DIN EN ISO 8362-1-2016 Injection containers and accessories - Part 1 Injection vials made of glass tubing (ISO 8362-1 2009 + Amd 1 2015) German version EN ISO 8362-1 2009 + A1 2015.pdf

1、English price group 10No 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 11.040.20!%VpJ“2517739www.din.deDIN EN ISO 83

2、62-1Injection containers and accessories Part 1: Injection vials made of glass tubing (ISO 8362-1:2009 + Amd 1:2015);English version EN ISO 8362-1:2009 + A1:2015,English translation of DIN EN ISO 8362-1:2016-06Injektionsbehltnisse und Zubehr Teil 1: Injektionsflaschen aus Rhrenglas (ISO 8362-1:2009

3、+ Amd 1:2015);Englische Fassung EN ISO 8362-1:2009 + A1:2015,Englische bersetzung von DIN EN ISO 8362-1:2016-06Rcipients et accessoires pour produits injectables Partie 1: Flacons en verre tir (ISO 8362-1:2009 + Amd 1:2015);Version anglaise EN ISO 8362-1:2009 + A1:2015,Traduction anglaise de DIN EN

4、ISO 8362-1:2016-06SupersedesDIN EN ISO 8362-1:2010-04www.beuth.deDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.June 2016Document comprises 15 pages 06.16DIN EN ISO 8362-1:2016-06 2 A comma is used as the decimal marker. National f

5、oreword This document (EN ISO 8362-1:2009 + A1:2015) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use”. The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (M

6、edical Standards Committee), Technical Committee NA 063-02-03 AA Verpackungssysteme fr die Befllung und Applikation von medizinischen Produkten. This standard includes Amendment A1 approved by CEN on 2015-10-03. The start and finish of text introduced or altered by amendment is indicated in the text

7、 by tags !“. DIN EN ISO 8362, Injection containers and accessories consists of the following parts: 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 closure

8、s for injection vials Part 6: Caps made of aluminium-plastics combinations for injection vials Part 7: Injections caps made of aluminium-plastics combinations without overlapping plastics parts The DIN Standards corresponding to the International Standards referred to in Clause 2 of this standard ar

9、e as follows: ISO 719 DIN ISO 719 ISO 720 DIN ISO 720 ISO 1101 DIN EN ISO 1101 ISO 4802-1 DIN ISO 4802-1 ISO 4802-2 DIN ISO 4802-2 Amendments This standard differs from DIN EN ISO 8362-1:2010-04 as follows: a) in Table 1, injection vials of sizes 50R and 100R have been added and the masses of all in

10、jection vials have been amended. Previous editions DIN EN ISO 8362-1: 1990-12 DIN EN ISO 8362-1: 2004-09, 2010-04 DIN EN ISO 8362-1 Corrigendum 1: 2005-02 DIN EN ISO 8362-1:2016-06 3 National Annex NA (informative) Bibliography DIN ISO 719, Glass Hydrolytic resistance of glass grains at 98 C Method

11、of test and classification DIN ISO 720, Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification DIN ISO 4802-1, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classification DIN ISO 4802-2, Gla

12、ssware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification DIN EN ISO 1101, Geometrical Product Specifications (GPS) Geometrical tolerancing Tolerances of form, orientation, location and run-out DIN EN ISO 8362-1:2016-06 4

13、 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8362-1 December 2009 + A1 December 2015 ICS 11.040.20 English Version Injection containers and accessories Part 1: Injection vials made of glass tubing (ISO 8362-1:2009 + Amd 1:2015) Rcipients et accessoires p

14、our produits injectables Partie 1: Flacons en verre tir (ISO 8362-1:2009 + Amd 1:2015) Injektionsbehltnisse und Zubehr Teil 1: Injektionsflaschen aus Rhrenglas (ISO 8362-1:2009 + Amd 1:2015) EN ISO 8362-1:2009 was approved by CEN on 2009-12-21 and Amendment A1:2015 on 2015-10-03. CEN members are bou

15、nd 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 national standards may be obtained on application to the C

16、EN-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 language and notified to the CEN-CENELEC Management Centre

17、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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

18、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-CENELEC Management Centre: Avenue Marnix 17, B-1000 B

19、russels 2015 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 + A1:2015 E EN ISO 8362-1:2009 + A1:2015 (E) 2 Contents Page Foreword to EN ISO 8362-1:2009 3 !European foreword to EN ISO 8362-1:2009/A1:2015“ 4 Introduc

20、tion 5 1 Scope 6 2 Normative references 6 3 Terms and definitions . 6 4 Dimensions 6 5 Designation. 10 6 Material 11 7 Performance 11 8 Requirements 11 8.1 Hydrolytic resistance 11 8.2 Annealing quality . 11 9 Marking 11 DIN EN ISO 8362-1:2016-06 EN ISO 8362-1:2009 + A1:2015 (E) 3 Foreword to EN ISO

21、 8362-1:2009 This document (EN ISO 8362-1:2009) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use”. This European Standard shall be given the status of a national standard, either by publication of an identical text o

22、r by endorsement, at the latest by June 2010, and conflicting national standards shall be withdrawn at the 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 be held responsible for i

23、dentifying any or all such patent rights. This document supersedes EN ISO 8362-1:2004. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic,

24、 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 United Kingdom. Endorsement notice The text of ISO 8362-1:2009 has been

