a packaging category.
• Normative references are updated, including IEC 62366-1, ISO 3696, and ISO 15223-1.

Which standards are used with ISO/FDIS 7886-1?

Standard	What it contributes
ISO 3696	Water quality for analytical and test procedures
ISO 10993-1	Biological evaluation within a risk-management process
ISO 23908	Requirements for sharps protection mechanisms
IEC 62366-1	Usability engineering for medical devices
ISO 80369-7	Compatibility of the nozzle conical fitting
ISO 7864	Needle compatibility for syringes without a needle
ISO 8537	The excluded insulin-syringe family for comparison
ISO 15223-1	Symbols used for single-use, sterile, expiry, and damage warnings
ISO 14971	Risk management used where the standard calls for risk assessment
ISO/TR 19244	Guidance on transition periods for ISO/TC 84 standards

What does the ISO/FDIS 7886-1 document contain?

ISO/FDIS 7886-1 contains a component nomenclature figure, performance tables, packaging and marking rules, and a set of supporting test annexes. The tables connect syringe capacity with volume tolerance, dead space, scale layout, and test forces, so they are used directly for design verification and product specification.

The annexes provide the practical methods behind the requirements. Some are normative and therefore part of the compliance path, while others are informative and give suggested ways to test force or silicone quantity.

The document is structured so manufacturers can verify cleanliness, leakage, dose delivery, scale durability, and sterility maintenance using defined procedures. It is therefore used in product development, type testing, and manufacturing validation for sterile manual-use hypodermic syringes.

FINAL DRAFT
International
Standard
ISO/TC 84
Sterile hypodermic syringes for
Secretariat: DS
single use —
Voting begins on:
2026-10-16
Part 1:
Syringes for manual use
Voting terminates on:
2026-12-11
Seringues hypodermiques stériles, non réutilisables —
Partie 1: Seringues pour utilisation manuelle
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Reference number
FINAL DRAFT
International
Standard
ISO/TC 84
Sterile hypodermic syringes for
Secretariat: DS
single use —
Voting begins on:
Part 1:
Syringes for manual use
Voting terminates on:
Seringues hypodermiques stériles, non réutilisables —
Partie 1: Seringues pour utilisation manuelle
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ii
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Nomenclature . 3
5 Requirements . 5
5.1 General requirements .5
5.2 Material selection .5
5.3 Extraneous matter .5
5.3.1 General .5
5.3.2 Limits for acidity or alkalinity .5
5.3.3 Limits for extractable metals .6
5.3.4 Pyrogenicity .6
5.3.5 Biocompatibility .6
5.3.6 Limits for particulate matters .6
5.4 Lubricant .6
5.5 Dimensions .7
5.5.1 Barrel .7
5.5.2 Barrel flanges .7
5.6 Plunger stopper/plunger assembly .7
5.7 Nozzle .8
5.7.1 Conical fitting .8
5.7.2 Position of nozzle on end of barrel .8
5.7.3 Nozzle lumen . .8
5.8 Standard test environmental conditions .8
5.9 Tolerance on expelled volume .8
5.10 Graduated scale . .10
5.10.1 Scale .10
5.10.2 Numbering of scales .11
5.10.3 Overall length of scale to nominal capacity line .11
5.10.4 Variation of scale .11
5.10.5 Fastness of scale.11
5.11 Performance . 12
5.11.1 Dead space . 12
5.11.2 Freedom from air and liquid leakage past plunger stopper . 12
5.11.3 Force to operate the piston . 12
5.11.4 Fit of plunger stopper/plunger in barrel . 12
5.11.5 Sterility assurance . 12
5.11.6 Expelled volume . 12
6 Packaging.12
6.1 Unit packaging and self-contained syringe units . 12
6.1.1 Unit packaging . 12
6.1.2 Self-contained syringe units or rigid unit packaging . 13
6.2 Multiple unit pack . 13
6.3 User packaging . 13
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 syringe units or rigid unit packaging .14
7.3 Unit packaging .14

iii
7.4 Multiple unit packs .14
7.4.1 General .14
7.4.2 Multiple unit packs with self-contained syringes . . 15
7.5 User packaging . 15
7.6 Storage container . 15
7.7 Transport wrapping . .16
Annex A (normative) Method for preparation of extracts . 17
Annex B (normative) Test method for air leakage past syringe plunger stopper during
withdrawal, and for separation of plunger stopper and plunger .18
Annex C (informative) Test method for the determination of forces required to operate the
piston .21
Annex D (normative) Method for determination of dead space .24
Annex E (normative) Test method for liquid leakage at syringe plunger stopper under
compression .25
Annex F (informative) Test method for the quantify of silicone .27
Annex G (informative) Sample preparation for particulate determination .30
Annex H (normative) Method for determination of expelled volume .32
Annex I (normative) Method for determination of scale fastness .33
Bibliography .35

iv
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, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 205, Non-active medical devices, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 7886-1:2017), which has been technically
revised.
The main changes are as follows:
― Restructured requirements: all requirements are consolidated into a single Clause 5, with new formal
subclauses added for material selection, pyrogenicity, biocompatibility, particulate matter, sterility
assurance, scale fastness, and expelled volume.
― New particulate matter limits: explicit sub-visible particle limits are established (≤3 000 particles
≥10 µm; ≤300 particles ≥25 µm per syringe), supported by a new Annex G for sample preparation.
― Revised volume tolerance structure: a third tolerance tier is added for volumes less than 20 % of nominal
capacity (±10 % of expelled volume), and the terminology shifts from “graduated capacity” to “expelled
volume”, with a new normative gravimetric test method (Annex H).
― Tiered dead space categories for small syringes: for syringes <5 ml, three dead space tiers are introduced ‒
RDS (≤0,070 ml), LDS (≤0,025 ml), and ULDS (≤0,015 ml) ‒ replacing the single maximum value in the
2017 edition, with required labeling of LDS/ULDS on packaging.
― Defined inspection conditions: specific illuminance and viewing distance requirements are now
specified for both marking legibility (<100 lx, 30 to 70 cm) and extraneous matter inspection (≥500 lx,
30 to 70 cm).
−6
― New sterility assurance and scale fastness requirements: a formal SAL of 10 with shelf-life and shipping
validation is now required, and a new normative Annex I defines a tape adhesion and solvent resistance
test for scale markings.
v
― Rigid unit packaging added: a new packaging category, rigid unit packaging [rigid sleeve with end cap(s)]
is introduced with corresponding labelling requirements throughout Clause 7.
― Updated normative references: IEC 62366-1 (usability engineering) is elevated to normative status,
ISO 3696 is added to specify water purity grade 3 for test reagents, and ISO 15223-1.
A list of all parts in the ISO 7886 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.

