prEN ISO 9626

SLOVENSKI STANDARD
01-januar-2026
Igle iz nerjavnega jekla za izdelavo medicinskih pripomočkov - Zahteve in
preskusne metode (ISO/DIS 9626:2025)
Stainless steel needle tubing for the manufacture of medical devices - Requirements and
test methods (ISO/DIS 9626:2025)
Kanülenrohre aus nichtrostendem Stahl zur Herstellung von Medizinprodukten -
Anforderungen und Prüfverfahren (ISO/DIS 9626:2025)
Tubes d'aiguilles en acier inoxydable pour la fabrication de dispositifs médicaux -
Exigences et méthodes d'essai (ISO/DIS 9626:2025)
Ta slovenski standard je istoveten z: prEN ISO 9626
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 9626
ISO/TC 84
Stainless steel needle tubing for the
Secretariat: DS
manufacture of medical devices —
Voting begins on:
Requirements and test methods
2025-11-24
Tubes d'aiguilles en acier inoxydable pour la fabrication de
Voting terminates on:
matériel médical — Exigences et méthodes d'essai
2026-02-16
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 9626:2025(en)
DRAFT
ISO/DIS 9626:2025(en)
International
Standard
ISO/DIS 9626
ISO/TC 84
Stainless steel needle tubing for the
Secretariat: DS
manufacture of medical devices —
Voting begins on:
Requirements and test methods
Tubes d'aiguilles en acier inoxydable pour la fabrication de
Voting terminates on:
matériel médical — Exigences et 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
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: +41 22 749 01 11
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 9626:2025(en)
ii
ISO/DIS 9626:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Materials . 2
5 Requirements . 2
5.1 General .2
5.2 Statistics and reproducibility of test methods .2
5.3 Surface finish and visual appearance .2
5.4 Cleanliness .2
5.5 Limits for acidity and alkalinity .2
5.6 Size designation .2
5.7 Dimensions .2
5.8 Sample size .3
5.9 Stiffness .3
5.10 Resistance to breakage .5
5.11 Resistance to corrosion .5
Annex A (normative) Methods for preparation of extracts . 6
Annex B (normative) Test method for stiffness of tubing . 7
Annex C (normative) Test method for resistance of tubing to breakage . 9
Annex D (normative) Test method for resistance to corrosion .12
Annex E (informative) Rationale with respect to test method for stiffness of tubing .13
Bibliography .22

iii
ISO/DIS 9626:2025(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 84, Devices for administration of medicinal products
and catheters.
This third edition cancels and replaces the second edition (ISO 9626:2016), which has been technically
revised.
The main changes are as follows:
— included requirement statistics and reproducibility of test methods as mentioned in ISO 7864;
— harmonized illumination requirements for tests 5.3 and 5.4 based on relevant standards;
— closed gaps in dimensions of tubings (Table 1);
— defined visible breakage;
— re-defined Annex C (Test method for resistance of tubing to breakage);
— deleted RW=Regular Wall, TW=Thin Wall, ETW= Extra Thin Wall, and UTW=Ultra-Thin Wall.
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 9626:2025(en)
Introduction
Guidance on transition periods for implementing the requirements of this document is given in ISO/TR 19244.

v
DRAFT International Standard ISO/DIS 9626:2025(en)
Stainless steel needle tubing for the manufacture of medical
devices — Requirements and test methods
1 Scope
This document applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic
needles and other medical devices primarily for human use.
This document provides requirements and test methods for the tubes manufactured for needles as
component used in medical devices. Additional performance testing on the tube aspect may be required
when the component is incorporated in the ready-to-use device.
This document specifies the dimensions and mechanical properties of steel tubing of designated metric
sizes 3,4 mm (10 Gauge) to 0,18 mm (34 Gauge).
It does not apply to flexible stainless steel tubing because the mechanical properties differ from those
specified for rigid tubing in this document. However, manufacturers and purchasers of flexible tubing are
encouraged to adopt the dimensional specifications given in this document.
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 15510, Stainless steels — Chemical composition
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
designated metric size
outer diameter designation of the tubing as defined in Table 1
Note 1 to entry: It is expressed in millimetres.
3.2
gauge
legacy size designation; a particular gauge size corresponds to a designated metric size defining limits for
outer diameters.
3.3
wall thickness
material thickness between the inner and outer diameter of the tube

