BS EN ISO 9626-2016 Stainless steel needle tubing for the manufacture of medical devices Requirements and test methods《供制造医疗器械用的不锈钢针管 要求和试验方法》.pdf

1、BS EN ISO 9626:2016Stainless steel needle tubingfor the manufacture of medicaldevices Requirements andtest methods (ISO 9626:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 9626:2016 BRITISH STANDARDNational forewordThis British Standard is the UK impl

2、ementation of EN ISO 9626:2016.It supersedes BS EN ISO 9626:1995 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/84, Catheters and syringes.A list of organizations represented on this committee can beobtained on request to its secretary.This publicat

3、ion does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 85626 6ICS 11.040.25Compliance with a British Standard cannot confer immunity from

4、legal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 September 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9626 August 2016 ICS 11.040.

5、25 Supersedes EN ISO 9626:1995English Version Stainless steel needle tubing for the manufacture of medical devices - Requirements and 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

6、nichtrostendem Stahl zur Herstellung von Medizinprodukten - Anforderungen und Prfverfahren (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 Sta

7、ndard 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 (Engli

8、sh, 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, B

9、ulgaria, 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,

10、 Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR 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 worldwide for CEN national Membe

11、rs. Ref. No. EN ISO 9626:2016 EBS EN ISO 9626:2016EN ISO 9626:2016 (E) 3 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-ac

12、tive 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

13、 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-CENELE

14、C 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, Icel

15、and, 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

16、. BS EN ISO 9626:2016ISO 9626:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Materials . 25 Requirements 25.1 General . 25.2 Surface finish and visual appearance 25.3 Cleanliness 25.4 Limits for acidity and alkalinity 25.5 Size designation . 25.6 Dime

17、nsions . 25.7 Sample size . 55.8 Stiffness . 55.9 Resistance to breakage . 75.10 Resistance to corrosion . 7Annex A (normative) Methods for preparation of extracts. 8Annex B (normative) Test method for stiffness of tubing. 9Annex C (normative) Test method for resistance of tubing to breakage .11Anne

18、x D (normative) Test method for resistance to corrosion .13Annex E (informative) Rationale with respect to test method for stiffness of tubing 14Bibliography .23 ISO 2016 All rights reserved iiiContents PageBS EN ISO 9626:2016ISO 9626:2016(E)ForewordISO (the International Organization for Standardiz

19、ation) 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

20、 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

21、 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 th

22、e 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 dur

23、ing 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 mea

24、ning 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 Trade (TBT) see the following URL: Foreword - Supplementary information.The committee responsible for this document is ISO/TC 84

25、, 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

26、 by this revision are the following:a) addition of specifications for stainless steel needle tubing for metric sizes 0,18 mm, 0,2 mm0,23 mm and 0,25 mm and to reflect the introduction of thinner tubing to allow greater comfortwhen injecting, particularly for infants and in paediatric use;b) addition

27、 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

28、, Annex C, Annex D and Annex E form an integral part of this International Standard.iv ISO 2016 All rights reservedBS EN ISO 9626:2016ISO 9626:2016(E)IntroductionGuidance on transition periods for implementing the requirements of this International Standard is given in ISO/TR 19244. ISO 2016 All rig

29、hts reserved vBS EN ISO 9626:2016BS EN ISO 9626:2016Stainless steel needle tubing for the manufacture of medical devices Requirements and test methods1 ScopeThis International Standard applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other

30、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

31、-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 t

32、ubing 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 referencesThe following documents, in whole or in part, are normatively referenced in this document a

33、nd 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 methodsISO 15510, Stainless st

34、eels Chemical 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

35、 entry: A particular 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

36、Wall as designated in Table 1.INTERNATIONAL STANDARD ISO 9626:2016(E) ISO 2016 All rights reserved 1BS EN ISO 9626:2016ISO 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 Internat

37、ional 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 Requirements5.1 GeneralFo

38、r the selection of tubing for a specific application and intended use, a 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

39、 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 CleanlinessWhen

40、 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

41、 for cleanliness.5.4 Limits for acidity and alkalinityWhen 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 designationTubing size shall be des

42、ignated 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 DimensionsThe dimensions of tubing shall be as given in Table 1.2 ISO 2016 All rights reservedBS EN ISO 9

43、626:2016ISO 9626:2016(E)Table 1 Dimensions of tubingDesignated metric sizemmGaugeODMINmmODMAXmmWallIDMINmm0,18 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 0,176

44、0,30 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 0,580RW 0,280TW 0,3430,60 23 0,600 0,673

45、RW 0,317TW 0,370ETW 0,460NOTE 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 in

46、ner diameter.NOTE 4 OD = outer diameter; ID = inner diameter. ISO 2016 All rights reserved 3BS EN ISO 9626:2016ISO 9626:2016(E)Designated metric sizemmGaugeODMINmmODMAXmmWallIDMINmm0,70 22 0,698 0,730RW 0,390TW 0,440ETW 0,5220,80 21 0,800 0,830RW 0,490TW 0,547ETW 0,610UTW 0,6450,90 20 0,860 0,920RW

47、0,560TW 0,635ETW 0,687UTW 0,7131,10 19 1,030 1,100RW 0,648TW 0,750ETW 0,850UTW 0,8911,20 18 1,200 1,300RW 0,790TW 0,910ETW 1,0411,40 17 1,400 1,510RW 0,950TW 1,156ETW 1,244UTW 1,2761,60 16 1,600 1,690RW 1,100TW 1,283ETW 1,3901,80 15 1,750 1,900RW 1,300TW 1,460ETW 1,5602,10 14 1,950 2,150RW 1,500TW 1

48、,600ETW 1,7272,40 13 2,300 2,500RW 1,700TW 1,9562,70 12 2,650 2,850RW 1,950TW 2,235NOTE 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

49、 3 This International Standard does not specify maximum inner diameter.NOTE 4 OD = outer diameter; ID = inner diameter.Table 1 (continued)4 ISO 2016 All rights reservedBS EN ISO 9626:2016ISO 9626:2016(E)Designated metric sizemmGaugeODMINmmODMAXmmWallIDMINmm3,00 11 2,950 3,150RW 2,200TW 2,4643,40 10 3,300 3,500RW 2,500TW 2,819NOTE 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