Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)

ISO 9626:2016 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use.
It 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.
It 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 ISO 9626:2016. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in ISO 9626:2016.

Kanülenrohre aus nichtrostendem Stahl zur Herstellung von Medizinprodukten - Anforderungen und Prüfverfahren (ISO 9626:2016)

Die vorliegende Internationale Norm gilt für biegesteife Kanülenrohre aus nichtrostendem Stahl zur Herstellung von Injektionskanülen und anderen Medizinprodukten, vorwiegend für die Anwendung am Menschen.
Diese Internationale Norm enthält Anforderungen an und Prüfverfahren für Rohre, die in Form von Kanülen für den Einsatz als Komponenten in Medizinprodukten hergestellt werden. Eine zusätzliche Leistungsprüfung der Rohre kann erforderlich werden, wenn die Komponente in das gebrauchsfertige Produkt integriert wird.
Diese Internationale Norm legt die Maße und mechanischen Eigenschaften von Kanülenrohren aus Stahl der metrischen Nenngrößen von 3,4 mm (10 Gauge) bis 0,18 mm (34 Gauge) fest.
Sie gilt nicht für flexible Kanülenrohre aus nichtrostendem Stahl, da deren mechanische Eigenschaften von den in dieser Internationalen Norm für biegesteife Rohre festgelegten Eigenschaften abweichen. Hersteller und Käufer von flexiblen Kanülenrohren sind jedoch angehalten, die maßbezogenen Spezifikationen dieser Internationalen Norm anzuwenden.

Tubes d'aiguilles en acier inoxydable pour la fabrication de matériel médical - Exigences et méthodes d'essai (ISO 9626:2016)

L'ISO 9626 :2016 est applicable aux tubes d'aiguilles rigides en acier inoxydable pouvant être utilisés dans la fabrication des aiguilles hypodermiques et d'autres dispositifs médicaux principalement à usage humain.
Elle prescrit des exigences et des méthodes d'essai s'appliquant aux tubes utilisés pour la fabrication d'aiguilles de dispositifs médicaux. Des essais de performance complémentaires concernant l'aspect du tube peuvent être requis lorsque l'élément est intégré dans le dispositif prêt à l'emploi.
Elle prescrit les dimensions et les propriétés mécaniques des tubes en acier de dimensions théoriques 3,4 mm (10 ga) à 0,18 mm (34 ga).
Elle n'est pas applicable aux tubes flexibles en acier inoxydable du fait que leurs propriétés mécaniques diffèrent de celles prescrites pour les tubes rigides dans l'ISO 9626 :2016. Toutefois, les fabricants et acheteurs de tubes flexibles sont invités à adopter les spécifications dimensionnelles indiquées dans l'ISO 9626 :2016.

Igle iz nerjavnega jekla za izdelavo medicinskih pripomočkov - Zahteve in preskusne metode (ISO 9626:2016)

Ta mednarodni standard se uporablja za toge nerjavne cevi za igle, primerne za uporabo pri izdelavi podkožnih igel in drugih medicinskih pripomočkov predvsem za uporabo pri ljudeh.
Ta mednarodni standard določa zahteve in preskusne metode za cevi, izdelane za igle kot komponente, uporabljene pri medicinskih pripomočkih. Dodatno preskušanje zmogljivosti cevi se lahko zahteva, ko je komponenta dodana v napravo, pripravljeno za uporabo.
Ta mednarodni standard določa mere in mehanske lastnosti nerjavnih cevi
z metrično označbo velikosti od 3,4 mm (10 gauge) do 0,18 mm (34 gauge).
Ne uporablja se za prožne nerjavne cevi, ker se njihove mehanske lastnosti razlikujejo od tistih, določenih za toge cevi v tem standardu. Kljub temu se proizvajalce in kupce prožnih cevi spodbuja, da sprejmejo dimenzijske specifikacije, določene v tem mednarodnem standardu.