ISO/DIS 9626:2025(en)
4 Materials
Tubing shall be made of stainless steels listed in ISO 15510. The chosen materials shall be in accordance with
the requirements indicated in this document. Selection of specific stainless steel material shall be made in
consideration with the intended use, e.g. long-term contact with drugs and should consider biocompatibility
requirements.
NOTE Suitable biocompatibility requirements can be found in ISO 10993-1.
5 Requirements
5.1 General
For the selection of tubing for a specific application and intended use, a risk-based approach shall be applied.
5.2 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.
5.3 Surface finish and visual appearance
When examined by normal or corrected vision, under an illuminance of min. 500 lx, the outside surface of
the tubing shall be smooth and free from defects.
Surface finish specifications may be different based on the final function of the medical device; in such cases,
the medical device manufacturer should prepare specific specifications for surface finishing.
When examined by normal or corrected vision, the needle tube shall appear straight and of regular
roundness.
5.4 Cleanliness
When examined by normal or corrected vision, under an illuminance of min. 500 lx, the surfaces of the
tubing shall be free from metal soil and processing agents.
Cleanliness specifications may be different based on the final function of the medical device; in such cases,
the medical device manufacturer should prepare specific specifications for cleanliness.
5.5 Limits for acidity and 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 pH unit of that of the control fluid.
5.6 Size designation
Tubing size shall be designated by the nominal outer diameter, expressed in millimetres (i.e. the designated
metric size), corresponding gauge size (e.g. G31 or 31G).
EXAMPLE 0,25 mm (31G).
5.7 Dimensions
The outer diameter of the needle shall be OD ≥ OD and OD < OD such that there will be no overlap in
MIN MAX
the designated sizes given in Table 1. The inner diameter of the needle shall be ID ≥ ID .
MIN
This document does not specify maximum inner diameter.

ISO/DIS 9626:2025(en)
Table 1 — Dimensions of tubing
Designated metric size OD OD ID
MIN MAX MIN
Gauge
mm mm mm mm
0,18 34 0,170 0,190 0,064
0,20 33 0,190 0,220 0,089
0,23 32 0,220 0,250 0,089
0,25 31 0,250 0,280 0,114
0,30 30 0,280 0,320 0,133
0,33 29 0,320 0,350 0,133
0,36 28 0,350 0,380 0,133
0,40 27 0,380 0,430 0,184
0,45 26 0,430 0,480 0,232
0,50 25 0,480 0,530 0,232
0,55 24 0,530 0,580 0,280
0,60 23 0,580 0,680 0,317
0,70 22 0,680 0,750 0,390
0,80 21 0,750 0,850 0,490
0,90 20 0,850 0,950 0,560
1,10 19 0,950 1,150 0,648
1,20 18 1,150 1,350 0,790
1,40 17 1,350 1,550 0,950
1,60 16 1,550 1,700 1,100
1,80 15 1,700 1,900 1,300
2,10 14 1,900 2,200 1,500
2,40 13 2,200 2,500 1,700
2,70 12 2,500 2,850 1,950
3,00 11 2,850 3,200 2,200
3,40 10 3,200 3,600 2,500
NOTE OD = outer diameter; ID = inner diameter.
5.8 Sample size
Where sampling is applicable, the sample sizes shall be determined on the basis of risk assessment principles
and be included in the tube specification and based on the intended use.
5.9 Stiffness
When tested in accordance with Annex B, the tubing shall show a deflection not greater than the relevant
value given in Table 2.
For tubes where stiffness test parameters are not defined in this document, the medical device manufacturer
shall prepare specific stiffness requirements based on a risk assessment of the final intended use of the tube.
Consideration should be given to the final product intended use of the tube to determine if additional tests
are required.
NOTE The data in Table 2 was collected on real measurements, further information for evaluation of additional
stiffness test parameters is provided in Annex E.

