EN ISO 8362-1-2009 en Injection containers and accessories - Part 1 Injection vials made of glass tubing (Incorporates Amendment A1 2015)《注射容器和附件 第1部分 玻璃管制注射管》.pdf

1、BSENISO8362-1:2009ICS11.040.20NOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAWBRITISHSTANDARDInjectioncontainersandaccessoriesPart1:Injectionvialsmadeofglasstubing(ISO8362-1:2009)BS EN ISO 8362-1:2009 +A1:2015BS EN ISO 8362-1:2009+A1:2015ISBN 978 0 580 86382 0Amendments/corrigenda issued

2、 since publicationDate Comments31 January 2016 Implementation of ISO amendment 1:2015 with CEN endorsement A1:2015: Table 1 updatedThis British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 February 2010 The British Standards Institution 2016. Publis

3、hed by BSI Standards Limited 2016National forewordThis British Standard is the UK implementation of EN ISO 8362-1:2009+A1:2015. It supersedes BS EN ISO 8362-1:2009 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.A list of organizations rep

4、resented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.EUROPEAN

5、STANDARD NORME EUROPENNE EUROPISCHE NORMEN ISO 8362-1 December 2009 ICS 11.040.20 Supersedes EN ISO 8362-1:2004English Version Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2009) Rcipients et accessoires pour produits injectables - Partie1: Flacons e

6、n verre tir (ISO 8362-1:2009) Injektionsbehltnisse und Zubehr - Teil 1:Injektionsflaschen aus Rhrenglas (ISO 8362-1:2009) This European Standard was approved by CEN on 21 December 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving

7、 this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official version

8、s (English, 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 Management Centre has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bu

9、lgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDI

10、ZATION COMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members.Ref. No. EN ISO 8362-1:2009: EEN ISO 8362-1:2009+A1December 2015BS EN I

11、SO 8362-1:2009EN ISO 8362-1:2009 (E)3 Foreword This document (EN ISO 8362-1:2009) has been prepared by Technical Committee ISO/TC 76 “Transfusion,infusion and injection equipment formedical and pharmaceutical use“.This European Standard shall be given the status ofa national standard, either by publ

12、ication of an identical text or byendorsement, at the latest by June 2010, and conflictingnational standards shall bewithdrawn atthe latest by June 2010.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

13、be held responsible for identifying any orall such patent rights. This document supersedes EN ISO 8362-1:2004.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Bulgaria, C

14、yprus, CzechRepublic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the UnitedKingdom. Endorsement noticeThe text of ISO 836

15、2-1:2009 has been approved by CEN as a EN ISO 8362-1:2009 without any modification. BS EN ISO 8362-1:2009+A1:2015EN ISO 8362-1:2009+A1:2015 (E)Foreword to amendment A1This document (EN ISO 8362-1:2009/A1:2015) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, a

16、nd blood processing equipment for medical and pharmaceutical use”.This Amendment to the European Standard EN ISO 8362-1:2009 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2016, and conflicting national standards

17、shall be withdrawn at the latest by June 2016.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.According to the CEN-CENELEC Internal Reg

18、ulations, 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, Iceland, Ireland,

19、Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 8362-1:2009/Amd 1:2015 has been approved by CEN as EN ISO 8362-1:2009/A1:2015 without any modif

20、ication.BS EN ISO 8362-1:2009ISO 8362-1:2009(E) ISO 2009 All rights reserved iiiForeword 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

21、ISO technical committees. Each member body interested in a subject for which a technical committee has beenestablished 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

22、closelywith 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 2.The main task of technical committees is to prepare International Standards. Dr

23、aft International Standardsadopted 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 docu

24、ment may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 8362-1 wasprepared byTechnical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This third edition cancels and replaces

25、 the second edition (ISO 8362-1:2003), which has undergone minorrevision by including further types of neck finishes for injection vials model B neck finishwith blow back(European style) and model C neck finishwith blow back (American style). ISO 8362 consists of the following parts, under the gener

26、al title Injection containers and accessories: Part 1: Injection vials made of glass tubing Part 2: Closures for injection vials Part 3: Aluminium caps for injection vials Part 4: Injection vials made of moulded glass Part 5: Freeze drying closures for injection vials Part 6: Caps made of aluminium-

27、plastics combinations for injection vials Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics partBS EN ISO 8362-1:2009+A1:2015ISO 8362-1:2009+A1:2015 (E)BS EN ISO 8362-1:2009ISO 8362-1:2009(E)iv ISO 2009 All rights reservedIntroduction The purpose of this par

28、t of ISO 8362 is to specify the dimensions, capacities, form and requirements of glass vials intended for medical use. Containers made from glass tubing are considered to be suitable for thepackaging and storage of injectable preparations until theyare administered for medicinal purposes. Suchcontai

29、ners may be made from different types of glass which can affect the chemical resistance properties;e.g., thosemade from borosilicate glasswill have a very high level of chemical resistance whereas others made from soda-lime glass will have a lower, but adequate, chemical resistance for the purpose f

30、or whichthey are intended. The chemical resistance of the internal surface of containers made from soda-lime glass can be improved by means of a treatment during production aimed at producing a chemical resistance equal to that of those made from borosilicate glass for single use. This level of chem

31、ical resistance is maintained aslong as the interior surface is not destroyed by chemical attack, in which case it is reduced to that of untreatedsoda-lime glass.Because containers may be made from different types of glass and because it is the chemical behaviour of the internal surface which is imp

32、ortant when they are filled with injectable preparations, it is essential tospecify test procedures by which this performance can be measured. The procedures recommended in thispart of ISO 8362 permit this performance, based on the hydrolytic resistance to be measured and, from the result of measure

