INTERNATIONAL
`STANDARD
`
`ISO
`9626
`
`First edition
`1991-09-01
`AMENDMENT 1
`2001-06-01
`
`~
`
`+
`,::;,
`~
`
`Stainless steel needle tubing for the
`manufacture of medical devices -
`
`AMENDMENT 1
`
`Tubes d'aiguilles en acier inoxydable pour la fabrication de materiel
`medical-
`AMENDEMENT 1
`
`-
`-
`-
`
`~
`
`~IS01
`
`~~~
`
`-
`
`-
`-
`
`Reference number
`ISO 9626:1991/Amd.1 :2001 (E)
`
`© ISO 2001
`
`Regeneron Exhibit 1043.001
`
`

`

`ISO 9626:1991/Amd.1 :2001(E)
`
`PDF disclaimer
`
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`~
`
`ISO 2001
`©
`All rights reserved. Unless otherwise specified, 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 either ISO at the address below or ISO's member body
`in the country of the requester.
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`Case postale 56 • CH-1211 Geneva 20
`Tel. + 4122749 0111
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`E-mail copyright@iso.ch
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`Printed in Switzerland
`
`© ISO 2001 - All rights reserved
`
`Regeneron Exhibit 1043.002
`
`

`

`ISO 9626:1991/Amd.1 :2001(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 3.
`
`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 Amendment may be the subject of patent
`rights. ISO shall not be held responsible for identifying any or all such patent rights.
`
`Amendment 1 to International Standard ISO 9626:1991 was prepared by Technical Committee ISO/TC 84, Medical
`devices for injections, Subcommittee SC 1, Syringes, needles and intravascular catheters for single use.
`
`© ISO 2001 - All rights reserved
`
`iii
`
`Regeneron Exhibit 1043.003
`
`

`

`ISO 9626:1991/Amd.1 :2001(E)
`
`Introduction
`
`The purposes of this amendment are to:
`
`,::;,
`~
`
`a) add specifications for normal- and thin-walled tubing of metric sizes 0,2 mm, 0,23 mm and 0,25 mm to reflect
`the introduction of thinner tubing to allow greater comfort when injecting, particularly for infants and in
`paediatric use;
`
`b) add minimum inside diameters for thin-walled tubing of metric sizes 0,3 mm to 0,36 mm, as these data are now
`available;
`
`c)
`
`revise the maximum outside diameter of 0,6 mm metric size tubing to reflect current manufacturing practice;
`
`d) delete the maximum inside diameter of all types of tubing, as this value is not needed to discriminate between
`normal-, thin- and extra-thin-walled tubing;
`
`e)
`
`revise the means of specifying the steels to be used, as a result of the withdrawal of ISO 683-13.
`
`For clarity in this amendment, the revised values in the new Tables 2, 3 and 4 are given in boldface type.
`
`iv
`
`© ISO 2001 - All rights reserved
`
`Regeneron Exhibit 1043.004
`
`