General Information

Status
Published
Publication Date
30-Aug-2016
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
31-Aug-2016
Completion Date
31-Aug-2016

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SLOVENSKI STANDARD
SIST EN ISO 9626:2016
01-november-2016
1DGRPHãþD
SIST EN ISO 9626:2000
SIST EN ISO 9626:2000/A1:2002
,JOHL]QHUMDYQHJDMHNOD]DL]GHODYRPHGLFLQVNLKSULSRPRþNRY=DKWHYHLQ
SUHVNXVQHPHWRGH ,62

Stainless steel needle tubing for the manufacture of medical devices - Requirements and

test methods (ISO 9626:2016)
Kanülenrohre aus nichtrostendem Stahl zur Herstellung von Medizinprodukten (ISO
9626:2016)

Tubes d'aiguilles en acier inoxydable pour la fabrication de matériel médical - Exigences

et méthodes d'essai (ISO 9626:2016)
Ta slovenski standard je istoveten z: EN ISO 9626:2016
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 9626:2016 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 9626:2016
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SIST EN ISO 9626:2016
EN ISO 9626
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2016
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 9626:1995
English Version
Stainless steel needle tubing for the manufacture of
medical devices - Requirements and test methods (ISO
9626:2016)

Tubes d'aiguilles en acier inoxydable pour la Kanülenrohre aus nichtrostendem Stahl zur

fabrication de matériel médical - Exigences et Herstellung von Medizinprodukten - Anforderungen

méthodes d'essai (ISO 9626:2016) und Prüfverfahren (ISO 9626:2016)
This European Standard was approved by CEN on 12 June 2016.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9626:2016 E

worldwide for CEN national Members.
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SIST EN ISO 9626:2016
EN ISO 9626:2016 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 9626:2016
EN ISO 9626:2016 (E)
European foreword

This document (EN ISO 9626:2016) has been prepared by Technical Committee ISO/TC 84 "Devices for

administration of medicinal products and catheters" in collaboration with Technical Committee

CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by February 2017, and conflicting national standards

shall be withdrawn at the latest by February 2017.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent

rights.
This document supersedes EN ISO 9626:1995.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 9626:2016 has been approved by CEN as EN ISO 9626:2016 without any modification.

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SIST EN ISO 9626:2016
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SIST EN ISO 9626:2016
INTERNATIONAL ISO
STANDARD 9626
Second edition
2016-08-01
Stainless steel needle tubing for the
manufacture of medical devices —
Requirements and test methods
Tubes d’aiguilles en acier inoxydable pour la fabrication de matériel
médical — Exigences et méthodes d’essai
Reference number
ISO 9626:2016(E)
ISO 2016
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SIST EN ISO 9626:2016
ISO 9626:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 9626:2016
ISO 9626:2016(E)
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 Surface finish and visual appearance .................................................................................................................................. 2

5.3 Cleanliness .................................................................................................................................................................................................. 2

5.4 Limits for acidity and alkalinity................................................................................................................................................ 2

5.5 Size designation ..................................................................................................................................................................................... 2

5.6 Dimensions ................................................................................................................................................................................................. 2

5.7 Sample size ................................................................................................................................................................................................. 5

5.8 Stiffness ......................................................................................................................................................................................................... 5

5.9 Resistance to breakage ..................................................................................................................................................................... 7

5.10 Resistance to corrosion ................................................................................................................................................................... 7

Annex A (normative) Methods for preparation of extracts........................................................................................................... 8

Annex B (normative) Test method for stiffness of tubing............................................................................................................... 9

Annex C (normative) Test method for resistance of tubing to breakage .....................................................................11

Annex D (normative) Test method for resistance to corrosion .............................................................................................13

Annex E (informative) Rationale with respect to test method for stiffness of tubing ....................................14

Bibliography .............................................................................................................................................................................................................................23

© ISO 2016 – All rights reserved iii
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SIST EN ISO 9626:2016
ISO 9626:2016(E)
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).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO’s adherence to the WTO principles in the Technical

Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information.

The committee responsible for this document is ISO/TC 84, Devices for administration of medicinal

products and catheters.

This second edition cancels and replaces the first edition (ISO 9626:1991), which has been technically

revised. It also incorporates the Amendment ISO 9626:1991/Amd 1:2001.

