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 180 9626:2016(E) © 180 20161S0 9626:2016(E) A COPYRIGHT PROTECTED DOCUMENT © 150 2016, Published in Switzerland, All rights reserved. Unless otherwise specified, no part ofthis publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, oF posting on the internet or an intranet, without prior \written permission. Permission can be requested from either ISO atthe address below or ISO's member body in the country of the requester: 150 copyright office Ch. de Blandonnet 8 » CP 401 (CH-1214 Vernier, Geneva, Switzerland Tel. +4122 74901 11 Fax +41 227490947 [email protected] wnvrwiso.org cattle o @ 180 2016 Allrights reserved1S0 9626:2016(E) Contents Foreword Introduction. 1 Scope. 2 Normative references. 3 Terms and definitions 4 Materials 5 Requirements 5.1 General 5.2 Surface finish and visual appearance. 5.3 Cleanliness 5.4 Limits for acidity and alkalinity. 5.5 Size designation. 5.6 Dimensions 5.7 Sample size 5.8 Stiffness 5.9 Resistance to breakage. 5.10 Resistance to corrosion Annex A (normative) Methods for preparation of extracts. Annex B (normative) Test method for stiffness of tubing, Annex C (normative) Test method for resistance of tubing to breakage Annex D (normative) Test method for resistance to corrosion Annex E (informative) Rationale with respect to test method for stiffness of tubing Bibliography corte mores ouRbAD ODS adlh Fights reserved Page = © @ VVOUNNNNKRN NH Ree Bran1S0 9626:2016(E) Foreword 1S0 (the International Organization for Standardization) isa 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. 180 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 wwiw.iso.ore/patents). Any trade name used in this document is informal constitute an endorsement. nn given for the convenience of users and does not 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. Italso 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; 1b) addition of wall thickness designations beyond regular-walled and thin-walled tubing; )_ addition of minimum inner diameters for additional items where possible; 4d) revision of the means of specifying the steels to be used; @) 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, caret oni oumeatonte Suendenin @ 180 2016 Allrights reserved1S0 9626:2016(E) Introduction Guidance on transition periods for implementing the requirements of this International Standard is given in ISO/TR 19244, corte more ouRbiDi ODS aclh Hight reserved v‘orate Cesnnonty Saemet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. 10 3696, Water for analytical laboratory use — Specification and test methods 10 15510, Stainless steels — Chemical composition 3. Terms and definitions For the purposes of this document, the following terms and definitions apply. 34 designated metric size outer diameter designation of the tubing as defined in Table 1 Note 1 to entry: Itis 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. 33. wall thickness material thickness between the inner and outer diameter of the tube Note 1 to entry: tis expressed as RW=Regular Wall, TW=Thin Wall, ETW= Extra Thin Wall, and UTW=Ultra Thin Wall as designated in Table 1. ceo rmraor OoRARA PBA aAAl) Fights reserved 11S0 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 10 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 aci ity 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 316), and by wall thickness. EXAMPLE 0,25 mm (31G) ETW. 5.6 Dimensions ‘The dimensions of tubing shall be as given in Table 1. caret been Oumetonte Suendetin @ 180 2016 Allrights reservedTable 1 — Dimensions of tubing 1S0 9626:2016(E) Designated metric op: op: 1D) aed Gauge sn max | wan iN ‘mn mm mm. mm RW 0.064 ose 34 0,178 091 Tw 0,091 TW 0,105 RW 0,089 020 3 0,203 0.216 TW. 0.105 ETW 04125 RW 0,089 023 32 0229 0241 tw 0108) ETW 0425 TW 0146 RW. oat TW 0.125 02s 31 0254 0.267 ETW 0.146 uTW 0.176 RW 0133 TW. 0,165 030 30 0.298 0,320 FTW 0,190 TW 0240 RW 0133 Tw 0,190 033 29 0324 0351 ETW 0,240 uTw 0.265 RW x 0.36 28 0349 0370 0188 TW 0,190 RW 084 040 ar 0,400 0420 Tw. 0.241 RW 0232 045 26 0440 0470 Tw 0292 RW 0.232 050 25 0,500 0530 Ww 202 RW 0.280 oss m 0550 0,500 TW 0343 RW 0317 060 23 0.600 0.673 Tw. 0.370 FTW 0460 [NOTE 1 RW= Regular Wall TW= Thin Wall, ETW =Extra Thin Wall UTW= Ulera Thin Wal, INOTE2 Neeile sizes below 0,25 mm, consideration can be made to the measurement uncertainty of existing measurement equipment. INOTE3 This International Standard doesnot specify maximum inner diameter. NOTE 4 0D = outer diameter; ID = inner diameter. corel wmsiora ORAM PBA SaAlh Fights reserved1S0 9626:2016(E) Table 1 (continued) Designated metric Gauge | OMY ODmax Walt IDuiw RW 0.390 0,70 2 0,698 0,730 TW 0440 eTW, 0,522 RW 0.490 TW 0547 0.80 a 0,800 0,830 rw jo uTw 0,645 RW 0.560 0.90 20 0,860 0920 iw 8.655 ETW. 0,687 uTw O73 RW 0,648 TW 0.750 110 19 1,030 1,100 ETW. 0,850 uTW 0.891 RW 0,790 1.20 18 1,200 1,300 TW 0910 ETW 1,041 RW 0,950 TW 1,156 1.40 ” 1.400 1.510 aw Tae 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 1,500 210 4 1950 2,150 TW 1,600 eTW, 1727 RW 1,700 240 13 2,300 2,500 TW 1386 RW 1,950 2,70 2 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. INOTE 3 This International Standard does not specify maximum inner diameter. [NOTE 4 OD = outer diameter: ID = inner diameter corto creneny Sac @ 180 2016 Allrights reserved1S0 9626:2016(E) Table 1 (continued) Designated metric ol 0: 0D) it stee Gauge In MAK | Wan IN 3,00 1 2,950 3,150 Rw 2200 TW 2.464 RW 2,500 340 10 3:300 3500 TW 2,819 INOTET RW = Regular Wall TW INOTE2 Needle sizes below 0,25 mm, consideration can be made to the measurement uncertainty of| existing measurement equipment. fhin Wall, ETW = Extra Thin Wall, UTW = Ultra Thin Wall NOTE 3 This International Standard does not specify maximum inner diameter. NOTE 4 0D = 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. 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AAaAAll Fights reserved 21S0 9626:2016(E) Annex A (normative) Methods for preparation of extracts Al 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. 2.2 Selection of laboratory borosilicate glassware. A3 Procedure A.3.1_ Immerse 3 g of tubing in 250 ml of water (4.2.1) 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 +3) °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. cae Roose OumeatoteSareedetin @ 180 2016 Allrights reserved1S0 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 ofa suitable apparatus is illustrated in Figure B1. B.2.2. Equipment, capable of measuring the deflection of the tubing to the nearest 0,01 mm, — 20° 5mm a , . ' - ! x 60" ' Ly \ \ \U/ 4 — pot yA fo. ! ‘ tri ; 3 : 1 2 asi Key 1 span 2 section ACA 3 seedetail4 4 detail Figure B.1 — Apparatus for stiffness test ceo rmraor OoRARA PBA aAAl) Fights reserved 91S0 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 isas 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 ©) 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. B32 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, B33 Measure and record (3.2.2) 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; ©) the measured deflection, expressed in millimetres to the nearest 0,01 mm; 4) the date of testing; ©) the type of stainless steel alloy used, chosen according to Clause 4. caret Ahn oumetone Senden @ 180 2016 Allrights reserved