vi
Introduction
The ISO 7886 series covers hypodermic syringes primarily intended for human use and provides
performance and testing requirements. It permits broader variation in design so as not to limit innovation
and methods of packaging. Its appearance and layout are consistent with other related standards which are
designed to be more performance-based compared to design-prescriptive.
General requirements as design guidelines for manufacturers are introduced in this document. Several
limits for requirements which are historic based but confirmed in practice for many years have been kept.
Materials to be used for the construction and lubrication of sterile syringes for single use are not specified as
their selection will depend to some extent upon the design, process of manufacture and sterilization method
employed by individual manufacturers. The materials of the syringe should be compatible with injection
fluids. If this is not the case, the attention of the user should be drawn to the exception by labelling on unit
packaging. It is not practicable to specify a universally acceptable test method for incompatibility, as the
only conclusive test is that an individual specific injection fluid is compatible with a specific syringe.
Manufacturers of pharmaceuticals use solvents in injectable preparations. Such solvents should be tested by
the manufacturer of the injectable preparation for any possible incompatibility with the materials frequently
used in syringe construction. If an incompatibility is identified, the injection fluid should be suitably labelled.
The impossibility of testing any one injection fluid with all available syringes is recognized and it is strongly
recommended that regulatory authorities and relevant trade associations recognize the problem and take
appropriate measures to assist manufacturers of injectable preparations.
Syringes should be manufactured and sterilized in accordance with recognized national or international
codes of good manufacturing practice for medical devices.
The sampling plans for inspection selected for the ISO 7886 series 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 requirements that appear in quality management systems, e.g. ISO 9001 or ISO 13485.
Manufacturers are expected to follow a risk-based approach and employ usability engineering during the
design, development and manufacture of syringes.
Guidance on transition periods for implementing the requirements of the ISO 7886 series is given in
ISO/TR 19244.
vii
FINAL DRAFT International Standard ISO/FDIS 7886-1:2026(en)
Sterile hypodermic syringes for single use —
Part 1:
Syringes for manual use
1 Scope
This document specifies requirements and test methods for verifying the design of empty sterile single-
use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the
withdrawal and injection of fluids after filling by the end-users. Sterile syringes specified in this document
are intended for use immediately after filling and are not intended to contain the medicament for extended
periods of time.
This document does not provide requirements for lot release. The syringes are primarily for use in humans.
It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use
with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be
stored after filling (e.g. in a kit for filling by a pharmacist).
Hypodermic syringes without a needle specified in this document are intended for use with hypodermic
needles specified in ISO 7864.
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 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 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
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for
intravascular or hypodermic applications
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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
barrel flanges
flanges that protrude from the barrel (also referred to as finger grips) to provide the user an ergonomic
means of gripping the syringe during injection
3.2
dead space
volume of liquid left in the syringe when the plunger stopper (3.12) is fully depressed during normal use
3.3
fiducial line
leading edge on the plunger stopper (3.12) that is in contact with and perpendicular to the syringe barrel and
aligns with the zero marking on the syringe barrel when the piston (3.10) is fully inserted
3.4
graduated capacity
volume markings printed on the syringe barrel and the maximum amount of liquid the syringe can accurately
measure and hold
3.5
multiple unit pack
multiple syringes packaged with a single seal that maintains the sterility of the product
3.6
needle cap
needle shield
sheath intended to physically protect the needle prior to use
3.7
nominal capacity
capacity of the syringe as designated by the manufacturer
EXAMPLE 1 ml, 5 ml, 50 ml
3.8
nozzle cap
sheath intended to physically protect the nozzle prior to use
3.9
nozzle lumen
internal space or cavity within the syringe nozzle through which the fluid passes, extending from the internal
end of the syringe barrel where the nozzle begins and continuing through to the tip of the nozzle
3.10
piston
assembled component of plunger (3.11) and plunger stopper (3.12)
3.11
plunger
device component which advances the plunger stopper (3.12) to deliver the medicinal product
3.12
plunger stopper
component connected to the leading end of the plunger (3.11) and that seals the open end of the syringe
barrel
3.13
rigid unit packaging
rigid sleeve with end cap(s), which maintains the sterility of the contents until the package is opened

3.14
self-contained syringe
syringe with protective end caps [i.e. plunger cap, and nozzle cap (3.8) or needle cap (3.6)] intended to
maintain the sterility of the interior of the syringe
3.15
total graduated capacity
capacity of the syringe at the graduation line furthest from the zero graduation line
Note 1 to entry: The total graduated capacity may be equal to, or greater than, the nominal capacity.
3.16
unit packaging
packaging which has direct contact with the device and maintains the sterility of the product
3.17
user packaging
packaging designed to contain one or more unit packages or self-contained syringe (3.14) units
Note 1 to entry: Self-contained syringe units can be packed in multiple unit packs (3.5).
4 Nomenclature
The nomenclature for the components of hypodermic syringes for single use is shown in Figure 1.

