EN ISO 9626:1995
(Main)Stainless steel needle tubing for the manufacture of medical devices (ISO 9626:1991)
Stainless steel needle tubing for the manufacture of medical devices (ISO 9626:1991)
Specifies the dimensions, surface and mechanical properties of normal- and thin-walled tubing of designated metric sizes 3,4 mm to 0,3 mm, and of extra-thin-walled tubing of designated metric sizes 2,1 mm to 0,6 mm.
Kanülenrohre aus nichtrostendem Stahl zur Herstellung von Medizinprodukten (ISO 9626:1991)
Diese Internationale Norm legt Maße, Oberflächenbeschaffenheit und mechanischeEigenschaften von Kanülenrohren mit normaler Rohrwand und dünner Rohrwand in den Nenngrößen im metrischen System von 3,4 mm bis 0,3 mm und Kanülenrohren mit extra dünner Rohrwand in den Nenngrößen im metrischen System von 2,1 mm bis 0,6 mm fest.
Tubes d'aiguilles en acier inoxydable pour la fabrication de matériel médical (ISO 9626:1991)
La présente Norme internationale prescrit les dimensions, la surface et les propriétés mécaniques des tubes normaux et à paroi mince de dimensions théoriques 3,4 mm à 0,3 mm et des tubes à paroi très mince de dimensions théoriques de 2,1 mm à 0,6 mm. En l'absence de données, la présente Norme internationale ne prescrit pas de propriétés de rigidité pour les tubes à paroi très mince de dimensions théoriques 0,8 mm, 0,9 mm, 1,2 mm, 1,4 mm, 1,8 mm et 2,1 mm. La présente Norme internationale est applicable aux tubes d'aiguilles rigides en acier inoxydable pouvant être utilisés dans la fabrication des aiguilles hypodermiques et d'autres matériels médicaux principalement à usage humain. 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 la présente Norme internationale. Toutefois, les fabricants et acheteurs de tubes flexibles sont invités à adopter les spécifications dimensionnelles indiquées dans la présente Norme internationale.
Igle iz nerjavnega jekla za izdelavo medicinskih pripomočkov (ISO 9626:1991)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2000
,JOHL]QHUMDYQHJDMHNOD]DL]GHODYRPHGLFLQVNLKSULSRPRþNRY ,62
Stainless steel needle tubing for the manufacture of medical devices (ISO 9626:1991)
Kanülenrohre aus nichtrostendem Stahl zur Herstellung von Medizinprodukten (ISO
9626:1991)
Tubes d'aiguilles en acier inoxydable pour la fabrication de matériel médical (ISO
9626:1991)
Ta slovenski standard je istoveten z: EN ISO 9626:1995
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.
INTERNATIONAL
STANDARD
First edition
199 1-09-0‘1
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m-
Stainless steel needle tubing for manufacture of
medical devices
Tubes d’aiquilles en acier inoxydable pour la fabrication de mat&-iel
medical c
Reference number
IS0 9626: 199 1 (E)
IS0 9626:1991 (E)
Contents
Page
1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2 Normative references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
3 Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
4 Surface finish
5 Cleanliness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
6 Limits for acidity and alkalinity . . . . . . . . . .I. 1
7 Size designation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
8 Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
9 Stiffness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
10 Resistance to breakage . . . .I. 3
11 Resistance to corrosion . . . . . . . . . . . . . . .I. 3
Annexes
A Determination of acidity or alkalinity of tubing . 5
Method of preparation of extracts . 6
B
Test method for stiffness of tubing 7
C .
D Test method for resistance of tubing to breakage
. . . . . . . . . . . . . . . . . 8
Test method for resistance to corrosion
E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
0 IS0 1991
All rights reserved. No part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without
permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-1211 Genkve 20 l Switzerland
Printed in Switzerland
ii
IS0 9626:1991(E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide
federation of national standards bodies (IS0 member bodies). The work
of preparing International Standards is normally carried out through IS0
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, govern-
mental and non-governmental, in liaison with ISO, also take part in the
work. IS0 collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an Inter-
national Standard requires approval by at least 75 % of the member
bodies casting a vote.
International Standard IS0 9626 was prepared by Technical Committee
ISO/TC 84, Syringes for medical use and needles for injections, Sub-
Committee SC I, Syringes and needles for single use.
Annexes A, B, C, D and E form an integral part of this International
Standard.
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INTERNATIONAL STANDARD IS0 9626:1991 (E)
Stainless steel needle tubing for manufacture of medical
devices
IS0 3696:1987, Water for analytical laboratory use -
1 Scope
Specification and test methods.
