prEN ISO 7864

SLOVENSKI STANDARD
01-januar-2026
Sterilne podkožne igle za enkratno uporabo - Zahteve in preskusne metode
(ISO/DIS 7864:2025)
Sterile hypodermic needles for single use - Requirements and test methods (ISO/DIS
7864:2025)
Sterile Injektionskanülen für den Einmalgebrauch - Anforderungen und Prüfverfahren
(ISO/DIS 7864:2025)
Aiguilles hypodermiques stériles à usage unique - Exigences et méthodes d'essai
(ISO/DIS 7864:2025)
Ta slovenski standard je istoveten z: prEN ISO 7864
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 7864
ISO/TC 84
Sterile hypodermic needles for
Secretariat: DS
single use — Requirements and test
Voting begins on:
methods
2025-11-25
Aiguilles hypodermiques stériles, non réutilisables — Exigences et
Voting terminates on:
méthodes d'essai
2026-02-17
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 7864:2025(en)
DRAFT
ISO/DIS 7864:2025(en)
International
Standard
ISO/DIS 7864
ISO/TC 84
Sterile hypodermic needles for
Secretariat: DS
single use — Requirements and
Voting begins on:
test methods
Aiguilles hypodermiques stériles, non réutilisables — Exigences et
Voting terminates on:
méthodes d'essai
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
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POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
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NATIONAL REGULATIONS.
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TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
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RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 7864:2025(en)
ii
ISO/DIS 7864:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 3
4.1 General .3
4.2 Statistics and reproducibility of test methods .3
4.3 Cleanliness .3
4.4 Limits for acidity or alkalinity .3
4.5 Limits for extractable metals .3
4.6 Size designation .3
4.6.1 Tubular needle designation .3
4.6.2 Tapered needle designation .3
4.6.3 Permanently coated needles .4
4.7 Colour coding .4
4.8 Needle hub .4
4.9 Needle cap . .4
4.10 Needle tube .5
4.10.1 General .5
4.10.2 Length tolerances .5
4.10.3 Freedom from defects .6
4.10.4 Lubrication .6
4.10.5 Coating.6
4.11 Needle point .6
4.12 Bond between hub and needle tube .7
4.13 Flow of the needle .8
4.13.1 General .8
4.13.2 Labelling .9
4.14 Sharps injury protection .9
4.15 Sterility and biocompatibility .9
4.15.1 Sterility .9
4.15.2 Biocompatibility .9
5 Packaging. 9
5.1 Unit packaging .9
5.2 User packaging .10
6 Information supplied by the manufacturer . 10
6.1 General .10
6.2 Specific labelling requirements to hypodermic needles .10
6.3 Storage container .10
6.4 Transport wrapping . .11
Annex A (normative) Method for preparation of extracts .12
Annex B (informative) Fragmentation test for medical needles .13
Annex C (normative) Determination of flow rate through the needle .15
Annex D (informative) Test method for measuring the penetration force and friction force for
needles . 17
Annex E (informative) Needle bonding strength test method .23
Bibliography .25

iii
ISO/DIS 7864:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and catheters.
This fifth edition cancels and replaces the fourth edition (ISO 7864:2016), which has been technically
revised.
The main changes are as follows:
— Harmonized designated sizes with ISO 9626;
— Included term and explanation for coating, lubrication and non-permanent coating;
— Harmonized illumination requirements for tests 4.3 based on relevant standards;
— Changed size designation from inner diameter to flow rate;
— Updated colour coding;
— Updated length tolerance;
— Updated requirement for bonding between hub and needle tube;
— Combined patency of lumen with flow properties;
— Updated Annex D Test method of measuring the penetration force and friction force for needle.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
ISO/DIS 7864:2025(en)
Introduction
This document covers sterile hypodermic needles for single use intended to inject or withdraw fluids from
primarily the human body.
Plastics materials to be used for the construction of needles are not specified, as their selection will depend
to some extent upon the design, process of manufacture and method of sterilization employed by individual
manufacturers.
Hypodermic needles specified in this document are intended for use with syringes having a 6 % Luer conical
fitting as specified in ISO 80369-7 in conjunction with ISO 80369-1 and ISO 80369-20.
Devices/connectors intended to mate with hypodermic needles of the document, but which deviate from
ISO 80369-7 shall provide demonstrated evidence of safe functional performance.
Guidance on transition periods for implementing the requirements of this document is given in ISO/TR 19244.