Key
1 needle cap or needle shield (if used)
2 nozzle cap
3 nozzle lumen
4 nozzle
5 barrel
6 plunger stopper (3-piece only)
7 seals
8 plunger
9 push-button
10 plunger cap
11 barrel flanges (finger grips)
12 fiducial line
13 nominal capacity
14 graduation lines
15 zero line
16 needle tube
17 hub
18 piston
NOTE The figure is intended to be illustrative of the components of a syringe. The plunger stopper/plunger
assembly can be of integral construction and can incorporate more than one seal.
Figure 1 — Schematic representation of hypodermic syringes for single use

5 Requirements
5.1 General requirements
The general requirements are considered to be design inputs for manufacturers.
Syringes shall be free from defects affecting appearance, safety and performance for their intended use.
Syringes with integrated or add-on sharps protection shall also conform with ISO 23908.
The syringe’s barrel flanges shall be of adequate size, shape and strength for the intended purpose. The
design specifications for the barrel flanges shall be determined through risk analysis and confirmed through
the application of usability engineering in accordance with IEC 62366-1.
5.2 Material selection
The materials shall satisfy the requirement for freedom from regarding acceptable levels of pyrogens and
toxins appropriate to the intended use of the product.
Materials used in the construction of the wall of the syringe barrel shall have sufficient clarity to enable the
user to read dosages with normal or corrected to normal vision and environmental lighting conditions of
< 100 lx, and from a reading distance of between 30 cm and 70 cm.
NOTE 1 The legibility of markings inspection is supposed to ensure that users of needle-based injection systems
(NIS) are able to read the markings under real life conditions (e.g. limited light intensity).
NOTE 2 The lighting levels chosen for this subclause were the lowest levels listed in ISO/CIE 8995-1 and depict
ambient lighting levels that are likely to be seen in private homes or in the entrance halls, rest rooms or corridors of
public spaces (e.g. hotels or hospitals). This level is chosen as representative of what patients – users of these syringes
- can be expected to encounter as they look to read markings on these devices. Other lighting levels can be appropriate
based on the intended use of the syringe.
The document does not specify materials to be used for the construction and lubrication of sterile syringes
with or without needles for single use, because their selection will depend, to some extent, upon the
manufacturers specific syringe design, process of manufacture and sterilization method.
5.3 Extraneous matter
5.3.1 General
The surfaces of the syringe that come in contact with injection fluids during normal use shall be free from
particles and extraneous matter when inspected without magnification, with normal or corrected to normal
vision under an illuminance of minimum 500 lx, and from a reading distance of between 30 cm and 70 cm.
NOTE 1 Conformity with this requirement is 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/CIE 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.
The requirement shall be demonstrated by preparing the solutions specified 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.
The pH value of both solutions can 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.
This requirement shall be demonstrated by preparing the solutions specified in Annex A and testing
them using a recognized micro-analytical method, for example, by an atomic absorption method or by an
inductively coupled plasma mass spectrometry method (ICP).
This test shall be performed whenever there is any change in construction material.
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/ST72 as suggested by ISO 10993-11:2017, Annex G.
Other references to this test can be found in USP <85> and/or EU pharmacopeia.
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 shall be evaluated in accordance with ISO 10993-1. Other relevant parts of the ISO 10993
series can be applied when appropriate to the intended clinical use and contact characteristics of the syringe.
5.3.6 Limits for particulate matters
Sterilized syringes shall be manufactured by processes that minimize 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 parenterals) 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
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.
The amount and distribution of lubricant applied should be optimized to minimize lubricant visibility.
NOTE 1 An acceptable lubricant is silicone complying with a national or the European pharmacopoeia and
ISO 10993-1.
For lubricants incorporated in the polymer formulation, the quantity of lubricant shall not exceed 0,6 %
(weight fraction) of the mass of the component, but attention is drawn to the fact that some national
regulations can specify a lower maximum concentration.
NOTE 2 If a lubricant is incorporated in the polymer formulation, visible particles can become apparent when the
lubricant blooms to the surface of the syringe barrel and the plunger stopper scrapes it off.
NOTE 3 Example of acceptable lubricants incorporated in the polymer formulation are fatty acid amides of erucic
and/or oleic acids conforming with ISO 10993-1.
NOTE 4 See Annex F for a test method for the quantity of silicone oil.
5.5 Dimensions
5.5.1 Barrel
Maximum capacity shall be determined by risk assessment with consideration of, for example, removal of
air bubbles or risk of overdose.
5.5.2 Barrel flanges
The open end of the barrel shall be provided with barrel flanges. Barrel flanges shall be of adequate size,
shape and strength for the intended purpose and shall enable the syringe to be held securely during use.
5.6 Plunger stopper/plunger assembly
When tested in accordance with Annex B, the plunger stopper shall not become detached from the plunger.
The plunger shall be of a length adequate to allow the plunger stopper to traverse the full length of the
barrel. By risk assessment, the manufacturer shall set and verify a specification for an increased force for
removal of the piston completely from the barrel.
The projection of the plunger and the configuration of the push-button should be such as to allow the
plunger to be operated without difficulty. When the fiducial line of the plunger stopper coincides with the
zero graduation line, the minimum length of the plunger from the surface of the barrel flanges nearer to the
push-button, as shown in Figure 2, shall be at least 8 mm.
Key
1 minimum 8 mm
Figure 2 — Minimum length between barrel flanges and plunger push-button
The syringe design, such as barrel flanges, shall be such that the syringe will not roll more than 180° when it
is placed on a flat surface at an angle of 10° to the horizontal. The barrel flanges shall be free from flash and
sharp edges.
Finger grip configurations that do not conform to these requirements are recommended to be assessed for
risk according to ISO 14971 and for usability according to IEC 62366-1.

5.7 Nozzle
5.7.1 Conical fitting
The male conical fitting of the syringe nozzle shall be in accordance with ISO 80369-7.
If the syringe has a locking fitting, it shall be in accordance with ISO 80369-7.
5.7.2 Position of nozzle on end of barrel
5.7.2.1 On syringes of nominal capacity of less than 5 ml, the syringe nozzle shall be situated centrally, i.e.
it shall be coaxial with the barrel.
5.7.2.2 On syringes of nominal capacity of 5 ml and greater, the syringe nozzle shall be situated either
centrally or eccentrically.
5.7.2.3 If the syringe nozzle is eccentric, its axis shall be vertically below the axis of the barrel when the
syringe is lying on a flat surface with the scale uppermost. The distance between the axis of the nozzle and
the nearest point on the internal surface of the bore of the barrel shall be not greater than 4,5 mm.
5.7.3 Nozzle lumen
The nozzle lumen shall have a diameter of not less than 1,2 mm.
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 Tolerance on expelled volume
The tolerances on the expelled volume at each graduation shall be as given in Table 1.