`

`ISO 9626:1991/Amd.1 :2001(E)
`
`Stainless steel needle tubing for the manufacture of medical
`devices-
`
`,::;,
`~
`
`AMENDMENT1
`
`Page 1, Scope
`
`Replace the first paragraph by the following:
`
`"This International Standard specifies the dimensions and mechanical properties of normal-walled and thin(cid:173)
`walled stainless steel tubing of designated metric sizes 3,4 mm to 0,2 mm and of extra-thin-walled tubing of
`designated metric sizes 2, 1 mm to 0,6 mm."
`
`Page 1, Normative references
`
`Delete the reference to ISO 683-13. Add the following normative references:
`
`"ISO/TR 15510: 1997, Stainless steels - Chemical composition.
`
`EN 10088-1: 1995, Stainless steels - Part 1: List of stainless steels."
`
`Page 1, clause 3
`
`Replace existing clause 3 with the following:
`
`"3 Materials
`
`Tubing shall be made of austenitic stainless steel of one of the designated types given in Table 1 or any of the
`corresponding designations given in ISO/TR 15510, Table 2."
`
`Add the following new Table 1:
`
`Table 1 - Types of stainless steel for needle tubing
`
`Designation in
`ISO/TR 15510:1997 and
`EN 10088-1:1995
`
`Line number in Tables 1 and 2
`of ISO/TR 15510:1997
`
`Corresponding type in
`ISO 9626:1991 and
`ISO 683-13:1986
`(for information only)
`
`X2CrNi 18-9
`
`X5CrNi 18-9
`
`X6CrNiNb 18-10
`
`X5CrNiMo 17-12-2
`
`X6CrNiMoTi 17-12-2
`
`X6CrNiMoNb 17-12-2
`
`1
`
`6
`
`17
`
`26
`
`28
`
`29
`
`10
`
`11
`
`16
`
`20
`
`21
`
`23
`
`© ISO 2001 - All rights reserved
`
`1
`
`Regeneron Exhibit 1043.005
`
`

`

`ISO 9626:1991/Amd.1 :2001(E)
`
`Page 2, clause 8
`
`In the first sentence, replace "table 1" with "Table 2". Delete existing Table 1 and replace with new Table 2 below.
`Changes are shown in boldface type.
`
`Table 2 - Dimensions of tubing
`
`Dimensions in millimetres
`
`,::;,
`~
`
`Designated
`metric size
`
`Gauge size 1)
`
`Range of outside diameters
`
`Inside diameter of tubing
`
`Normal-
`walled
`
`Thin-walled
`
`Extra-thin-
`walled
`
`0,2
`
`0,23
`
`0,25
`
`0,3
`
`0,33
`
`0,36
`
`0,4
`
`0,45
`
`0,5
`
`0,55
`
`0,6
`
`33
`
`32
`
`31
`
`30
`
`29
`
`28
`
`27
`
`26
`
`25
`
`24
`
`23
`
`min.
`
`0,203
`
`0,229
`
`0,254
`
`0,298
`
`0,324
`
`0,349
`
`0,400
`
`0,440
`
`0,500
`
`0,550
`
`0,600
`
`max.
`
`0,216
`
`0,241
`
`0,267
`
`0,320
`
`0,351
`
`0,370
`
`0,420
`
`0,470
`
`0,530
`
`0,580
`
`0,673
`
`min.
`
`0,089
`
`0,089
`
`0,114
`
`0,133
`
`0,133
`
`0,133
`
`0,184
`
`0,232
`
`0,232
`
`0,280
`
`0,317
`
`0,390
`
`min.
`
`0,105
`
`0,105
`
`0,125
`
`0,165
`
`0,190
`
`0,190
`
`0,241
`
`0,292
`
`0,292
`
`0,343
`
`0,370
`
`0,440
`
`min.
`-
`-
`-
`-
`-
`-
`
`-
`
`-
`
`-
`
`-
`
`0,460
`
`0,522
`
`0,7
`
`0,8
`
`0,9
`
`1, 1
`
`1,2
`
`1,4
`
`1,6
`
`1,8
`
`2, 1
`
`2,4
`
`2,7
`
`3,0
`
`3,4
`
`22
`
`21
`
`20
`
`19
`
`18
`
`17
`
`16
`
`15
`
`14
`
`13
`
`12
`
`11
`
`10
`
`0,698
`
`0,800
`
`0,860
`
`1,030
`
`1,200
`
`1,400
`
`1,600
`
`1,750
`
`1,950
`
`2,300
`
`2,650
`
`2,950
`
`3,300
`
`0,730
`
`0,830
`
`0,920
`
`1,100
`
`1,300
`
`1,510
`
`1,690
`
`1,900
`
`2,150
`
`2,500
`
`2,850
`
`3,150
`
`3,500
`
`0,490
`
`0,560
`
`0,648
`
`0,790
`
`0,950
`
`1,100
`
`1,300
`
`1,500
`
`1,700
`
`1.950
`
`2,200
`
`2,500
`
`0,547
`
`0,635
`
`0,750
`
`0,910
`
`1,156
`
`1,283
`
`1,460
`
`1,600
`
`1,956
`
`2,235
`
`2,464
`
`2,819
`
`0,610
`
`0,687
`
`0,850
`
`1,041
`
`1,244
`
`1,390
`
`1,560
`
`1,727
`
`-
`
`-
`
`-
`
`-
`
`1) For information only.
`
`2
`
`© ISO 2001 - All rights reserved
`
`Regeneron Exhibit 1043.006
`
`