ISO/DIS 9626:2025(en)
Table 2 — Conditions for stiffness test
Designated Span Bending force Ref. ID. Maximum deflection Ref. ID. Maximum deflection Ref. ID. Maximum deflection Ref. ID. Maximum deflection
metric size mm ± 0,1 N ± 0,1 mm mm mm mm mm mm mm mm
a a a a a a a a a a
0,18
a a a a
0,2 5,0 0,6 0,089 0,25 0,105 0,27
0,23 5,0 0,9 0,089 0,20 0,105 0,20 0,125 0,22 0,146 0,25
0,25 5,0 1,1 0,114 0,17 0,125 0,18 0,146 0,21 0,176 0,24
0,3 5,0 1,3 0,133 0,11 0,165 0,11 0,190 0,16 0,240 0,20
0,33 5,0 1,6 0,133 0,09 0,190 0,12 0,240 0,17 0,265 0,19
a a a a
0,36 5,0 3,6 0,133 0,14 0,190 0,14
b a a a a
0,4 9,5 2,7 0,184 0,52 0,241 0,34
a a a a
0,45 10,0 3,1 0,232 0,45 0,292 0,51
a a a a
0,5 10,0 5,1 0,232 0,37 0,292 0,40
a a a a
0,55 10,0 6,4 0,280 0,34 0,343 0,36
a a
0,6 12,5 4,8 0,317 0,33 0,370 0,43 0,460 0,51
a a
0,7 15,0 6,7 0,390 0,42 0,440 0,52 0,522 0,60
a a
0,8 15,0 9,6 0,490 0,38 0,547 0,45 0,610 0,51
a a
0,9 17,5 9,0 0,560 0,48 0,635 0,56 0,687 0,60
a a
1,1 25,0 9,7 0,648 0,71 0,750 0,97 0,850 1,08
a a a a
1,2 25,0 12,2 0,790 0,51 0,910 0,81
a a
1,4 25,0 16,6 0,950 0,46 1,156 0,68 1,244 0,82
a a
1,6 25,0 22,0 1,100 0,25 1,283 0,30 1,390 0,34
a a a a
1,8 25,0 25,0 1,300 0,35 1,460 0,45
a a a a
2,1 30,0 40,0 1,500 0,40 1,600 0,50
a a a a
2,4 40,0 40,0 1,700 0,38 1,956 0,65
a a a a
2,7 40,0 50,0 1,950 0,31 2,235 0,45
a a a a
3 50,0 50,0 2,200 0,41 2,464 0,55
a a a a
3,4 50,0 60,0 2,500 0,32 2,819 0,46
a
No data is available; therefore, this document does not specify stiffness properties for these sizes of tubing.
b
Span 7,5 mm ± 0,1, Bending force 3,4 N ± 0,1

ISO/DIS 9626:2025(en)
5.10 Resistance to breakage
When tested in accordance with Annex C, the tubing shall not break (breakage is defined as the separation
of the tube under test into two separate parts).
NOTE Consideration can be given to the final product’s intended use to determine if additional tests are
warranted.
5.11 Resistance to corrosion
When tested in accordance with Annex D, the immersed half of the tubing shall show no evidence of corrosion
resulting from the test.
NOTE Consideration can be given to the final product’s intended use to determine if additional tests are
warranted, e.g. long-term drug product contact.

ISO/DIS 9626:2025(en)
Annex A
(normative)
Methods for preparation of extracts
A.1 Principle
The stainless steel tubing is immersed in water in order to extract soluble components.
A.2 Apparatus and reagents
A.2.1 Freshly distilled or deionized water, of grade 3 in accordance with ISO 3696.
A.2.2 Selection of laboratory borosilicate glassware.
A.3 Procedure
A.3.1 Immerse 3 g of tubing in 250 ml of water (A.2.1) in a suitable container made from borosilicate glass
(A.2.2). Ensure that the surface of the stainless tubing, including the inside of the tubing, is in contact with
the water.
 
Maintain the water at a temperature of 37+ °C for (60 ± 2) min. Remove the tubing and ensure that all
 
 
water from the inside and outside surfaces of the tubing are returned to the container.
A.3.2 Prepare the control fluid by following the procedure given in A.3.1 but omitting the tubing.

ISO/DIS 9626:2025(en)
Annex B
(normative)
Test method for stiffness of tubing
B.1 Principle
A specified force is applied to the centre of the specified length of tubing, which is supported at both ends,
and the amount of deflection measured.
B.2 Apparatus
B.2.1 Stiffness testing apparatus, capable of applying a force of up to 60 N downwards normal to the
tubing with an accuracy of ±0,1 N, by means of a plunger having a lower end in the form of a blunt wedge
formed by two plane surfaces inclined at 60° to one another and a cylindrical surface of radius of 1 mm and
length at least 5 mm.
An example of a suitable apparatus is illustrated in Figure B.1.
B.2.2 Equipment, capable of measuring the deflection of the tubing to the nearest 0,01 mm.
Key
1 span
2 section A-A
3 see detail 4
4 detail
Figure B.1 — Apparatus for stiffness test
B.3 Procedure
B.3.1 Place the tubing on the stiffness testing apparatus (B.2.1) and adjust the tubing and the stiffness
testing apparatus so that:
a) span is as given in Table 2 for the designated metric size of the tubing;

ISO/DIS 9626:2025(en)
b) the bottom surface of the plunger is at the centre of the span; and
c) the tubing is normal to the supporting members and the loading plunger, and the centre of the tubing is
at the centre of the span.
B.3.2 Apply a downward force given in Table 2 for the designated metric size of the tubing at a speed
between 1 mm/min and 10 mm/min.
B.3.3 Measure and record (B.2.2) to the nearest 0,01 mm the deflection of the tubing at the point of
application of the force.
B.4 Test report
The test report shall contain at least the following information:
a) the identity and designated metric size of the tubing;
b) the reference inner diameter of the tube in accordance with Table 2;
c) the measured deflection, expressed in millimetres
...