Table 1 — Capacity tolerance, dead space, scale dimensions and test forces
Nominal Tolerance on expelled volume at any graduation Maximum Minimum Scale Increment Forces and pressures for
capacity of dead space overall length interval between leakage testing
syringe of scale to graduation (see Annex E)
nominal ca- lines to be
V
Less than 20 % Less than half Equal to or greater Side Axial pressure
pacity mark numbered
nominal and more than than half nominal force (gauge)
capacity or equal to 20 % capacity
(±5 %) (±5 %)
nominal capacity
ml ml mm ml ml N kPa
±10 % of ex- ±(1,5 % of V + 2 % ±5 % of
V < 2 0,07 25 0,05 0,1 0,25 300
pelled volume of expelled volume) expelled volume
±10 % of ex- ±(1,5 % of V + 2 % ±5 % of
2 ≤ V < 5 0,07 27 0,2 1 1,0 300
pelled volume of expelled volume) expelled volume
±10 % of ex- ±(1,5 % of V + 1 % ±4 % of
5 ≤ V < 10 0,075 36 0,5 1 2,0 300
pelled volume of expelled volume) expelled volume
±10 % of ex- ±(1,5 % of V + 1 % ±4 % of
10 ≤ V < 20 0,10 44 1,0 5 2,0 300
pelled volume of expelled volume) expelled volume
±(1,5 % of V + 1 % ±4 % of
20 ≤ V < 30 0,15 52 2,0 10 3,0 200
of expelled volume) expelled volume
±(1,5 % of V + 1 % ±4 % of
30 ≤ V < 50 0,17 67 2,0 10 3,0 200
of expelled volume) expelled volume
±(1,5 % of V + 1 % ±4 % of
V ≥ 50 0,20 75 5,0 10 3,0 200
of expelled volume) expelled volume
NOTE 1  Expelled volume means all the liquid ejected with the seal brought to the physical limit that was designed to be coincident with the zero mark of the scale.
NOTE 2  Only for syringes with nominal capacity of Volume (V) less than 5 ml is expressed as RDS = Regular Dead Space, LDS = Low Dead Space and ULDS = Ultra Low Dead Space
as designated in Table 2.
EXAMPLE 1  For a 3 ml syringe, when filled to the 1 ml graduation (less than 1/2 capacity), the required tolerance would be ±(1,5 % × 3 ml + 2 % × 1 ml) = 0,065 ml
EXAMPLE 2  For a 3 ml syringe, when filled to the 2 ml graduation (greater than 1/2 capacity), the required tolerance would be ±(5 % × 2 ml) = 0,100 ml.
EXAMPLE 3  For a 1 ml syringe, when filled to the 0,1 ml graduation (less than 20 % nominal capacity), the required tolerance would be ±10 % = 0,01 ml

Table 2 — Dead space definition for nominal syringes capacity V < 5
Maximum dead space
ml
Regular dead space Low dead space Ultra low dead space
(RDS) (LDS) (ULDS)
0,070 0,025 0,015
5.10 Graduated scale
5.10.1 Scale
5.10.1.1 The syringe 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
barrel.
NOTE The scale interval can be less (finer) than the scale interval given in Table 1.
5.10.1.2 The total graduated capacity may be equal to, or greater than, the nominal capacity. If the scale
is extended beyond the nominal capacity, the extended portion shall be differentiated from the rest of the
scale.
Examples of means of differentiation are the following:
a) encircling the scale number of the nominal capacity line;
b) using smaller scale numbers for the extra graduation lines;
c) using shorter graduation lines for the extra graduation lines;
d) using a broken line for the optional vertical line of the extra scale length.
5.10.1.3 Graduation lines shall be of uniform thickness. They shall lie in planes at right angles to the axis of
the barrel.
5.10.1.4 Graduation lines shall be evenly spaced along the longitudinal axis between the zero graduation
line and the line for the total graduated capacity.
5.10.1.5 When the syringe 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 can be submitted to usability
evaluation according to IEC
...