`

`ISO 9626:1991/Amd.1 :2001(E)
`
`Page 2, clause 9
`
`In the first sentence, replace "table 2" with "Table 3".
`
`Page 3, clause 9
`
`Delete existing Table 2 and replace with new Table 3 below. Changes are shown in boldface type.
`
`,::;,
`~
`
`Table 3 - Conditions for stiffness test
`
`Normal-walled tubing
`
`Thin-walled tubing
`
`Extra-thin walled tubing
`
`Designated
`metric
`size
`
`0,2
`
`0,23
`
`0,25
`
`0,3
`
`Span
`
`mm
`± 0,1
`
`5
`
`5
`
`5
`
`5
`
`Bending Maximum
`force
`deflection
`mm
`
`N
`
`± 0,1
`
`1,2
`
`2
`
`2,8
`
`5,5
`
`5,5
`
`0,35
`
`0,35
`
`0,35
`
`0,40
`
`0,32
`
`Span
`
`mm
`± 0,1
`
`5
`
`5
`
`5
`
`5
`
`5
`
`Bending Maximum
`force
`deflection
`mm
`
`N
`
`± 0,1
`
`1,2
`
`2
`
`2,8
`
`5,5
`
`5,5
`
`0,4
`
`0,4
`
`0,4
`
`0,45
`
`0,37
`
`Span
`
`mm
`± 0,1
`-
`-
`-
`
`-
`
`-
`
`Bending Maximum
`force
`deflection
`mm
`
`N
`
`± 0,1
`-
`-
`-
`
`-
`
`-
`
`-
`-
`-
`
`-
`
`-
`
`0,33
`
`0,36
`
`0,4
`
`0,45
`
`0,5
`
`0,55
`
`0,6
`
`5
`
`5
`
`9,5
`
`10
`
`10
`
`10
`
`12,5
`
`5,5
`
`5,5
`
`6
`
`7
`
`10
`
`10
`
`0,25
`
`0,60
`
`0,56
`
`0,38
`
`0,50
`
`0,40
`
`5
`
`7,5
`
`10
`
`10
`
`10
`
`12,5
`
`5,5
`
`5,5
`
`5,5
`
`7
`
`10
`
`10
`
`0,30
`
`0,65
`
`0,61
`
`0,43
`
`0,55
`
`0,45
`
`0,50
`
`-
`
`-
`
`-
`
`-
`
`-
`
`12,5
`
`15
`
`-
`
`-
`
`-
`
`-
`
`-
`
`10
`
`-
`
`-
`
`-
`
`-
`
`-
`
`0,50
`
`0,55
`
`0,7
`
`0,8
`
`0,9
`
`1, 1
`
`1,2
`
`1,4
`
`15
`
`15
`
`17,5
`
`25
`
`25
`
`25
`
`25
`
`10
`
`15
`
`15
`
`10
`
`20
`
`22
`
`22
`
`0,45
`
`0,41
`
`0,48
`
`0,45
`
`0,45
`
`0,45
`
`0,25
`
`15
`
`15
`
`17,5
`
`25
`
`25
`
`25
`
`25
`
`10
`
`15
`
`15
`
`10
`
`20
`
`22
`
`22
`
`0,50
`
`0,65
`
`0,55
`
`0,55
`
`0,55
`
`0,30
`
`1)
`
`1)
`
`25
`
`1)
`
`1)
`
`25
`
`10
`
`1)
`
`1)
`
`10
`
`1)
`
`1)
`
`22
`
`1)
`
`1)
`
`0,65
`
`1)
`
`1)
`
`0,34
`
`1,6
`
`1,8
`
`2, 1
`
`2,4
`
`2,7
`
`3
`
`3,4
`
`25
`
`30
`
`40
`
`40
`
`50
`
`50
`
`25
`
`40
`
`40
`
`50
`
`50
`
`60
`
`0,35
`
`0,40
`
`0,38
`
`0,31
`
`0,41
`
`0,32
`
`25
`
`30
`
`40
`
`40
`
`50
`
`50
`
`25
`
`40
`
`40
`
`50
`
`50
`
`60
`
`0,45
`
`0,50
`
`0,65
`
`0,45
`
`0,55
`
`0,46
`
`1)
`
`1)
`
`-
`
`-
`
`-
`
`-
`
`1)
`
`1)
`
`-
`
`-
`
`-
`
`-
`
`1)
`
`1)
`
`-
`
`-
`
`-
`
`-
`
`1) No data are available and therefore this International Standard does not specify stiffness properties for these sizes of tubing.
`
`© ISO 2001 - All rights reserved
`
`3
`
`Regeneron Exhibit 1043.007
`
`