The main changes to the previous edition of ISO 9626 introduced by this revision are the following:

a) addition of specifications for stainless steel needle tubing for metric sizes 0,18 mm, 0,2 mm

0,23 mm and 0,25 mm and to reflect the introduction of thinner tubing to allow greater comfort

when injecting, particularly for infants and in paediatric use;

b) addition of wall thickness designations beyond regular-walled and thin-walled tubing;

c) addition of minimum inner diameters for additional items where possible;
d) revision of the means of specifying the steels to be used;
e) revision of the table of tubing dimensions and stiffness parameters.

Annex A, Annex B, Annex C, Annex D and Annex E form an integral part of this International Standard.

iv © ISO 2016 – All rights reserved
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SIST EN ISO 9626:2016
ISO 9626:2016(E)
Introduction

Guidance on transition periods for implementing the requirements of this International Standard is

given in ISO/TR 19244.
© ISO 2016 – All rights reserved v
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SIST EN ISO 9626:2016
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SIST EN ISO 9626:2016
INTERNATIONAL STANDARD ISO 9626:2016(E)
Stainless steel needle tubing for the manufacture of
medical devices — Requirements and test methods
1 Scope

This International Standard 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 International Standard 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 International Standard 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 International Standard. However, manufacturers and purchasers

of flexible tubing are encouraged to adopt the dimensional specifications given in this International

Standard.
2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. 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.
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

Note 1 to entry: 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

Note 1 to entry: It is expressed as RW=Regular Wall, TW=Thin Wall, ETW= Extra Thin Wall, and UTW=Ultra Thin

Wall as designated in Table 1.
© ISO 2016 – All rights reserved 1
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SIST EN ISO 9626:2016
ISO 9626:2016(E)
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 International Standard. 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 Surface finish and visual appearance

When examined by normal or corrected vision, 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.
5.3 Cleanliness

When examined by normal or corrected vision, 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.

5.4 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.

5.5 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), and by wall thickness.

EXAMPLE 0,25 mm (31G) ETW.
5.6 Dimensions
The dimensions of tubing shall be as given in Table 1.
2 © ISO 2016 – All rights reserved
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SIST EN ISO 9626:2016
ISO 9626:2016(E)
Table 1 — Dimensions of tubing
Designated metric
OD OD ID
MIN MAX MIN
size
Gauge Wall
mm mm mm
RW 0,064
0,18 34 0,178 0,191 TW 0,091
ETW 0,105
RW 0,089
0,20 33 0,203 0,216 TW 0,105
ETW 0,125
RW 0,089
TW 0,105
0,23 32 0,229 0,241
ETW 0,125
UTW 0,146
RW 0,114
TW 0,125
0,25 31 0,254 0,267
ETW 0,146
UTW 0,176
RW 0,133
TW 0,165
0,30 30 0,298 0,320
ETW 0,190
UTW 0,240
RW 0,133
TW 0,190
0,33 29 0,324 0,351
ETW 0,240
UTW 0,265
RW 0,133
0,36 28 0,349 0,370
TW 0,190
RW 0,184
0,40 27 0,400 0,420
TW 0,241
RW 0,232
0,45 26 0,440 0,470
TW 0,292
RW 0,232
0,50 25 0,500 0,530
TW 0,292
RW 0,280
0,55 24 0,550 0,580
TW 0,343
RW 0,317
0,60 23 0,600 0,673 TW 0,370
ETW 0,460

NOTE 1 RW = Regular Wall; TW = Thin Wall; ETW = Extra Thin Wall; UTW = Ultra Thin Wall.

NOTE 2 Needle sizes below 0,25 mm, consideration can be made to the measurement uncertainty of