Text for ISO/FDIS 7886-1:2026(en)
ISO/TC 84
Date: 2026-06-02
Secretariat: DS
Date: 2026-10-01
Sterile hypodermic syringes for single use — —
Part 1:
Syringes for manual use
Seringues hypodermiques stériles, non réutilisables —
Partie 1: Seringues pour utilisation manuelle
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© FDIS stage
All rights reserved. Unless otherwise specified,
This ISO publication is protected by copyright and is owned by ISO and/or its licensors.
The content of this ISO publication is provided under licence, not sold. Use is subject to the applicable licence terms issued
by ISO, an ISO member body, or an authorized third-party distributor.
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Phone: + 41 22 749 01 11
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Published in Switzerland
iii
Contents
Foreword . vi
Introduction . viii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Nomenclature . 3
5 Requirements . 6
5.1 General requirements . 6
5.2 Material selection . 6
5.3 Extraneous ISO 10993 matter . 6
5.4 Lubricant . 7
5.5 Dimensions . 8
5.6 Plunger stopper/plunger assembly . 8
5.7 Nozzle . 9
5.8 Standard test environmental conditions . 10
5.9 Tolerance on expelled volume . 10
5.10 Graduated scale . 12
5.11 Performance . 14
6 Packaging . 15
6.1 Unit packaging and self-contained syringe units . 15
6.2 Multiple unit pack . 15
6.3 User packaging . 15
7 Information supplied by the manufacturer . 16
7.1 General . 16
7.2 Syringes . 16
7.3 Unit packaging . 16
7.4 Multiple unit packs . 17
7.5 User packaging . 18
7.6 Storage container . 18
7.7 Transport wrapping . 19
Annex A (normative) Method for preparation of extracts . 20
Annex B (normative) Test method for air leakage past syringe plunger stopper during
withdrawal, and for separation of plunger stopper and plunger . 21
Annex C (informative) Test method for the determination of forces required to operate the
piston . 25
Annex D (normative) Method for determination of dead space . 31
Annex E (normative) Test method for liquid leakage at syringe plunger stopper under
compression . 32
Annex F (informative) Test method for the quantify of silicone . 34
Annex G (informative) Sample preparation for particulate determination . 37
Annex H (normative) Method for determination of expelled volume . 39
Annex I (normative) Method for determination of scale fastness . 41
Bibliography . 43
iv
v
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/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'sISO’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 committeeCommittee ISO/TC 84, Devices for administration of
medicinal products and catheters, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 205, Non-active medical devices, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 7886--1:2017), which has been technically
revised.
The main changes to the previous edition are the followingas follows:
— Restructured requirements: Allall requirements are consolidated into a single Clause 5Section 5,, with new
formal subclauses added for material selection, pyrogenicity, biocompatibility, particulate matter, sterility
assurance, scale fastness, and expelled volume.
— New particulate matter limits: Explicitexplicit sub-visible particle limits are established (≤3 ,000 particles
≥10 µm; ≤300 particles ≥25 µm per syringe), supported by a new Annex Gnormative Annex G for sample
preparation.
— Revised volume tolerance structure: Aa third tolerance tier is added for volumes less than 20 % of nominal
capacity (±10 % of expelled volume), and the terminology shifts from "“graduated capacity"” to "“expelled
volume,"”, with a new normative gravimetric test method (Annex H(Annex H).).
— Tiered dead space categories for small syringes: Forfor syringes <5 ml, three dead space tiers are
introduced — ‒ RDS (≤0.,070 ml), LDS (≤0.,025 ml), and ULDS (≤0.,015 ml) —‒ replacing the single
maximum value in the 2017 edition, with required labeling of LDS/ULDS on packaging.
vi
— Defined inspection conditions: Specificspecific illuminance and viewing distance requirements are now
specified for both marking legibility (<100 lx, 30– to 70 cm) and extraneous matter inspection (≥500 lx,
30– to 70 cm).
−6
— New sterility assurance and scale fastness requirements: Aa formal SAL of 10⁻⁶ with shelf-life and
shipping validation is now required, and a new normative Annex IAnnex I defines a tape adhesion and
solvent resistance test for scale markings.
— Rigid unit packaging added: Aa new packaging category, rigid unit packaging ([rigid sleeve with end
cap(s)))] is introduced with corresponding labelinglabelling requirements throughout Clause 7Section 7.
— Updated normative references: IEC 62366-1 (usability engineering) is elevated to normative status,
ISO 3696 is added to specify water purity grade 3 for test reagents, and ISO 15223-1.
A list of all parts in the ISO 7886 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.
vii
Introduction
The ISO 7886 series covers hypodermic syringes primarily intended for human use and provides performance
and testing requirements. It permits broader variation in design so as not to limit innovation and methods of
packaging. Its appearance and layout are consistent with other related standards which are designed to be
more performance-based compared to design-prescriptive.
General requirements as design guidelines for manufacturers are introduced in this document. Several limits
for requirements which are historic based but confirmed in practice for many years have been kept.
Materials to be used for the construction and lubrication of sterile syringes for single use are not specified as
their selection will depend to some extent upon the design, process of manufacture and sterilization method
employed by individual manufacturers. The materials of the syringe should be compatible with injection
fluids. If this is not the case, the attention of the user should be drawn to the exception by labelling on unit
packaging. It is not practicable to specify a universally acceptable test method for incompatibility, as the only
conclusive test is that an individual specific injection fluid is compatible with a specific syringe.
Manufacturers of pharmaceuticals use solvents in injectable preparations. Such solvents should be tested by
the manufacturer of the injectable preparation for any possible incompatibility with the materials frequently
used in syringe construction. If an incompatibility is identified, the injection fluid should be suitably labelled.
The impossibility of testing any one injection fluid with all available syringes is recognized and it is strongly
recommended that regulatory authorities and relevant trade associations should recognize the problem and
take appropriate measures to assist manufacturers of injectable preparations.
Syringes should be manufactured and sterilized in accordance with recognized national or international codes
of good manufacturing practice for medical devices.
The sampling plans for inspection selected for the ISO 7886 series 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 requirements that appear in quality management systems, e.g. ISO 9001 or ISO 13485.
Manufacturers are expected to follow a risk-based approach and employ usability engineering during the
design, development and manufacture of syringes.
Guidance on transition periods for implementing the requirements of the ISO 7886 (all parts)series is given
in ISO/TR 19244.
viii
DRAFT International Standard ISO/DIS 7886-1:2025(en)