25、approved by CEN as a EN ISO 8362-1:2009 without any modification.DIN EN ISO 8362-1:2016-06 EN ISO 8362-1:2009 + A1:2015 (E) 4 !European foreword to EN ISO 8362-1:2009/A1:2015“ !This document (EN ISO 8362-1:2009/A1:2015) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and in

26、jection, and 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

27、 standards 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

28、 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, Icela

29、nd, 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 8362-1:2009/Amd 1:2015 has been approved by CEN as a EN ISO 8362-1:2009/ A1:2015

30、 without any modification.“ DIN EN ISO 8362-1:2016-06 EN ISO 8362-1:2009 + A1:2015 (E) 5 Introduction The purpose of this part 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 s

31、uitable for the packaging and storage of injectable preparations until they are administered for medicinal purposes. Such containers may be made from different types of glass which can affect the chemical resistance properties; e.g., those made from borosilicate glass will have a very high level of

32、chemical resistance whereas others made from soda-lime glass will have a lower, but adequate, chemical resistance for the purpose for which they 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 produc

33、tion aimed at producing a chemical resistance equal to that of those made from borosilicate glass for single use. This level of chemical resistance is maintained as long as the interior surface is not destroyed by chemical attack, in which case it is reduced to that of untreated soda-lime glass. Bec

34、ause containers may be made from different types of glass and because it is the chemical behaviour of the internal surface which is important when they are filled with injectable preparations, it is essential to specify test procedures by which this performance can be measured. The procedures recomm

35、ended in this part of ISO 8362 permit this performance, based on the hydrolytic resistance to be measured and, from the result of measurement, it is possible to classify containers into their correct category. The procedure also allows containers to be tested and to determine, after an intermediate

36、stage, whether the hydrolytic resistance is produced by the composition of the glass as a material or by a treatment of the internal surface. DIN EN ISO 8362-1:2016-06 EN ISO 8362-1:2009 + A1:2015 (E) 6 1 Scope This part of ISO 8362 specifies the form, dimensions and capacities of glass vials for in

37、jectable 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-lime glass, made from glass tubing, whether intern

38、ally surface-treated or not, and intended to be used in the packaging, storage or transportation of products intended for injection. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies.

39、 For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 719, Glass Hydrolytic resistance of glass grains at 98 C Method of test and classification ISO 720, Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification IS

40、O 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 Part 1: Determination by titration method and classification ISO 4802-2, Glassware H

41、ydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification 3 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 injection via

42、ls made of glass tubing shall meet the requirements of Figure 1 or Figure 2 or Figure 3, as appropriate, and Table 1; the overflow capacity and mass shall be as shown in Table 1. DIN EN ISO 8362-1:2016-06 EN ISO 8362-1:2009 + A1:2015 (E) 7 Dimensions in millimetres aThe opening of the vial should ha

43、ve a constant diameter, over the entire distance, h3, i.e. it should exhibit a cylindrical shape. A slightly conical shape can be accepted if the following requirements are fulfilled: the truncated cone has the height h3; the larger diameter is located at the flange or as agreed upon; the larger dia

44、meter 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 the centre of the bottom part and the axis of the vial at the upper edge of the flange; it is measured at the brim. cEdges slig

45、htly rounded. Figure 1 Typical example of injection vial made of glass tubing containing a neck finish without blow back Model A DIN EN ISO 8362-1:2016-06 EN ISO 8362-1:2009 + A1:2015 (E) 8 !Table 1 Dimensions, overflow capacity and mass Size desig-nation of injection vial Overflow capacity ml a mm

46、d1mm d2mm +0,2 0,3 d3mm max. d4mm 0,2 h1mm h2mm min. h3mm r1mm r2mm s1mm s2mm min. t mm max. Massa,b tol. tol. tol. tol. tol. 2R 4 0,5 1 16 0,15 13 10,5 7 35 0,5 22 8 0,5 2,5 1,5 1 0,04 0,6 0,7 4,4 4R 6 45 32 5,7 6R 10 1,2 22 0,2 20 16,5 12,6 40 26 8,5 3,5 2 0,7 7,9 8R 11,5 45 31 8,7 10R 13,5 1 24 4

47、5 30 9 4,0 9,5 15R 19 60 45 12,0 20R 26 1,5 1,5 30 0,25 17,5 55 0,7 35 10 0,75 5,5 2,5 1,2 0,05 1 16,2 25R 32,5 65 45 18,9 30R 37,5 75 55 21,9 50R 62 4 2,5 40 0,4 20 17,5c12,6 73 0,75 49 10 0,75 6,0 4,0 1,5 0,07 0,9 1,5 34,5 100R 123 7 3,5 47 0,5 20 17,5c12,6 100 0,75 75 10 0,75 6,5 4,0 1,7 0,07 0,9

48、 1,5 60,0 aMean values that can deviate about 10 %. bThe mass specifications apply to injection vials made of colourless borosilicate glass having a linear expansion coefficient of 5,1 106K1and a density of 2,34 g/cm3. The mass of vials made of other glass types (e.g. amber glass or borosilicate gla

49、ss 3.3) needs to be calculated using the density of the particular glass. cWith blow back Type B: 17,7 mm. The slightly larger diameter is necessary due to the different hot-forming process with more glass mass having to be formed. “ DIN EN ISO 8362-1:2016-06 EN ISO 8362-1:2009 + A1:2015 (E) 9 Dimensions in millimetres aThe perpendicularity tolerance a (as defined in ISO 1101) is a limit for the deviation of the plumb-line throu