existing measurement equipment.
NOTE 3 This International Standard does not specify maximum inner diameter.
NOTE 4 OD = outer diameter; ID = inner diameter.
© ISO 2016 – All rights reserved 3
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SIST EN ISO 9626:2016
ISO 9626:2016(E)
Table 1 (continued)
Designated metric
OD OD ID
MIN MAX MIN
size
Gauge Wall
mm mm mm
RW 0,390
0,70 22 0,698 0,730 TW 0,440
ETW 0,522
RW 0,490
TW 0,547
0,80 21 0,800 0,830
ETW 0,610
UTW 0,645
RW 0,560
TW 0,635
0,90 20 0,860 0,920
ETW 0,687
UTW 0,713
RW 0,648
TW 0,750
1,10 19 1,030 1,100
ETW 0,850
UTW 0,891
RW 0,790
1,20 18 1,200 1,300 TW 0,910
ETW 1,041
RW 0,950
TW 1,156
1,40 17 1,400 1,510
ETW 1,244
UTW 1,276
RW 1,100
1,60 16 1,600 1,690 TW 1,283
ETW 1,390
RW 1,300
1,80 15 1,750 1,900 TW 1,460
ETW 1,560
RW 1,500
2,10 14 1,950 2,150 TW 1,600
ETW 1,727
RW 1,700
2,40 13 2,300 2,500
TW 1,956
RW 1,950
2,70 12 2,650 2,850
TW 2,235

NOTE 1 RW = Regular Wall; TW = Thin Wall; ETW = Extra Thin Wall; UTW = Ultra Thin Wall.

NOTE 2 Needle sizes below 0,25 mm, consideration can be made to the measurement uncertainty of

existing measurement equipment.
NOTE 3 This International Standard does not specify maximum inner diameter.
NOTE 4 OD = outer diameter; ID = inner diameter.
4 © ISO 2016 – All rights reserved
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SIST EN ISO 9626:2016
ISO 9626:2016(E)
Table 1 (continued)
Designated metric
OD OD ID
MIN MAX MIN
size
Gauge Wall
mm mm mm
RW 2,200
3,00 11 2,950 3,150
TW 2,464
RW 2,500
3,40 10 3,300 3,500
TW 2,819

NOTE 1 RW = Regular Wall; TW = Thin Wall; ETW = Extra Thin Wall; UTW = Ultra Thin Wall.

NOTE 2 Needle sizes below 0,25 mm, consideration can be made to the measurement uncertainty of

existing measurement equipment.
NOTE 3 This International Standard does not specify maximum inner diameter.
NOTE 4 OD = outer diameter; ID = inner diameter.
5.7 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.

5.8 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 International Standard, 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.
© ISO 2016 – All rights reserved 5
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SIST EN ISO 9626:2016
ISO 9626:2016(E)
6 © ISO 2016 – All rights reserved
Table 2 — Conditions for stiffness test

Regular-walled tubing Thin-walled tubing Extra-thin walled tubing Ultra-thin walled tubing

Designated Span Bending Maximum Span Bending Maximum Span Bending Maximum Span Bending Maximum

metric size mm ± 0,1 force deflection mm ± 0,1 force deflection mm ± 0,1 force deflection mm ± 0,1 force deflection

N ± 0,1 mm N ± 0,1 mm N ± 0,1 mm N ± 0,1 mm
a a a a a a a a a a a a
0,18
a a a a a a
0,2 5,0 0,6 0,25 5,0 0,6 0,27
0,23 5,0 0,9 0,20 5,0 0,9 0,20 5,0 0,9 0,22 5,0 0,9 0,25
0,25 5,0 1,1 0,17 5,0 1,1 0,18 5,0 1,1 0,21 5,0 1,1 0,24
0,3 5,0 1,3 0,11 5,0 1,3 0,11 5,0 1,3 0,16 5,0 1,3 0,20
0,33 5,0 1,6 0,09 5,0 1,6 0,12 5,0 1,6 0,17 5,0 1,6 0,19
a a a a a a
0,36 5,0 3,6 0,14 5,0 3,6 0,14
a a a a a a
0,4 9,5 2,7 0,52 7,5 3,4 0,34
a a a a a a
0,45 10,0 3,1 0,45 10,0 3,1 0,51
a a a a a a
0,5 10,0 5,1 0,37 10,0 5,1 0,40
a a a a a a
0,55 10,0 6,4 0,34 10,0 6,4 0,36
a a a
0,6 12,5 4,8 0,33 12,5 4,8 0,43 12,5 4,8 0,51
a a a
0,7 15,0 6,7 0,42 15,0 6,7 0,52 15,0 6,7 0,60
a a a
0,8 15,0 9,6 0,38 15,0 9,6 0,45 15,0 9,6 0,51
a a a
0,9 17,5 9,0 0,48 17,5 9,0 0,56 17,5 9,0 0,60
a a a
1,1 25,0 9,7 0,71 25,0 9,7 0,97 25,0 9,7 1,08
a a a a a a
1,2 25,0 12,2 0,51 25,0 12,2 0,81
a a a
1,4 25,0 16,6 0,46 25,0 16,6 0,68 25,0 16,6 0,82
a a a
1,6 25,0 22,0 0,25 25,0 22,0 0,30 25,0 22,0 0,34
a a a a a a
1,8 25,0 25,0 0,35 25,0 25,0 0,45
a a a a a a
2,1 30,0 40,0 0,40 30,0 40,0 0,50
a a a a a a
2,4 40,0 40,0 0,38 40,0 40,0 0,65
a a a a a a
2,7 40,0 50,0 0,31 40,0 50,0 0,45
a a a a a a
3 50,0 50,0 0,41 50,0 50,0 0,55
a a a a a a
3,4 50,0 60,0 0,32 50,0 60,0 0,46