v
DRAFT International Standard ISO/DIS 7864:2025(en)
Sterile hypodermic needles for single use — Requirements
and test methods
1 Scope
This document specifies requirements for sterile hypodermic needles for single use of designated metric
sizes 0,18 mm to 3,4 mm.
It does not apply to those devices that are covered by their own standard such as dental needles and pen
needles.
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 6009, Hypodermic needles for single use — Colour coding for identification
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and times
1)
ISO 9626:xxxx , Stainless steel needle tubing for the manufacture of medical devices — Requirements and
test methods
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 14971, Medical devices — Application of risk management to medical devices
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 80369-1, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General
requirements
ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for
neural applications
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for
intravascular or hypodermic applications
ISO 15223-1:2021, Medical devices — Symbols to be used with information to be supplied by the manufacturer
— Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
1) Currently subject to revision (to be submitted as DIS in October 2025)

ISO/DIS 7864:2025(en)
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
coating
measurable layer of material added onto the outer surface of the needle that is intended to be permanent
and not come off during use
Note 1 to entry: The purpose of applying the coating may be decorative, functional (e.g. improve electrical connectivity,
reduce friction etc.) or both.
3.2
gauge
legacy size designation; a particular gauge size corresponds to a designated metric size defining limits for
outer diameters
3.3
lubrication
application of a liquid coating or solid coating intended to reduce friction and wear between two elements
that move relative to each other (e.g. needle and skin or other substrates into which the needle is inserted)
3.4
needle cap
cover intended to physically protect the needle tube (3.6) prior to use
3.5
needle hub
tbd
Drafting note: Proposals for definition requested during enquiry procedure.
3.6
needle tube
tbd
Drafting note: Proposals for definition requested during enquiry procedure.
3.7
non-permanent coating
substance applied to the surface of a needle that can be removed by normal use of the needle
Note 1 to entry: Liquid lubricant such as silicone.
3.8
tapered needle
needle with conical needle tube which has an outer diameter spanning at least two consecutive designated
metric sizes
3.9
unit packaging
packaging of an individual device, intended to maintain its sterility
3.10
user packaging
packaging, which contains one or more items of unit packaging (3.9), designed to provide labelling
information to the user
ISO/DIS 7864:2025(en)
4 Requirements
4.1 General
Testing finished products shall be conducted on sterilized products.
4.2 Statistics and reproducibility of test methods
Any suitable test system can be used when the required accuracy (calibration) and precision [Gauge
repeatability and reproducibility (R&R)] can be obtained.
4.3 Cleanliness
When inspected by normal or corrected-to-normal vision under an illuminance of min. 500 lx, the surface of
the hypodermic needle tube shall appear free from particles and extraneous matter.
When examined under 2,5× magnification, the hub socket (fluid path surface) shall appear free from
particles and extraneous matter.
4.4 Limits for acidity or alkalinity
When determined with a laboratory pH meter and using a general purpose electrode, the pH value of an
extract prepared in accordance with Annex A shall be within one unit of pH of that of the control fluid.
4.5 Limits for extractable metals
When tested by a recognized microanalytical method, for example by an atomic absorption method, an
extract prepared in accordance with Annex A shall, when corrected for the metals content of the control
fluid, contain not greater than a combined total of 5 mg/l of lead, tin, zinc, and iron. The cadmium content of
the extract shall, when corrected for the cadmium content of the control fluid, be lower than 0,1 mg/l.
4.6 Size designation
4.6.1 Tubular needle designation
The size of the hypodermic needle shall be designated by the following:
a) the designated metric size of the needle tube, may also be expressed in millimetres
— considering the regional distribution of the products, optionally the needle size expressed in gauge size;
b) the length of the needle tube, expressed in millimetres (Figure 2).
EXAMPLE 0,8 mm x 40 mm.
4.6.2 Tapered needle designation
Details necessary for the user to identify the needle, including the designated metric size, shall be provided
in accordance with the following expression:

ISO/DIS 7864:2025(en)
OD t()ip /OD ()hub ×L
where
OD (tip) is the designated metric size of the needle tube at the first full diameter from the tip (measuring
point 2, at the end of the bevel geometry as shown in Figure 1) expressed in millimetres;
OD(hub) is the designated metric size of the needle tube at the hub side, measured at the first full
diameter from the top of the hub or from the top of the jointing medium, if used, (measuring
point 1 at the end of the hub geometry as shown in Figure 1) expressed in millimetres;
L is the nominal length of the needle tube, expressed in millimetres (Figure 2).
EXAMPLE 0,23 mm/0,25 mm × 6 mm.
Key
1 OD. (hub)
2 OD. (tip)
Figure 1 — Tapered needle designation
4.6.3 Permanently coated needles
The size of the hypodermic needle shall be labelled with the measurement after coating.
EXAMPLE 0,8 mm × 40 mm.
4.7 Colour coding
If colour coding is used, it shall be in accordance with ISO 6009.
The designated metric size of hypodermic tubular needles or the first full diameter from the tip of a tapered
needle shall be used.
4.8 Needle hub
The conical socket of the hypodermic needle hub shall meet the requirements of ISO 80369-1 and
ISO 80369-6, and/or ISO 80369-1 and ISO 80369-7.
4.9 Needle cap
If a separate needle cap is provided, it shall be made either of pigmented or of unpigmented material. If
pigmented, the colour shall be in accordance with ISO 6009.

ISO/DIS 7864:2025(en)
a)
b)
Key
1 hub
2 jointing medium (if applicable)
3 needle tube
4 needle cap
5 length
a) safety system
b) foam
NOTE Figure 2 represents a typical configuration of a hypodermic needle. Specific designs can vary based on the
packaging design of the manufacturer.
Figure 2 — Example of a typical hypodermic needle and needle cap for single use
4.10 Needle tube
4.10.1 General
Needles according to the tubular needle designation shall be in accordance with ISO 9626. For tapered
needles, manufacturers shall define how to apply the functional tests specifically stiffness and resistance to
breakage on the basis of specifications for at least the minimum designated dimension of the tapered needle
going into the patient. Justification of the chosen testing specification shall be made.
4.10.2 Length tolerances
The length of the needle tube (see dimension L in Figure 2) shall equal the nominal length within the
tolerances given in Table 1.
ISO/DIS 7864:2025(en)
Table 1 — Needle tube length tolerances
Dimensions in millimetres
Length of needle tube Tolerance
<25 +1
-2
≥25 +1,5
-2,5
Smaller tolerance for very short needles based on the intended use should be considered.
4.10.3 Freedom from defects
When inspected by normal or corrected-to-normal vision without magnification under an illuminance of
min 500 lx, the outer surface of the tubing shall be smooth and free from defects.
4.10.4 Lubrication
The needle can be surface-treated using a lubricant (e.g. silicone oil) to minimize pain when the needle
penetrates, for example, the skin during the injection.
If the hypodermic needle tube has a lubrication, it shall not be visible as droplets of fluid on the outer or
inner surfaces of the needle tube under normal or corrected vision of the naked eye.
Penetration testing e.g. see Annex D can provide an indication of the acceptable lubrication.
NOTE 1 The impact to the outer diameter of a lubrication is negligible. The impact to the inner diameter can be
detected within 4.13 or Annex C.
NOTE 2 An acceptable lubricant is silicone complying with a national or the European Pharmacopoeia and
ISO 10993-1.
NOTE 3 The amount of lubricant should be minimized.
4.10.5 Coating
If the hypodermic needle is provided with a coating that is intended to be permanent, there may be an
impact to the outer diameter. The impact on the outer diameter sh
...