`

`ISO 9626:1991/Amd.1 :2001(E)
`
`Page 3, clause 10
`
`Add the phrase "and Table 4" to the first sentence so that the text reads:
`
`"When tested in accordance with annex D and Table 4, the tubing shall not break."
`
`Page4
`
`,::;,
`~
`
`Replace existing table 3 with Table 4 below. Changes are shown in boldface type.
`
`Table 4 - Conditions for resistance to breakage test
`
`Designated metric size
`
`Distance between rigid support
`and point of application of
`bending force
`mm
`± 0,1
`
`0,2
`
`0,23
`
`0,25
`
`0,3
`
`0,33
`
`0,36
`
`0,4
`
`0,45
`
`0,5
`
`0,55
`
`0,6
`
`0,7
`
`0,8
`
`0,9
`
`1, 1
`
`1,2
`
`1,4
`
`1,6
`
`1,8
`
`2, 1
`
`2,4
`
`2,7
`
`3
`
`3,4
`
`6
`
`6
`
`8
`
`8
`
`8
`
`8
`
`8
`
`10
`
`10
`
`12,5
`
`15
`
`17,5
`
`20
`
`25
`
`27,5
`
`30
`
`31,5
`
`31,5
`
`31,5
`
`31,5
`
`31,5
`
`31,5
`
`31,5
`
`31,5
`
`4
`
`© ISO 2001 - All rights reserved
`
`Regeneron Exhibit 1043.008
`
`

`

`ISO 9626:1991/Amd.1 :2001(E)
`
`Page 7, annex C, subc/ause C.3. 1 a)
`
`Delete the words "table 2" and replace with "Table 3".
`
`Page 7, annex C, subc/ause C.3.2
`
`Delete the words "table 2" and replace with "Table 3".
`
`,::;,
`~
`
`Page 8, annex D, subc/ause D.3.2
`
`Delete the words "table 3" and replace with "Table 4".
`
`Page 9
`
`After annex E, create a new bibliography as follows:
`
`"Bibliography
`
`[1]
`
`ISO 683-13:1986 (withdrawn), Heat-treatable steels, alloy steels and free-cutting steels - Part 13: Wrought
`stainless steels."
`
`© ISO 2001 - All rights reserved
`
`5
`
`Regeneron Exhibit 1043.009
`
`

`

`ISO 9626:1991/Amd.1 :2001(E)
`
`,::;,
`~
`
`ICS 11.040.20
`Price based on 5 pages
`
`© ISO 2001 - All rights reserved
`
`Regeneron Exhibit 1043.010
`
`