No data are available; therefore, this International Standard does not specify stiffness properties for these sizes of tubing.

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SIST EN ISO 9626:2016
ISO 9626:2016(E)
5.9 Resistance to breakage

When tested in accordance with Annex C, the tubing shall not show visible breakage when examined by

normal or corrected vision.

NOTE Consideration can be given to the final product’s intended use to determine if additional tests are

warranted.
5.10 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 2016 – All rights reserved 7
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SIST EN ISO 9626:2016
ISO 9626:2016(E)
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.

8 © ISO 2016 – All rights reserved
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SIST EN ISO 9626:2016
ISO 9626:2016(E)
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
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SIST EN ISO 9626:2016
ISO 9626:2016(E)
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,
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) whether the tubing was of RW, TW, ETW or UTW type;
c) the measured deflection, expressed in millimetres to the nearest 0,01 mm;
d) the date of testing;
e) the type of stainless steel alloy used, chosen according to Clause 4.
10 © ISO 2016 – All rights reserved
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SIST EN ISO 9626:2016
ISO 9626:2016(E)
Annex C
(normative)
Test method for resistance of tubing to breakage
C.1 Principle

One end of the tubing is firmly fixed and a force applied to the tubing at a specified distance from the

point of fixation, so as to bend the tubing through a specified angle, first in one direction and then in the

opposite direction, for a specified number of cycles.
C.2 Apparatus
C.2.1 Support and device for fixing the tubing.

C.2.2 Equipment, capable of applying a force to the tubing sufficient to bend it through an angle of

up to 25°.
C.3 Procedure
C.3.1 Rigidly fix one end of the tubing in the support (C.2.1).

C.3.2 Apply (C.2.2), at the distance given in Table C.1, a force of sufficient magnitude to cause the tubing

to bend in one plane through an angle of (25 ± 1)° for regular-walled tubing, (20 ± 1)° for thin-walled

tubing, or (15 ± 1)° for extra-thin-walled and ultra-thin walled tubing.

C.3.3 Apply the force in the reverse direction so as to cause the tubing to bend through the same angle

in the reverse direction.

C.3.4 Perform 20 complete cycles of reversal of force at a rate of 0,5 Hz and examine the tubing visually

for breakage.
C.4 Test report
The test report shall contain at least the following information:
a) the identity and designated metric size of the tubing;

b) whether the tubing was of regular-walled, thin-walled, extra-thin walled or ultra-thin walled type;

c) whether the tubing shows visible breakage during the test;
d) the date of testing;
e) the type of stainless steel alloy used, chosen according to Clause 4.
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SIST EN ISO 9626:2016
ISO 9626:2016(E)
Table C.1 — Conditions for resistance to breakage test
Distance between rigid support
and point of application of bending
Designated metric size force
±0,1
0,18 6
0,2 6
0,23 6
0,25 8
0,3 8
0,33 8
0,36 8
0,4 8
0,45 10
0,5 10
...

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