SIST EN ISO 9626:2016
(Main)Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
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.
Kanülenrohre aus nichtrostendem Stahl zur Herstellung von Medizinprodukten (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
Relations
Standards Content (Sample)
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
2
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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.
3
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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
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
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
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
a
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.
3
Maintain the water at a temperature of (37 + ) °C for (60 ± 2) min. Remove the tubing and ensure that
0
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
© ISO 2016 – All rights reserved 9
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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.
© ISO 2016 – All rights reserved 11
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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
mm
±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
...
SLOVENSKI STANDARD
oSIST prEN ISO 9626:2015
01-april-2015
,JOHL]QHUMDYQHJDMHNOD]DL]GHODYRPHGLFLQVNLKSULSRPRþNRY=DKWHYHLQ
SUHVNXVQHPHWRGH ,62',6
Stainless steel needle tubing for the manufacture of medical devices - Requirements and
test methods (ISO/DIS 9626:2015)
Kanülenrohre aus nichtrostendem Stahl zur Herstellung von Medizinprodukten (ISO/DIS
9626:2015)
Tubes d'aiguilles en acier inoxydable pour la fabrication de matériel médical - Exigences
et méthodes d'essai (ISO/DIS 9626:2015)
Ta slovenski standard je istoveten z: prEN ISO 9626 rev
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 9626:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 9626:2015
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oSIST prEN ISO 9626:2015
DRAFT INTERNATIONAL STANDARD
ISO/DIS 9626
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2015-01-29 2015-04-29
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
ICS: 11.040.25
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 9626:2014(E)
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. ISO 2014
---------------------- Page: 3 ----------------------
oSIST prEN ISO 9626:2015
ISO/DIS 9626:2014(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
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
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Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved
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oSIST prEN ISO 9626:2015
ISO/DIS 9626:2014(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Materials . 1
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 . 6
5.8 Stiffness . 6
5.9 Resistance to breakage . 9
5.10 Resistance to corrosion . 9
Annex A (normative) Methods for preparation of extracts.10
Annex B (normative) Test method for stiffness of tubing.11
Annex C (normative) Test method for resistance of tubing to breakage .13
Annex D (normative) Test method for resistance to corrosion .15
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 94/42/EEC .16
© ISO 2014 – All rights reserved iii
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oSIST prEN ISO 9626:2015
ISO/DIS 9626:2014(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
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.
ISO 9626 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and catheters.
This second edition cancels and replaces the first edition, which has been technically revised.
Annexes A, B, C, and D form an integral part of this International Standard.
iv © ISO 2014 – All rights reserved
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oSIST prEN ISO 9626:2015
ISO/DIS 9626:2014(E)
Introduction
The purposes of this International Standard are to:
a) add 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) add wall thickness designations beyond regular- and thin-walled tubing,
c) Add minimum inside diameters for additional items where possible,
d) revise the means of specifying the steels to be used.
Guidance on transition periods for implementing the requirements of this standard is given in
ISO/TR 19244 ‘Guidance on transition periods for standards developed by ISO/TC 84 - Devices for
administration of medicinal products and catheters’.
© ISO 2014 – All rights reserved v
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oSIST prEN ISO 9626:2015
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oSIST prEN ISO 9626:2015
DRAFT INTERNATIONAL STANDARD ISO/DIS 9626:2014(E)
Stainless steel needle tubing for the manufacture of
medical devices — Requirements and test methods
1 Scope
ISO 9626 provides requirements and test methods for the tube 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 (G10) to 0,18 mm (G34).
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.
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 referenced documents are indispensable for the application 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 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 11608-1:2012, Needle-based injection systems for medical use — Requirements and test methods —
Part 1: Needle-based injection systems
1)
ISO 15510, Stainless steels — Chemical composition
ISO 2958, Road vehicles — Exterior protection for passenger cars
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply:
3.1
gauge
method of a standard dimension
Note 1 to entry: Hypodermic needles are available in a wide variety of outer diameters described by gauge
numbers. Smaller gauge numbers indicate larger outer diameters. Inner diameter depends on both gauge and
wall thickness.
4 Materials
Tubing shall be made by stainless steels listed in ISO 15510. The chosen materials shall be in accordance
with ISO 9626 requirements and in accordance with biocompatibility requirements of ISO 10993-1.
Selection of specific stainless steel material shall be made in consideration with the intended use e.g.
long-term contact with drugs.
1) Under revision
© ISO 2014 – All rights reserved 1
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oSIST prEN ISO 9626:2015
ISO/DIS 9626:2014(E)
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 cleanliness.
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 unit of pH of that of the control fluid.
5.5 Size designation
Tubing shall be designated by the nominal outside diameter expressed in millimetres (i.e. the designated
metric size) and by wall thickness.
EXAMPLE 0,25 mm (G31) ETW
5.6 Dimensions
The dimensions of tubing shall be as given in Tables 1 to 3.
2
...
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