This International Standard specifies the dimen-
sions, surface and mechanical properties of normal-
3 Materials
and thin-walled tubing of designated metric sizes
3,4 mm to 0,3 mm, and of extra-thin-walled tubing
of designated metric sizes 2,1 mm to 0,6 mm. Tubing shall be made from austenitic stainless steel
of types 10, II, 16, 20, 21 or 23 in accordance with
Because no data are available, this International
IS0 683-l 3.
Standard does not specify stiffness properties for
extra-thin-walled tubing of designated metric sizes
0,8 mm; 0,9 mm; I,2 mm; I,4 mm; I,8 mm and
4 Surface finish
2,l mm.
When examined by normal or corrected vision, the
This International Standard applies to rigid stainless
outside surface of the tubing shall be smooth and
steel needle tubing suitable for use in the manufac-
free from defects.
ture of hypodermic needles and other medical de-
vices primarily for human use.
It does not apply to flexible stainless steel tubing 5 Cleanliness
because the mechanical properties differ from those
specified for rigid tubing in this International Stan- When examined by normal or corrected vision, the
dard. However, manufacturers and purchasers of surfaces of the tubing shall be free from metal soil
flexible tubing are encouraged to adopt the dimen- and processing agents.
sional specifications given in this International
Standard .
6 Limits for acidity and alkalinity
2 Normative references
When tested in accordance with annex A, an extract
of the tubing prepared in accordance with annex B
The following standards contain provisions which,
shall, when corrected for the volume of titrant re-
through reference in this text, constitute provisions
quired for the control fluid, require not more than
of this International Standard. At the time of publi-
0,04 ml of sodium hydroxide solution or not more
cation, the editions indicated were valid. All stan-
than 0,12 ml of hydrochloric acid solution to reach
dards are subject to revision, and parties to
the end-point of the titration.
agreements based on this International Standard
are encouraged to investigate the possibility of ap-
plying the most recent editions of the standards in-
dicated below. Members of IEC and IS0 maintain 7 Size designation
registers of currently valid International Standards.
Tubing shall be designated by the nominal outside
IS0 683-l 3: 1986, Heat-treatable steels, alloy steels diameter expressed in millimetres (i.e. the desig-
and free-cutting steels - Part 13: Wrought stainless nated metric size) and by its category, i.e. normal-
steels. walled, thin-walled, or extra-thin-walled.
IS0 9626:1991 (E)
9 Stiffness
8 Dimensions
When tested in accordance with annex C, the tubing
The dimensions of tubing shall be as given in shall show a deflection not greater than the relevant
value given in table 2.
table 1.
Table 1 - Dimensions of tubing
Dimensions in millimetres
Inside diameter of tubing
Range of outside diameters11
Designated
Normal-walled Thin-walled Extra-thin-wallet
metric size
min. max. min. max. min. max. min.
- -
0,133
093 0,298 0,320 0,164 0,165
-
-
0,351 0,133 0,190
0,33 0,324 0,189
- -
0,349 0,370 0,133 0,190
0,36 0,189
- -
0,184 0,240
074 0,400 0,420 0,241
- -
0,470 0,232 0,291
0,45 0,440 0,292
-
-
0,530 0,232
03 0,500 0,291 0,292
-
-
0,550 0,580 0,280 0,343
0,55 0,342
0,650 0,317 0,380
076 0,600 0,359 0,360 0,379
0,730 0,390 0,459 0,460
07 0,698 0,439 0,440
0,800 0,830 0,490 0,549 0,550
078 0,529 0,530
0,860 0,920 0,560 0,610 0,629 0,630
o,g 0,609
1,030 1,100 0,648 0,750 0,849 0,850
191 0,749
0,790 1,041
12 1,200 1,300 0,910 1,040
0,909
1,510 0,950 1,243 1,244
194 1,400 1,155 1,156
1,600 1,690 1,100 1,389 1,390
143 1,282 1,283
1,900 1,300 1,559 1,560
198 1,750 1,459 1,460
291 1,950 2,150 1,500 1,600 1,726 1,727
1,599
-
-
2,300 2,500 1,700 1,956
Z4 1,955
- -
1,950
297 2,650 2.850 2,234 2,235
2,464 - -
2,463
2,950 3,150 2,200
- -
3,500 2,500
394 3,300 2,818 2,819
1) Needle tubing should have a tolerance of + 0,Ol mm on the actual outside diameter.
-
SIST EN ISO 9626
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