1、BS EN ISO8362-1:2009ICS 11.040.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDInjection containersand accessoriesPart 1: Injection vials made of glasstubing (ISO 8362-1:2009)Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 29/03/2010 08:07, Uncontrolled
2、 Copy, (c) BSIThis British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 28 February2010. BSI 2010ISBN 978 0 580 67216 3Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 8362-1:2009National forewordThis British Standard is the UK implemen
3、tation of EN ISO 8362-1:2009.It supersedes BS EN ISO 8362-1:2004 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purp
4、ort to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 29/03/2010 08:07, Uncontrolled Copy, (c) BSIEUROPEAN STAN
5、DARD NORME EUROPENNE EUROPISCHE NORM EN 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 - Partie 1: Flacons en
6、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 national standards may be obtained on application to the CEN Management Centre or to any CEN member. This European Standard exists in three official versi
8、ons (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,
9、 Bulgaria, 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 STA
10、NDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management 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: ELicensed Copy: Wang Bin, ISO/EXC
11、HANGE CHINA STANDARDS, 29/03/2010 08:07, Uncontrolled Copy, (c) BSIBS EN ISO 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 for medical and pharmaceutical use“. This Eur
12、opean Standard shall be given the status of a national standard, either by publication of an identical text or 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
13、 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 8362-1:2004. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
14、 countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia
15、, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 8362-1:2009 has been approved by CEN as a EN ISO 8362-1:2009 without any modification. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 29/03/2010 08:07, Uncontrolled Copy, (c) BSIBS EN ISO 8362-1:2009ISO 8
16、362-1:2009(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 ISO technical committees. Each mem
17、ber 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 with the International El
18、ectrotechnical 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. Draft International Standards ado
19、pted 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 document may be the subject of pat
20、ent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 8362-1 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This third edition cancels and replaces the second edition (ISO 836
21、2-1:2003), which has undergone minor revision by including further types of neck finishes for injection vials model B neck finish with blow back (European style) and model C neck finish with blow back (American style). ISO 8362 consists of the following parts, under the general title Injection conta
22、iners 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-plastics combinations fo
23、r injection vials Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 29/03/2010 08:07, Uncontrolled Copy, (c) BSIBS EN ISO 8362-1:2009ISO 8362-1:2009(E) iv ISO 2009 All rights reservedIntroduction Th
24、e 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 suitable for the packaging and storage of injectable preparations until they are administered for medicin
25、al 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 chemical resistance whereas others made from soda-lime glass will have a lower, but adequate, chemical r
26、esistance 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 production aimed at producing a chemical resistance equal to that of those made from borosilicate glass for si
27、ngle 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. Because containers may be made from different types of glass and because it is the chemical behaviour of th
28、e 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 recommended in this part of ISO 8362 permit this performance, based on the hydrolytic resistance to be measure
29、d 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 stage, whether the hydrolytic resistance is produced by the composition of the glass as a material or by
30、 a treatment of the internal surface. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 29/03/2010 08:07, Uncontrolled Copy, (c) BSIBS 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 g
31、lass tubing 1 Scope This part of ISO 8362 specifies the form, dimensions and capacities of glass vials 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 colourles
32、s or amber glass containers made from borosilicate or soda-lime glass, made from glass tubing, whether internally 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
33、are indispensable for the application of this document. For dated references, only the edition cited applies. 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 clas
34、sification ISO 720, Glass Hydrolytic resistance of glass grains at 121 C Method of test and 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 surf
35、aces of glass containers Part 1: Determination by titration method and classification ISO 4802-2, Glassware Hydrolytic 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
36、 terms and definitions given in ISO 4802-1 and ISO 4808-2 apply. 4 Dimensions The dimensions of injection vials 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. Licensed Cop
37、y: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 29/03/2010 08:07, Uncontrolled Copy, (c) BSIBS EN ISO 8362-1:2009ISO 8362-1:2009(E) 2 ISO 2009 All 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 cyli
38、ndrical 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 diameter does not exceed the smaller one by more than 0,3 mm. bThe perpendicularity to
39、lerance 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 slightly rounded. Figure 1 Typical example of injection vial made of glass tubing conta
40、ining a neck finish without blow back Model A Table 1 Dimensions, overflow capacity and mass Overflow capacity a d1d2d3d4h1h2h3r1r2s1s2t Massml mm mm mm mm mm mm mm mm mm mm mm mm mm g Sizedesignation 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 1
41、3 10,5 7 45 32 8 2,5 1,5 0,6 6,1 6R 10 40 26 8,3 8R 11,5 0,5 22 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 0,04 0,7 12,820R 26 55 35 17,425R 32,5 65 45 20 30R 37,5 1,5 1,5 30 0,25 20 17,5 12,6 75 0,755 10 0,75 5,5 2,5 1,2 0,05 0,7 1 22,7Licensed Copy: Wang B
42、in, ISO/EXCHANGE CHINA STANDARDS, 29/03/2010 08:07, Uncontrolled Copy, (c) BSIBS 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 of the plumb-line through the centre o
43、f the bottom part and the axis of the vial at the upper edge of the flange; it is measured at the brim. bEdges slightly rounded. cThis value should not exceed 0,4 mm in order to avoid the wall becoming too weak. This dimension has not been given as a requirement because it is not possible to measure
44、 it adequately. NOTE Figures 2 and 3 illustrate ideal presentations. The transition to blow back is not sharp-edged but slightly rounded. Figure 2 Typical example of injection vial made of glass tubing containing a neck finish with blow back (European style) Model B Licensed Copy: Wang Bin, ISO/EXCH
45、ANGE CHINA STANDARDS, 29/03/2010 08:07, Uncontrolled Copy, (c) BSIBS EN ISO 8362-1:2009ISO 8362-1:2009(E) 4 ISO 2009 All rights reservedDimensions in millimetres aThe perpendicularity tolerance a (as defined in ISO 1101) is a limit for the deviation of the plumb-line through the centre of the bottom
46、 part and the axis of the vial at the upper edge of the flange; it is measured at the brim. bEdges slightly rounded. Figure 3 Typical example of injection vial made of glass tubing containing a neck finish with blow back (American style) Model C 5 Designation EXAMPLE 1 An injection vial (model A), s
47、ize 10 (10R), made of amber glass (br) tubing of hydrolytic resistance container class ISO 4802 HC 1 (1) complying with the requirements specified in this part of ISO 8362 is designated as follows: Vial ISO 8362-1 A 10R br 1 EXAMPLE 2 An injection vial (model B), size 10 (10R), made of amber glass (
48、br) tubing of hydrolytic resistance container class ISO 4802 HC 1 (1) complying with the requirements specified in this part of ISO 8362 is designated as follows: Vial ISO 8362-1 B 10R br 1 EXAMPLE 3 An injection vial (model C), size 15 (15R), made of colourless (cl) glass of hydrolytic resistance c
49、ontainer class ISO 4802 HC 1 (1) complying with the requirements specified in this part of ISO 8362 is designated as follows: Vial ISO 8362-1 C 15R cl 1 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 29/03/2010 08:07, Uncontrolled Copy, (c) BSIBS EN ISO 8362-1:2009ISO 8362-1:2009(E) ISO 2009 All rights reserved 56 Material Colourless (cl) or amber (br) borosilicate glass or soda-lime glass of one of the following hydr
