FprEN ISO 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
• Publication Date: 10-Mar-2027
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Start Date: 31-Aug-2026
• Completion Date: 31-Aug-2026
• Ref Project: oSIST prEN ISO 7886-1:2026 - Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO/DIS 7886-1:2025)

• Consolidated By: ISO/FDIS 7886-1 - Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
• Effective Date: 12-Feb-2026
• Revises: EN ISO 7886-1:2018 - Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2017, Corrected version 2019-08)
• Effective Date: 07-Aug-2024

FprEN ISO 7886-1 is the CEN draft of the ISO standard for sterile hypodermic syringes for single use, Part 1: syringes for manual use. It specifies requirements and test methods for empty sterile single-use hypodermic syringes, with or without needle, that are filled by the end user and used mainly in humans. It is a design-verification document, not a lot-release standard.

What does FprEN ISO 7886-1 specify?

FprEN ISO 7886-1 sets design, performance, packaging and marking requirements for manual-use sterile hypodermic syringes for single use. It focuses on syringes intended for immediate use after filling, and it excludes several other syringe types and uses.

The scope covers plastic or other-material syringes, with or without a needle, and notes that needleless syringes are intended for use with hypodermic needles specified in ISO 7864. It also states that the document does not provide lot-release requirements.

The standard is organized into seven clauses and nine annexes:

Annex	What it covers
A	Method for preparation of extracts
B	Air leakage past the plunger stopper during aspiration, and separation of plunger stopper and plunger
C	Force required to operate the piston
D	Dead space
E	Liquid leakage at the plunger stopper under compression
F	Quantity of silicone
G	Sample preparation for particulate determination
H	Expelled volume
I	Scale fastness

What are the key requirements of FprEN ISO 7886-1?

FprEN ISO 7886-1 combines general design controls, material cleanliness, dimensional checks, performance testing, packaging protection and labeling. In practice, it is the document that tells a manufacturer or buyer what has to be designed, tested, packed and marked before a syringe can be treated as compliant.

General design and usability

Clause 5.1 treats the general requirements as design inputs. Syringes shall be free from defects that affect appearance, safety or performance, and syringe designs with sharps protection shall also meet ISO 23908.

Barrel flanges need adequate size, shape and strength, and their design should be supported by risk analysis and usability engineering. That matters because the flange is the user’s main grip point during injection.

Materials, cleanliness and biological safety

Clause 5.2 requires the barrel wall to be clear enough for dose reading under normal or corrected vision, even in low light conditions. The document does not prescribe the materials, because material choice depends on design, manufacture and sterilization method.

Clause 5.3 addresses extraneous matter, extractables, pyrogenicity, biocompatibility and particulate contamination. Annex A gives the extract-preparation method, and the particulate requirement is intended to keep contamination low enough for safe use.

Lubricant and syringe geometry

Clause 5.4 limits lubricant on the interior surface and points to silicone as an acceptable example when it complies with the relevant pharmacopoeial and biocompatibility expectations. The practical point is to control friction without creating visible contamination.

Clauses 5.5 to 5.7 cover barrel capacity, barrel flanges, the plunger stopper/plunger assembly and the nozzle. The nozzle fitting is tied to ISO 80369-7, and the nozzle position depends on nominal capacity. This is important for compatibility, handling and correct fluid delivery.

Scale, capacity and measurement conditions

Clause 5.8 sets standard test environmental conditions. Clause 5.9 and Clause 5.10 tie graduated capacity, scale layout, numbering and scale extension to the syringe’s nominal capacity and total graduated capacity.

Table 1 is central here because it links syringe size to tolerated graduated capacity, scale length, dead space and leakage-related test forces. For the reader, this means the scale and delivery accuracy are not generic - they depend on syringe capacity.

Clause 5.10.5 and Annex I address scale fastness, so markings must remain legible after tape, water and alcohol challenge. That matters for clinical use because the graduation marks must survive handling and cleaning.

Performance, sterility and delivery

Clause 5.11 covers dead space, air and liquid leakage, force to operate the piston, fit of the plunger stopper/plunger in the barrel, sterility assurance and expelled volume. Annexes B, D, E and H provide the related test methods.

The sterility requirement is tied to a validated sterilization process and packaging that maintains sterility through shelf life. In practice, this means the syringe is not just sterile at release - the sterile barrier has to last through storage and shipping.

Packaging and manufacturer information

Clause 6 requires unit packaging, multiple unit packs and user packaging to protect sterility and make opening evident. Self-contained syringe units and rigid unit packaging need protective caps that preserve the sterility of the syringe interior.

Clause 7 covers the information supplied by the manufacturer. The document requires clear identification on the barrel, unit packaging, multiple unit packs, user packaging, storage containers and transport wrapping, including sterile status, single-use status, batch or lot identification, expiry information and, where applicable, dead-space identification as LDS or ULDS.

