kSIST FprEN ISO 7886-1:2026

• 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
• Public Enquiry End Date: 22-Feb-2026
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 02-Nov-2026
• Due Date: 21-Dec-2026
• Completion Date: 03-Nov-2026
• Ref Project: FprEN ISO 7886-1 - Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO/FDIS 7886-1:2026)

• Revises: SIST 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

kSIST FprEN ISO 7886-1:2026 is a SIST standard for sterile hypodermic syringes for single use, Part 1: syringes for manual use. It specifies requirements and test methods for empty sterile syringes, with or without needle, that are filled by the end user and used mainly in humans. The document also covers packaging and manufacturer information, and it excludes insulin syringes, glass syringes, syringes for power-driven syringe pumps, pre-filled syringes, and syringes intended to be stored after filling.

What does kSIST FprEN ISO 7886-1:2026 specify?

kSIST FprEN ISO 7886-1:2026 sets out how to verify the design of sterile single-use hypodermic syringes for manual use. It is written for syringe designs that are filled immediately before use, rather than stored after filling.

The document is organized into clauses on scope, normative references, terms and definitions, nomenclature, requirements, packaging, and information supplied by the manufacturer.

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

The scope also states that syringes without a needle are intended for use with hypodermic needles specified in ISO 7864. That matters in practice because the syringe and needle have to work together as a system.

What are the key requirements of kSIST FprEN ISO 7886-1:2026?

kSIST FprEN ISO 7886-1:2026 focuses on design performance, cleanliness, packaging, and information for safe use. The requirements are written as design and verification points for manufacturers, not as lot-release rules.

Design, usability, and materials

Clause 5.1 requires syringes to be free from defects that could affect appearance, safety, or performance. It also requires syringes with integrated or add-on sharps protection to comply with ISO 23908, and it expects barrel flanges to be sized and shaped through risk analysis and usability engineering.

Clause 5.2 requires material choices that support the intended use, including clarity of the barrel so the user can read dosages under normal or corrected vision and low lighting. In practice, this means the barrel markings must stay readable in realistic use conditions, not only in ideal laboratory lighting.

Cleanliness, biocompatibility, and extractables

Clause 5.3 requires the fluid-contacting surfaces to be free from particles and extraneous matter on visual inspection. It also controls acidity or alkalinity, extractable metals, pyrogenicity, biocompatibility, and particulate contamination, with Annex A used to prepare extracts.

This section matters because the syringe is a medical fluid path. Manufacturers have to show that materials and manufacturing cleanliness do not introduce unacceptable contaminants into the injected fluid.

Lubricant and particulate control

Clause 5.4 limits lubricant on the interior surface and also limits lubricant incorporated into the polymer formulation. The document also points users to Annex F for a silicone quantity test.

Clause 5.3.6 sets particulate expectations for sterilized syringes and links sample preparation to Annex G. In practice, the manufacturer needs to control moulding, handling, sterilization, and packaging so particulate contamination stays low.

Dimensions, nozzle, and scale

Clauses 5.5, 5.6, 5.7, 5.9, and 5.10 cover the physical design of the barrel, flanges, plunger stopper/plunger assembly, nozzle, and graduated scale. The nozzle connection has to comply with ISO 80369-7, and the scale has to be numbered and laid out consistently with the nominal and total graduated capacity.

This matters because the user relies on the syringe to connect correctly, fill accurately, and deliver a readable dose. Clause 5.10 also requires the scale to remain legible after the fastness test in Annex I.

Functional performance and sterility

Clause 5.11 requires control of dead space, no leakage past the plunger stopper, suitable operating force, correct fit in the barrel, sterility assurance, and expelled volume. Annex D, Annex E, and Annex H provide the methods for those checks.

The practical effect is that the syringe has to move smoothly, retain fluid when needed, deliver the intended volume, and keep sterility through the packaged shelf life. The document also requires a validated sterilization process that achieves a Sterility Assurance Level (SAL) of 10^-6.

Packaging and labeling

Clauses 6 and 7 require unit packaging, multiple unit packs, and user packaging to protect sterility during handling, transit, and storage. They also require markings such as sterile status, single-use identification, batch or lot identification, contents identification, use-by information, and manufacturer identification, with additional markings for self-contained syringe units and dead-space variants.

