DIN EN ISO 9626-2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626 2016) German version EN ISO 9626 2016《供制造医疗器械用的不.pdf

1、December 2016 English price group 16No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.25!%K“2599140www.din.deD

2、IN EN ISO 9626Stainless steel needle tubing for the manufacture of medical devices Requirements and test methods (ISO 9626:2016);English version EN ISO 9626:2016,English translation of DIN EN ISO 9626:2016-12Kanlenrohre aus nichtrostendem Stahl zur Herstellung von Medizinprodukten Anforderungen und

3、Prfverfahren (ISO 9626:2016);Englische Fassung EN ISO 9626:2016,Englische bersetzung von DIN EN ISO 9626:2016-12Tubes daiguilles en acier inoxydable pour la fabrication de matriel mdical Exigences et mthodes dessai (ISO 9626:2016);Version anglaise EN ISO 9626:2016,Traduction anglaise de DIN EN ISO 9

4、626:2016-12SupersedesDIN EN ISO 9626:200203 andDIN EN ISO 9626Corrigendum 1:201301www.beuth.deDocument comprises 32 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.01.17 DIN EN ISO 9626:2016-12 2 A comma is used as the decimal

5、marker. National foreword This document (EN ISO 9626:2016) has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal products and catheters” (Secretariat: DS, Denmark) in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DI

6、N, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-02-01 AA Injektionssysteme. The DIN Standards corresponding to the International Standards referred to in this document are as follows: IS

7、O 3696 DIN ISO 3696 ISO 14971 DIN EN ISO 14971 ISO 10993-1 DIN EN ISO 10993-1 Amendments This standard differs from DIN EN ISO 9626:2002-03 and DIN EN ISO 9626 Corrigendum 1:2013-01 as follows: a) specifications have been added for stainless steel needle tubing for metric sizes 0,18 mm, 0,2 mm, 0,23

8、 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) wall thickness designations beyond regular-walled and thin-walled tubing have been added; c) minimum inner diameters for additional items have

9、 been added where possible; d) the means of specifying the steels to be used has been revised; e) the table of tubing dimensions and stiffness parameters has been revised. Previous editions DIN EN ISO 9626: 1995-06, 2002-03 DIN EN ISO 9626 Corrigendum 1: 2013-01 DIN EN ISO 9626:2016-12 3 National An

10、nex NA (informative) Bibliography DIN ISO 3696, Water for analytical laboratory use Specification and test methods DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a

11、risk management system DIN EN ISO 9626:2016-12 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9626 August 2016 ICS 11.040.25 Supersedes EN ISO 9626:1995English Version Stainless steel needle tubing for the manufacture of medical devices - Requirements and

12、 test methods (ISO 9626:2016) Tubes daiguilles en acier inoxydable pour la fabrication de matriel mdical - Exigences et mthodes dessai (ISO 9626:2016) Kanlenrohre aus nichtrostendem Stahl zur Herstellung von Medizinprodukten - Anforderungen und Prfverfahren (ISO 9626:2016) This European Standard was

13、 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 natio

14、nal 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 langua

15、ge 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,

16、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 COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-

17、CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9626:2016 EEuropean foreword .3Introduction 51 Scope . 62 Normative references 63 Terms and definitions . 64 Mate

18、rials . 75 Requirements 75.1 General . 75.2 Surface finish and visual appearance 75.3 Cleanliness 75.4 Limits for acidity and alkalinity 75.5 Size designation . 75.6 Dimensions . 75.7 Sample size 105.8 Stiffness 105.9 Resistance to breakage 125.10 Resistance to corrosion 12Annex A (normative) Method

19、s for preparation of extracts 13Annex B (normative) Test method for stiffness of tubing 14Annex C (normative) Test method for resistance of tubing to breakage .16Annex D (normative) Test method for resistance to corrosion .18Annex E (informative) Rationale with respect to test method for stiffness o

20、f tubing 19Bibliography .28Contents Page2DIN EN ISO 9626:2016-12 EN ISO 9626:2016 (E)Foreword .4European 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 Commi

21、ttee 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 wit

22、hdrawn 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. Acco

23、rding 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

24、, 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 w

25、ithout any modification. 3DIN EN ISO 9626:2016-12 EN ISO 9626:2016 (E)ForewordISO (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 technic

26、al 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 wi

27、th 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

28、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 righ

29、ts. 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

30、 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 ISOs adherence to the WTO principles in the Technical Barriers to

31、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 revi

32、sed. 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

33、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

34、 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.4DIN EN ISO 9626:2016-12 EN ISO 9626:2016 (E)IntroductionGuidance on transition period

35、s for implementing the requirements of this International Standard is given in ISO/TR 19244.5DIN EN ISO 9626:2016-12 EN ISO 9626:2016 (E)1 ScopeThis International Standard applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devic

36、es 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.T

37、his 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

38、 International Standard. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in this International Standard.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indisp

39、ensable 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 methodsISO 15510, Stainless steels Chemical

40、 composition3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1designated metric sizeouter diameter designation of the tubing as defined in Table 1Note 1 to entry: It is expressed in millimetres.3.2gaugelegacy size designationNote 1 to entry: A par

41、ticular gauge size corresponds to a designated metric size defining limits for outer diameters.3.3wall thicknessmaterial thickness between the inner and outer diameter of the tubeNote 1 to entry: It is expressed as RW=Regular Wall, TW=Thin Wall, ETW= Extra Thin Wall, and UTW=Ultra Thin Wall as desig

42、nated in Table 1.6DIN EN ISO 9626:2016-12 EN ISO 9626:2016 (E)4 MaterialsTubing 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 m

43、ade 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 Requirements5.1 GeneralFor the selection of tubing for a specific application and intended use, a

44、risk based approach shall be applied.5.2 Surface finish and visual appearanceWhen 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

45、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 CleanlinessWhen examined by normal or corrected vision, the surfaces of the tubing shall

46、 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 alkalinityWhen determined wit

47、h 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 designationTubing size shall be designated by the nominal outer diameter, expressed in millimetres (i.e. the

48、 designated metric size), corresponding gauge size (e.g. G31 or 31G), and by wall thickness.EXAMPLE 0,25 mm (31G) ETW.5.6 DimensionsThe dimensions of tubing shall be as given in Table 1.7DIN EN ISO 9626:2016-12 EN ISO 9626:2016 (E)Table 1 Dimensions of tubingDesignated metric sizemmGaugeODMINmmODMAX

49、mmWallIDMINmm0,18 34 0,178 0,191RW 0,064TW 0,091ETW 0,1050,20 33 0,203 0,216RW 0,089TW 0,105ETW 0,1250,23 32 0,229 0,241RW 0,089TW 0,105ETW 0,125UTW 0,1460,25 31 0,254 0,267RW 0,114TW 0,125ETW 0,146UTW 0,1760,30 30 0,298 0,320RW 0,133TW 0,165ETW 0,190UTW 0,2400,33 29 0,324 0,351RW 0,133TW 0,190ETW 0,240UTW 0,2650,36 28 0,349 0,370RW 0,133TW 0,1900,40 27 0,400 0,420RW 0,184TW 0,2410,45 26 0,440 0,470RW 0,232TW 0,2920,50 25 0,500 0,530RW 0,232TW 0,2920,55 24 0,550 0