What terms does FprEN ISO 7886-1 define?

FprEN ISO 7886-1 defines the terms the rest of the document uses for syringe parts, capacity and packaging. These definitions matter because the tests and markings rely on the same component names throughout the standard.

• Barrel flanges - the protruding finger grips on the barrel that help the user hold the syringe during injection.
• Dead space - the liquid left in the syringe when the plunger stopper is fully depressed in normal use.
• Fiducial line - the leading edge on the plunger stopper that aligns with the zero marking when the piston is fully inserted.
• Nominal capacity - the syringe capacity designated by the manufacturer.
• Nozzle lumen - the internal passage through the syringe nozzle where fluid flows.
• Piston - the assembled plunger and plunger stopper component.
• Self-contained syringe - a syringe with protective end caps intended to maintain sterility of the syringe interior.
• Regular Dead Space (RDS), Low Dead Space (LDS) and Ultra Low Dead Space (ULDS) - the dead-space classes used for syringes below 5 ml.

Who uses FprEN ISO 7886-1?

FprEN ISO 7886-1 is used by syringe manufacturers, packaging engineers, test laboratories, quality managers, regulatory teams and buyers in medical devices and healthcare supply chains. It is also relevant to teams responsible for risk management and usability engineering.

Manufacturers use it to set design inputs, choose materials, define scales and verify performance. Test labs use it for extract, leakage, dead-space, expelled-volume and scale-fastness testing. Buyers and quality teams use it to compare syringe offerings and check that packaging and marking match their intended use.

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

FprEN ISO 7886-1 is the third edition and cancels and replaces ISO 7886-1:2016. The foreword says it has been technically revised.

Which standards are used with FprEN ISO 7886-1?

FprEN ISO 7886-1 is built around a small set of direct references and several companion standards used for safety, packaging, symbols and testing.

Standard	What it contributes
ISO 3696	Water quality for extract preparation and test media
ISO 15223-1:2021	Symbols for sterile status, single use, batch code, use-by date and damage warnings
ISO 23908	Requirements for sharps protection mechanisms
ISO 80369-7	Small-bore connector compatibility for intravascular or hypodermic applications
ISO 7864	Needle standard referenced for syringes supplied without a needle
ISO 10993 series	Biological evaluation and biocompatibility of medical devices
ISO 11607-1 and ISO 11607-2	Materials and validation for sterile barrier packaging systems
ISO 14971	Risk management used for design choices and scale variations
IEC 62366-1	Usability engineering for grip design, scale layout and related user features
ISO 14644-1	Cleanroom classification used in particulate sample preparation

What does the FprEN ISO 7886-1 document contain?

FprEN ISO 7886-1 contains a requirements clause and a set of test annexes that support design verification, packaging validation and labeling control. The annexes are practical methods, not theory, so they tell the user how to prepare extracts, measure leakage, check dead space, assess expelled volume and verify marking durability.

It also includes a nomenclature figure for syringe components and tables that connect syringe capacity to the permitted scale, tolerances and performance limits. Annex C, F and G are informative and give suggested or preparatory methods for piston force, silicone quantity and particulate sampling.

SLOVENSKI STANDARD
01-februar-2026
Sterilne podkožne injekcijske brizge za enkratno uporabo - 1. del: Injekcijske
brizge za ročno injiciranje (ISO/DIS 7886-1:2025)
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO/DIS
7886-1:2025)
Sterile Einmalspritzen für medizinische Zwecke - Teil 1: Spritzen zum manuellen
Gebrauch (ISO/DIS 7886-1:2025)
Seringues hypodermiques stériles, non réutilisables - Partie 1: Seringues pour utilisation
manuelle (ISO/DIS 7886-1:2025)
Ta slovenski standard je istoveten z: prEN ISO 7886-1
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 7886-1
ISO/TC 84
Sterile hypodermic syringes for
Secretariat: DS
single use —
Voting begins on:
Part 1: 2025-12-01
Syringes for manual use
Voting terminates on:
2026-02-23
Seringues hypodermiques stériles, non réutilisables —
Partie 1: Seringues pour utilisation manuelle
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.
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BEING ACCEPTABLE FOR INDUSTRIAL,
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USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 7886-1:2025(en)
DRAFT
ISO/DIS 7886-1:2025(en)
International
Standard
ISO/DIS 7886-1
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
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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BE CONSIDERED IN THE LIGHT OF THEIR
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Published in Switzerland Reference number
ISO/DIS 7886-1:2025(en)
ii
ISO/DIS 7886-1:2025(en)
Contents Page
Foreword .v
Introduction .vi
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 graduated capacity .8
5.10 Graduated scale . .9
5.10.1 Scale .9
5.10.2 Numbering of scales .10
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 .11
5.11.1 Dead space .11
5.11.2 Freedom from air and liquid leakage past plunger stopper .11
5.11.3 Force to operate the piston .11
5.11.4 Fit of plunger stopper/plunger in barrel .11
5.11.5 Sterility assurance .11
5.11.6 Expelled volume .11
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 . 12
6.2 Multiple unit pack . 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 syringe units or rigid unit packaging . 13
7.3 Unit packaging . 13