33、ment, it is possible to classify containers into their correct category. The procedure alsoallows containers to be tested and to determine, after an intermediate stage, whether the hydrolytic resistanceis produced by the composition of the glass as a material or by a treatment of the internal surfac

34、e. BS EN ISO 8362-1:2009+A1:2015ISO 8362-1:2009+A1:2015 (E)BS EN ISO 8362-1:2009INTERNATIONAL STANDARD ISO 8362-1:2009(E) ISO 2009 All rights reserved 1Injection containers and accessories Part 1: Injection vials made of glass tubing1 Scope This part of ISO 8362 specifies the form, dimensions and ca

35、pacities of glassvials for injectable preparations.It also specifies the material from which such containers shall be made and the performance requirements of those containers.This part of ISO 8362 applies to colourless or amber glass containers made from borosilicate or soda-limeglass, made from gl

36、ass tubing, whether internally surface-treated or not, and intended to be used in thepackaging, storage or transportation of products intended for injection. 2 NormativereferencesThe following referenced documents are indispensable for the application of this document. For datedreferences, only the

37、edition cited applies. For undated references, the latest edition of the referenceddocument (including any amendments) applies.ISO 719, Glass Hydrolytic resistance of glass grains at 98 C Method of test and classificationISO 720, Glass Hydrolytic resistance of glass grains at 121 C Method of test an

38、d classification ISO 1101, Geometrical Product Specifications (GPS) Geometrical tolerancing Tolerances of form,orientation, location and run-out ISO 4802-1, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part1: Determination by titration method and classification ISO 48

39、02-2, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part2: Determination by flame spectrometry and classification3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 4802-1 and ISO 4808-2 apply.4 Dimensions The dimensions of

40、 injection vials made of glass tubing shall meet the requirements of Figure 1 or Figure2 orFigure 3, as appropriate, and Table 1; the overflow capacity and mass shall be as shown in Table 1. BS EN ISO 8362-1:2009+A1:2015ISO 8362-1:2009+A1:2015 (E)BS EN ISO 8362-1:2009ISO 8362-1:2009(E)2 ISO 2009 All

41、 rights reservedDimensions in millimetres aThe opening of the vial should have a constant diameter, over the entire distance, h3, i.e. it should exhibit a cylindricalshape. A slightly conical shape can be accepted if the following requirements are fulfilled: the truncated cone has the height h3; the

42、 larger diameter is located at the flange or as agreed upon; the larger diameter does not exceed the smaller one by more than 0,3 mm. bThe perpendicularity tolerance a (as defined in ISO 1101) is a limit for the deviation of the plumb-line through thecentre of the bottom part and the axis of the via

43、l at the upper edge of the flange; it is measured at the brim. cEdges slightly rounded. Figure 1 Typical example of injection vial madeof glass tubing containing a neck finishwithout blow back M odel ATable 1 Dimensions, overflow capacity and massOverflowcapacitya d1d2d3d4h1h2h3r1r2s1s2t Massml mm m

44、m mm mm mm mm mm mm mm mm mm mm mm gSizedesignation ofinjection vialtol tol. 0,20,3+max. 0,2 tol. min.tol. tol. min.max 2R 4 35 22 5 4R 6 1 16 0,15 13 10,5 7 45 32 8 2,5 1,5 0,6 6,1 6R 10 40 26 8,3 8R 11,5 0,522 45 31 8,5 3,5 9,4 10R 13,5 45 30 10,215R 19 1 1,2 24 0,2 16,5 60 0,545 9 0,5 4,0 2 1 0,0

45、40,7 12,820R 26 55 35 17,425R 32,5 65 45 20 30R 37,5 1,5 1,5 30 0,2520 17,5 12,6 75 0,755 10 0,75 5,5 2,5 1,2 0,050,7 1 22,7BS EN 15649-6:2009+A1:2013EN 15649-6:2009+A1:2013 (E)2 ISO 2009 All rights reservedBS EN 15649-6:2009+A1:2013EN 15649-6:2009+A1:2013 (E)3 ISO 2009 All rights reservedISO 8362-1

46、:2009/Amd.1:2015(E)Table 1 Dimensions,overflowcapacityandmassSizedesig-na-tionofinjec-tionvialOverflowcapacitymlammd1mmd2mm+0,20,3d3mmmax.d4mm0,2h1mmh2mmmin.h3mmr1mmr2mms1mms2mmmin.tmmmax.Massa,btol.tol.tol.tol.tol.2R40,51160,151310,57350,52280,52,51,510,040,60,74,44R645325,76R101,2220,22016,512,640

47、268,53,520,77,98R11,545318,710R13,5124453094,09,515R19604512,020R261,51,5300,2517,5550,735100,755,52,51,20,05116,225R32,5654518,930R37,5755521,950R6242,5400,42017,5c12,6730,7549100,756,04,01,50,070,91,534,5100R12373,5470,52017,5c12,61000,7575100,756,54,01,70,070,91,560,0aMean values that can deviate

48、 about 10%.bThe mass specifications apply to injection vials made of colourless borosilicate glass having a linear expansion coefficient of 5,1x106K1andadensityof2,34g/cm3. The mass of vials made of other glass types (e.g. amber glass or borosilicate glass 3.3) needs to be calculated using the densi

49、ty of the particular glass.cWith blow back Type B: 17,7mm. The slightly larger diameter is necessary due to the different hot-forming process with more glass mass having tobe formed.2 ISO 2015 All rights reservedTable 1 Dimensions, overflow capacity and massBS EN ISO 8362-1:2009ISO 8362-1:2009(E) ISO 2009 All rights reserved 3Dimensions in millimetres aThe perpendicularity tolerance a (as defined in ISO 1101) is a limit for the deviation o