Sterile hypodermic syringes for single use —
Part 1:
Syringes for manual use
1 Scope
This document specifies requirements and test methods for verifying the design of empty sterile single-use
hypodermic syringes, with or without needle, made of plastic or other materials and intended for the
withdrawal and injection of fluids after filling by the end-users. Sterile syringes specified in this document are
intended for use immediately after filling and are not intended to contain the medicament for extended
periods of time.
This document does not provide requirements for lot release. The syringes are primarily for use in humans.
It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use
with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored
after filling (e.g. in a kit for filling by a pharmacist).
Hypodermic syringes without a needle specified in this document are intended for use with hypodermic
needles specified in ISO 7864.
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 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 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
IEC 62366--1, Medical devices — Part 1: Application of usability engineering to medical devices
ISO 80369--7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for
intravascular or hypodermic applications
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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 3.1
barrel flanges
flanges that protrude from the barrel (also referred to as finger grips) to provide the user an ergonomic means
of gripping the syringe during injection
3.2 3.2
dead space
volume of liquid left in the syringe when the plunger stopper (3.12(3.12)) is fully depressed during normal
use.
3.3 3.3
fiducial line
leading edge on the plunger stopper (3.12(3.12)) that is in contact with and perpendicular to the syringe barrel
and aligns with the zero marking on the syringe barrel when the piston (3.10(3.10)) is fully inserted
3.4 3.4
graduated capacity
volume markings printed on the syringe barrel and the maximum amount of liquid the syringe can accurately
measure and hold
3.5 3.5
multiple unit pack
multiple syringes packaged with a single seal that maintains the sterility of the product
3.6 3.6
needle cap
needle shield
sheath intended to physically protect the needle prior to use
3.7 3.7
nominal capacity
capacity of the syringe as designated by the manufacturer
EXAMPLE 1 ml, 5 ml, 50 ml
3.8 3.8
nozzle cap
sheath intended to physically protect the nozzle prior to use
3.9 3.9
nozzle lumen
internal space or cavity within the syringe nozzle through which the fluid passes, extending from the internal
end of the syringe barrel where the nozzle begins and continuing through to the tip of the nozzle
3.10 3.10
piston
assembled component of plunger (3.11(3.11)) and plunger stopper (3.12(3.12))
3.11 3.11
plunger
device component which advances the plunger stopper (3.12(3.12)) to deliver the medicinal product
© ISO #### 2026 – All rights reserved
3.12 3.12
plunger stopper
component connected to the leading end of the plunger (3.11(3.11)) and that seals the open end of the syringe
barrel
3.13 3.13
rigid unit packaging
rigid sleeve with end cap(s), which maintains the sterility of the contents until the package is opened
3.14 3.14
self-contained syringe
syringe with protective end caps [i.e. plunger cap, and nozzle cap (3.8(3.8)) or needle cap (3.6(3.6)])] intended
to maintain the sterility of the interior of the syringe
3.15 3.15
total graduated capacity
capacity of the syringe at the graduation line furthest from the zero graduation line
Note 1 to entry: The total graduated capacity may be equal to, or greater than, the nominal capacity.
3.16 3.16
unit packaging
packaging which has direct contact with the device and maintains the sterility of the product
3.17 3.17
user packaging
packaging designed to contain one or more unit packages or self-contained syringe (3.14(3.14)) units
Note 1 to entry: Self-contained syringe units can be packed in multiple unit packs (3.5(3.5).).
4 Nomenclature
The nomenclature for the components of hypodermic syringes for single use is shown in Figure 1Figure 1.
© ISO #### 2026 – All rights reserved
Key
1 needle cap or needle shield (if used)
2 nozzle cap
3 nozzle lumen
4 nozzle
5 barrel
6 plunger stopper (3-piece only)
7 seals
8 plunger
9 push-button
10 plunger cap
11 barrel flanges (finger grips)
12 fiducial line
13 nominal capacity
14 graduation lines
15 zero line
16 needle tube
17 hub
18 piston
NOTE The figure is intended to be illustrative of the components of a syringe. The plunger stopper/plunger assembly
can or cannot be of integral construction and can or cannot incorporate more than one seal.
Figure 1 — Schematic representation of hypodermic syringes for single use
5 Requirements
5.1 General requirements
The general requirements are considered to be design inputs for manufacturers.
Syringes shall be free from defects affecting appearance, safety and performance for their intended use.
Syringes with integrated or add-on sharps protection shall also complyconform with ISO 23908.
The syringe’s barrel flanges shall be of adequate size, shape and strength for the intended purpose. The design
specifications for the barrel flanges shall be determined through risk analysis and confirmed through the
application of usability engineering according toin accordance with IEC 62366-1.
5.2 Material selection
The materials shall satisfy the requirement for freedom from regarding acceptable levels of pyrogens and
toxins appropriate to the intended use of the product.
Materials used in the construction of the wall of the syringe barrel shall have sufficient clarity to enable the
user to read dosages with normal or corrected to normal vision and environmental lighting conditions of
< 100 lx, and from a reading distance of between 30 cm and 70 cm.
NOTE 1 The legibility of markings inspection is supposed to ensure that users of needle-based injection systems (NIS)
are able to read the markings under real life conditions (e.g. limited light intensity).
NOTE 2 The lighting levels chosen for this subclause were the lowest levels listed in ISO/CIE 8995-1 and depict
ambient lighting levels that are likely to be seen in private homes or in the entrance halls, rest rooms or corridors of