In practice, the packaging system has to protect the sterile barrier and make opening damage visible. The markings have to give users the information they need without making the graduated scale hard to read.

What terms does kSIST FprEN ISO 7886-1:2026 define?

• Dead space - the volume of liquid left in the syringe when the plunger stopper is fully depressed during normal use.
• Nominal capacity - the capacity designated by the manufacturer for the syringe.
• Total graduated capacity - the capacity at the graduation line furthest from the zero graduation line.
• Fiducial line - the leading edge on the plunger stopper that aligns with the zero marking when the piston is fully inserted.
• Multiple unit pack - multiple syringes packaged under a single seal that keeps the product sterile.
• Self-contained syringe - a syringe with protective end caps intended to maintain the sterility of the interior of the syringe.
• Unit packaging - packaging that directly contacts the device and maintains sterility.
• Plunger stopper - the component on the leading end of the plunger that seals the open end of the barrel.

Who uses kSIST FprEN ISO 7886-1:2026?

kSIST FprEN ISO 7886-1:2026 is used by syringe manufacturers, medical device designers, quality teams, test laboratories, and regulatory or conformity-assessment staff. It is also relevant to buyers and product engineers who need to specify or verify sterile single-use syringes for human use.

The document is especially relevant where design verification, packaging validation, labeling, and bench testing have to be tied together. That includes syringe production, sterile medical device packaging, and related needle-connector compatibility work.

What changed in kSIST FprEN ISO 7886-1:2026 from the previous edition?

kSIST FprEN ISO 7886-1:2026 replaces the second edition, ISO 7886-1:2016. The foreword states that this third edition has been technically revised.

Which standards are used with kSIST FprEN ISO 7886-1:2026?

• ISO 3696 - provides the water quality used in extraction and several test methods.
• ISO 15223-1:2021 - provides the symbols used on labels and packaging.
• ISO 23908 - applies where the syringe includes sharps protection.
• ISO 80369-7 - governs the small-bore connector interface for the nozzle and is also used in test fittings.
• ISO 7864 - gives the needle standard referenced for syringes supplied without a needle.
• ISO 10993 series - supports the biocompatibility evaluation required for syringe materials.
• ISO 14971 - supports risk assessment for design features such as finger grips and scale variation.
• IEC 62366-1 - supports usability engineering for readable scales and safe handling.
• ISO 8655-6 - is referenced in Annex H for the gravimetric measurement setup used to determine expelled volume.
• ISO 11607-1 and ISO 11607-2 - are relevant packaging references listed in the bibliography for sterile barrier systems and packaging validation.

What does the kSIST FprEN ISO 7886-1:2026 document contain?

The document contains a schematic nomenclature figure for syringe components, a requirements table linking capacity to tolerance, dead space, scale dimensions, and test forces, and a second table defining dead space categories for smaller capacities. It also includes test methods for extraction, leakage, piston force, dead space, leakage under compression, silicone quantity, particulate sample preparation, expelled volume, and scale fastness.

Several annexes use laboratory apparatus and measurement steps, including vacuum testing, weighing, gravimetric volume determination, and tape-and-solvent marking durability checks. Annex C gives a proposed force-measurement method, Annex G gives particle-count calculations, and Annex H gives a formula-based method for converting expelled mass to delivered volume at a reference temperature.

SLOVENSKI STANDARD
oSIST prEN ISO 7886-1:2026
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
oSIST prEN ISO 7886-1:2026 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 7886-1:2026
oSIST prEN ISO 7886-1:2026
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.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
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)
oSIST prEN ISO 7886-1:2026
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
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 7886-1:2025(en)
ii
oSIST prEN ISO 7886-1:2026
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
oSIST prEN ISO 7886-1:2026
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
oSIST prEN ISO 7886-1:2026
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
oSIST prEN ISO 7886-1:2026
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
oSIST prEN ISO 7886-1:2026
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/

oSIST prEN ISO 7886-1:2026
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

oSIST prEN ISO 7886-1:2026
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.

oSIST prEN ISO 7886-1:2026
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.

oSIST prEN ISO 7886-1:2026
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.
oSIST prEN ISO 7886-1:2026
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.
oSIST prEN ISO 7886-1:2026
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.
oSIST prEN ISO 7886-1:2026
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.

oSIST prEN ISO 7886-1:2026
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;

oSIST prEN ISO 7886-1:2026
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
...