iii
ISO/DIS 7886-1:2025(en)
7.4 Multiple unit packs .14
7.4.1 General .14
7.4.2 Multiple unit packs with self-contained syringes . .14
7.5 User packaging .14
7.6 Storage container . 15
7.7 Transport wrapping . . 15
Annex A (normative) Method for preparation of extracts .16
Annex B (normative) Test method for air leakage past syringe plunger stopper during
aspiration, and for separation of plunger stopper and plunger . 17
Annex C (informative) Test method for the determination of forces required to operate the
piston .20
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 .34
Bibliography .36

iv
ISO/DIS 7886-1:2025(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/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 third edition cancels and replaces the second edition (ISO 7886-1:2016), which has been technically
revised.
The main changes to the previous edition are the following:
— xxx xxxxxxx xxx xxxx
Drafting note: New list to be developed by WG 11.
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.

v
ISO/DIS 7886-1:2025(en)
Introduction
The ISO 7886 series cover 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 ISO 7886 (all parts) is given in
ISO/TR 19244.
vi
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
aspiration 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 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
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/

ISO/DIS 7886-1:2025(en)
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 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
scale interval or intervals in graduation line
3.5
multiple unit pack
multiple syringes packaged with a single seal that maintains the sterility of the product
3.6
needle cap or 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 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

ISO/DIS 7886-1:2025(en)
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 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.

ISO/DIS 7886-1:2025(en)
Key
1 needle cap or 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.

ISO/DIS 7886-1:2025(en)
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 comply 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 to IEC 62366-1.
5.2 Material selection
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.
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 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 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 shall 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.
ISO/DIS 7886-1:2025(en)
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 shall 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
or by an inductively coupled plasma mass spectrometry method (ICP).
NOTE The test to 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 evaluation of syringes shall be in compliance to ISO 10993 series.
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.
ISO/DIS 7886-1:2025(en)
For lubricants incorporated in the polymer formulation, the quantity of lubricant shall not exceed 0,6 %
(w/w) of the mass of the component, but attention is drawn to the fact that some national regulations may
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 complying 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 3, 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.
ISO/DIS 7886-1:2025(en)
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.
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 graduated capacity
The tolerances on the graduated capacity shall be as given in Table 1.

ISO/DIS 7886-1:2025(en)
Table 1 — Capacity tolerance, dead space, scale dimensions and test forces
Tolerance on any Forces and pres-
Minimum
graduated capacity sures for leakage
overall Increment
testing
Nominal Maxi-
length of between
(see Annex E)
capacity of mum Scale in-
scale to graduation
syringe dead terval
Less than 20 % Axial
nominal lines to be
Side
Less than half Equal to or
space
nominal capacity pressure
V ml
capacity numbered
force
and more than greater than
ml ml (gauge)
mark
ml
or equal to 20 % half nominal (±5 %)
(±5 %)
mm
nominal capacity capacity
N
kPa
±10 % of expelled ±5 % of
±(1,5 % of V + 2 %
V < 2 volume expelled vol- 0,07 25 0,05 0,1 0,25 300
of expelled volume)
ume
±10 % of expelled ±5 % of
±(1,5 % of V + 2 %
2 ≤ V < 5 volume expelled vol- 0,07 27 0,2 1 1,0 300
of expelled volume)
ume
±10 % of expelled ±4 % of
±(1,5 % of V + 1 %
5 ≤ V < 10 volume expelled vol- 0,075 36 0,5 1 2,0 300
of expelled volume)
ume
±10 % of expelled ±4 % of
±(1,5 % of V + 1 %
10 ≤ V < 20 volume expelled vol- 0,10 44 1,0 5 2,0 300
of expelled volume)
ume
±(1,5 % of V + 1 % ±4 % of
20 ≤ V < 30 of expelled volume) expelled vol- 0,15 52 2,0 10 3,0 200
ume
±(1,5 % of V + 1 % ±4 % of
30 ≤ V < 50 of expelled volume) expelled vol- 0,17 67 2,0 10 3,0 200
ume
±(1,5 % of V + 1 % ±4 % of
V ≥ 50 of expelled volume) expelled vol- 0,20 75 5,0 10 3,0 200
ume
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
V<5
(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;

ISO/DIS 7886-1:2025(en)
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 could be submitted to usability
evaluation according to IEC 62366.
Examples of scales and the numbering of graduation lines are shown in Figure 3.
NOTE 1 The vertical line of the scale may 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 Graduation lines shall be numbered at least at the volume increments given in Table 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 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
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