public spaces (e.g. hotels or hospitals). This level is chosen as representative of what patients – users of these syringes -
can be expected to encounter as they look to read markings on these devices. Other lighting levels can be appropriate
based on the intended use of the syringe.
The document does not specify materials to be used for the construction and lubrication of sterile syringes
with or without needles for single use, because their selection will depend, to some extent, upon the
manufacturers specific syringe design, process of manufacture and sterilization method.
5.3 Extraneous 10993 matter
5.3.1 General
The surfaces of the syringe that come in contact with injection fluids during normal use shall be free from
particles and extraneous matter when inspected without magnification, with normal or corrected to normal
vision under an illuminance of minimum 500 lx, and from a reading distance of between 30 cm and 70 cm.
NOTE 1 ComplianceConformity with this requirement will beis 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/CIE 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.
The requirement shall be demonstrated by preparing the solutions specified in Annex AAnnex 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.
© ISO #### 2026 – All rights reserved
The pH value of both solutions can 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.
Conformity with thisThis requirement shall be demonstrated by preparing the solutions specified in
Annex AAnnex A and testing them using a recognized micro-analytical method, for example, by an atomic
absorption method or by an inductively coupled plasma mass spectrometry method (ICP).
This test is toshall be performed whenever there is any change in construction material.
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/ST72 as suggested by ISO 10993-11:2017, Annex G.
Other references to this test can be found in USP <85> and/or EU pharmacopeia.
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 shall be evaluated in accordance with ISO 10993-1. Other relevant parts of the ISO 10993
series can be applied when appropriate to the intended clinical use and contact characteristics of the syringe.
5.3.6 5.3.6 Limits for particulate matters
Sterilized syringes shall be manufactured by processes that minimize 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 parenterals) 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 GAnnex G.
5.4 Lubricant
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.
The amount and distribution of lubricant applied should be optimized to minimize lubricant visibility.
NOTE 1 An acceptable lubricant is silicone complying with a national or the European pharmacopoeia and ISO 10993--
1.
For lubricants incorporated in the polymer formulation, the quantity of lubricant shall not exceed 0,6 %
(w/wweight fraction) of the mass of the component, but attention is drawn to the fact that some national
regulations can specify a lower maximum concentration.
NOTE 2 If a lubricant is incorporated in the polymer formulation, visible particles can become apparent when the
lubricant blooms to the surface of the syringe barrel and the plunger stopper scrapes it off.
NOTE 3 Example of acceptable lubricants incorporated in the polymer formulation are fatty acid amides of erucic
and/or oleic acids conforming with ISO 10993--1.
NOTE 4 See Annex FAnnex F for a test method for the quantity of silicone oil.
5.5 Dimensions
5.5.1 Barrel
Maximum capacity shall be determined by risk assessment with consideration of, for example, removal of air
bubbles or risk of overdose.
5.5.2 Barrel flanges
The open end of the barrel shall be provided with barrel flanges. Barrel flanges shall be of adequate size, shape
and strength for the intended purpose and shall enable the syringe to be held securely during use.
5.6 Plunger stopper/plunger assembly
When tested in accordance with Annex BAnnex B,, the plunger stopper shall not become detached from the
plunger.
The plunger shall be of a length adequate to allow the plunger stopper to traverse the full length of the barrel.
By risk assessment, the manufacturer shall set and verify a specification for an increased force for removal of
the piston completely from the barrel.
The projection of the plunger and the configuration of the push-button should be such as to allow the plunger
to be operated without difficulty. When the fiducial line of the plunger stopper coincides with the zero
graduation line, the minimum length of the plunger from the surface of the barrel flanges nearer to the push-
button, as shown in Figure 2Figure 3,, shall be at least 8 mm.
© ISO #### 2026 – All rights reserved
Key
1 minimum 8 mm
Figure 2 — Minimum length between barrel flanges and plunger push-button
The syringe design, such as barrel flanges, shall be such that the syringe will not roll more than 180° when it
is placed on a flat surface at an angle of 10° to the horizontal. The barrel flanges shall be free from flash and
sharp edges.
Finger grip configurations that do not conform to these requirements are recommended to be assessed for
risk according to ISO 14971 and for usability according to IEC 62366-1.
5.7 Nozzle
5.7.1 Conical fitting
The male conical fitting of the syringe nozzle shall be in accordance with ISO 80369--7.
If the syringe has a locking fitting, it shall be in accordance with ISO 80369-7.
5.7.2 Position of nozzle on end of barrel
5.7.2.1 5.7.2.1 On syringes of nominal capacity of less than 5 ml, the syringe nozzle shall be
situated centrally, i.e. it shall be coaxial with the barrel.
5.7.2.2 5.7.2.2 On syringes of nominal capacity of 5 ml and greater, the syringe nozzle shall be
situated either centrally or eccentrically.
5.7.2.3 5.7.2.3 If the syringe nozzle is eccentric, its axis shall be vertically below the axis of the
barrel when the syringe is lying on a flat surface with the scale uppermost. The distance between the axis of
the nozzle and the nearest point on the internal surface of the bore of the barrel shall be not greater than
4,5 mm.
5.7.3 Nozzle lumen
The nozzle lumen shall have a diameter of not less than 1,2 mm.
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 Tolerance on expelled volume
The tolerances on the expelled volume at each graduation shall be as given in Table 1Table 1.

© ISO #### 2026 – All rights reserved
Table 1 — Capacity tolerance, dead space, scale dimensions and test forces
Nominal Tolerance on expelled volume at any graduation Maximum Minimum Scale Increment Forces and pressures for
capacity of dead space overall length interval between leakage testing
syringe of scale to graduation
(see Annex EAnnex E))
ml ml
nominal lines to be
V
Less than 20 % Less than half and Equal to or greater Side Axial pressure
capacity mark numbered
ml
nominal more than or equal than half nominal force (gauge)
mm ml
capacity to 20 % nominal capacity
(±5 %) (±5 %)
capacity
N kPa
ml  ml mm ml ml N kPa
±10 % of ±(1,5 % of V + 2 % ±5 % of
V < 2 0,07 25 0,05 0,1 0,25 300
expelled volume of expelled volume) expelled volume
±10 % of ±(1,5 % of V + 2 % ±5 % of
2 ≤ V < 5 0,07 27 0,2 1 1,0 300
expelled volume of expelled volume) expelled volume
±10 % of ±(1,5 % of V + 1 % ±4 % of
5 ≤ V < 10 0,075 36 0,5 1 2,0 300
expelled volume of expelled volume) expelled volume
±10 % of ±(1,5 % of V + 1 % ±4 % of
10 ≤ V < 20 0,10 44 1,0 5 2,0 300
expelled volume of expelled volume) expelled volume
±(1,5 % of V + 1 % ±4 % of
20 ≤ V < 30 0,15 52 2,0 10 3,0 200
of expelled volume) expelled volume
±(1,5 % of V + 1 % ±4 % of
30 ≤ V < 50 0,17 67 2,0 10 3,0 200
of expelled volume) expelled volume
±(1,5 % of V + 1 % ±4 % of
V ≥ 50 0,20 75 5,0 10 3,0 200
of expelled volume) expelled volume
NOTE 1  Expelled volume means all the liquid ejected with the seal brought to the physical limit that was designed to be coincident with the zero mark of the scale.
NOTE 2  Only for syringes with nominal capacity of Volume (V) less than 5 ml is expressed as RDS= = Regular Dead Space, LDS= = Low Dead Space and ULDS= = Ultra Low Dead Space as designated in
Table 2Table 2.
EXAMPLE 1  For a 3 ml syringe, when filled to the 1 ml graduation (less than 1/2 capacity), the required tolerance would be ±(1,5 % × 3 ml + 2 % × 1 ml) = 0,065 ml
EXAMPLE 2  For a 3 ml syringe, when filled to the 2 ml graduation (greater than 1/2 capacity), the required tolerance would be ±(5 % × 2 ml) = 0,100 ml.
EXAMPLE 3  For a 1 ml syringe, when filled to the 0,1 ml graduation (less than 20 % nominal capacity), the required tolerance would be ±10 % = 0,01 ml
Table 2 — Dead space definition for nominal syringes capacity V< < 5
Maximum dead space
(ml)
Regular Dead Spacedead space Low Dead Spacedead space Ultra Low Dead Spacelow
dead space
(RDS) (LDS)
(ULDS)
0,070 0,025 0,015
5.10 Graduated scale
5.10.1 Scale
5.10.1.1 5.10.1.1 The syringe 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 barrel.
NOTE The scale interval can be less (finer) than the scale interval given in Table 1Table 1.
5.10.1.2 5.10.1.2 The total graduated capacity may be equal to, or greater than, the nominal
capacity. If the scale is extended beyond the nominal capacity, the extended portion shall be differentiated
from the rest of the scale.
Examples of means of differentiation are the following:
a) a) encircling the scale number of the nominal capacity line;
b) b) using smaller scale numbers for the extra graduation lines;
c) c) using shorter graduation lines for the extra graduation lines;
d) d) using a broken line for the optional vertical line of the extra scale length.
5.10.1.3 5.10.1.3 Graduation lines shall be of uniform thickness. They shall lie in planes at right
angles to the axis of the barrel.
5.10.1.4 5.10.1.4 Graduation lines shall be evenly spaced along the longitudinal axis between the
zero graduation line and the line for the total graduated capacity.
5.10.1.5 5.10.1.5 When the syringe 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 can be submitted to usability
evaluation according to IEC 62366-1.
Examples of scales and the numbering of graduation lines are shown in Figure 3Figure 3.
© ISO #### 2026 – All rights reserved
NOTE 1 The vertical line of the scale can be omitted.
NOTE 2 The figure is not to scale.
Figure 3 — Examples of scale graduations
5.10.2 Numbering of scales
5.10.2.1 5.10.2.1 Graduation lines shall be numbered at least at the volume increments given in
Table 1Table 1. In addition, the line denoting the nominal capacity or the lines denoting the nominal capacity
and the total graduated capacity, if these differ, shall be numbered.
Examples of scale numbering are shown in Figure 3Figure 3.
5.10.2.2 5.10.2.2 When the syringe is held vertically with the conical tip uppermost and 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.
5.10.3 Overall length of scale to nominal capacity line
The overall length of the scale shall be as given in Table 1Table 1.
5.10.4 Variation of scale
If necessary by a specific application, the scale may vary and this requirement does not preclude the provision
of additional graduation marks within the scale or as extensions to the scale. Any variation of the scale or
graduation is recommended to be assessed for risk according to ISO 14971 and for usability according to
IEC 62366-1.
5.10.5 Fastness of scale
When tested in accordance with Annex IAnnex I,, markings shall be legible, and numbers, lines and wording
shall still be visible and understandable.
5.11 Performance
5.11.1 Dead space
Dead space shall be minimized to reduce waste and transmission of infectious agents.
When tested in accordance with Annex DAnnex D,, the maximum volume of liquid contained in the barrel and
the nozzle when the plunger stopper is fully inserted shall be as given in Table 1Table 1.
5.11.2 Freedom from air and liquid leakage past plunger stopper
When tested in accordance with Annex EAnnex E,, there shall be no leakage of water past the plunger stopper
or seal(s). Small droplets between the seals are not considered failure.
The plunger stopper seal shall be designed to ensure no leakage of air past the seal. The manometer reading
shall not fall by more than 1 kPa, ensuring the design minimizes pressure loss while maintaining the required
functionality.
5.11.3 Force to operate the piston
It is recommended to measure the force to operate the piston. A suggested test method and performance
criteria for the forces requirement to move the plunger stopper is given in Annex CAnnex C.
5.11.4 Fit of plunger stopper/plunger in barrel
When the syringe is filled with water to the nominal capacity and held vertically with first one end and then
the other end uppermost, the piston shall not move by reason of its own mass and the water contained.
5.11.5 Sterility assurance
The syringe in its unit packaging shall have been subjected to a validated sterilization process resulting in a
−6
Sterility Assurance Levelsterility assurance level (SAL) of 10 . The packaging shall ensure the content sterility
until end of shelf life through shelf-life studies including a shipping validation.
5.11.6 Expelled volume
Expelled volume shall be determined in accordance with Annex HAnnex H.
© ISO #### 2026 – All rights reserved
6 Packaging
6.1 Unit packaging and self-contained syringe units
6.1.1 Unit packaging
The syringe, together with the needle if supplied, shall be sealed individually in a unit packaging.
The needle may be packaged in its own packaging inside the unit packaging.
The materials and design of the unit packaging should have no detrimental effects on the contents and shall
ensure the following:
a) a) maintenance of sterility of the contents under dry, clean and adequately ventilated storage
conditions;
b) b) minimum risk of contamination of the contents during opening and removal from the
packaging;
c) c) adequate protection of the contents during normal handling, transit and storage;
d) d) that once opened, the packaging cannot be easily resealed, and it shall be obvious that the
packaging has been opened.
6.1.2 Self-contained syringe units or rigid unit packaging
The syringe shall be fitted with needle cap/nozzle cap, and plunger cap.
The materials and design of the syringe unit shall ensure the following:
a) a) maintenance of sterility of the interior of the syringe unit (e.g. the outside surface of the needle,
the protruding part of the plunger and its push-button and the fluid path of the syringe, and needle, if
fitted) under dry, clean and adequately ventilated conditions;
b) b) minimum risk of contamination of the contents during opening of the unit;
c) c) adequate protection of the contents during normal handling, transit and storage.
The syringe or the syringe unit can be provided with a means of indicating that the unit might have been
opened previously.
6.2 Multiple unit pack
The materials and design of the multiple unit pack shall ensure the following:
a) a) minimum risk of contamination of the syringe unit during opening of the pack;
b) b) adequate protection of the syringe units during normal handling, transit and storage;
c) c) that once opened, it shall be obvious that the multiple pack has been opened.
6.3 User packaging
A number of unit packaging, syringe units, or a number of multiple unit packs shall be packed in a user
packaging.
The packaging system shall provide physical protection and integrity of the sterile barrier system during
normal handling, transit, and storage over the shelf life, i.e. until the expiration date.
The design and validation of the packaging shall take into consideration the final use of the syringe and the
storage and shipping conditions and the defined shelf life.
7 Information supplied by the manufacturer
7.1 General
The syringe shall be accompanied by the information that is sufficient for its safe use, taking account of the
training and knowledge of potential users. The information shall include the identity of the manufacturer.
7.2 Syringes
7.2.1 General
The barrels of syringes shall be marked with the following information:
a) a) appropriate graduated scale in accordance with 5.9Clauses 8 and 5.109;;
b) b) total graduated capaci
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