1、December 2011 Translation by DIN-Sprachendienst.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).I
2、CS 11.040.20!$xXp“1855377www.din.deDDIN EN ISO 8362-4Injection containers and accessories Part 4: Injection vials made of moulded glass (ISO 8362-4:2011)English translation of DIN EN ISO 8362-4:2011-12Injektionsbehltnisse und Zubehr Teil 4: Injektionsflaschen aus Httenglas (ISO 8362-4:2011)Englische
3、 bersetzung von DIN EN ISO 8362-4:2011-12Rcipients et accessoires pour produits injectables Partie 4: Flacons en verre moul (ISO 8362-4:2011)Traduction anglaise de DIN EN ISO 8362-4:2011-12SupersedesDIN EN ISO 8362-4:2004-11www.beuth.deDocument comprises 15 pagesIn case of doubt, the German-language
4、 original shall be considered authoritative.12.11 DIN EN ISO 8362-4:2011-12 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use” (Secretariat: DIN
5、, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-02-03 AA Verpackungssysteme fr die Befllung und Applikation von medizinischen Produkten. DIN EN ISO 8362 consists of the following parts, under
6、the general 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 6: Caps made of aluminium-plastics combinations for injection vials
7、Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part Part 5: Freeze drying closures for injection vials The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 719 DIN ISO 719 ISO 720 DIN ISO 720 ISO
8、1101 DIN EN ISO 1101 ISO 4802-1 DIN ISO 4802-1 ISO 4802-2 DIN ISO 4802-2 ISO 7458 DIN EN ISO 7458 ISO 7459 DIN EN ISO 7459 Amendments This standard differs from DIN EN ISO 8362-4:2004-11 as follows: a) normative references to ISO 4802-1 and ISO 4802-2 have been updated; b) the dimensions in Figure 2
9、 and Table 2 have been revised; c) in Clause 7 “Performance requirements”, a NOTE has been added stating that other test methods may be required by national or regional regulations. Previous editions DIN 58366-1: 1966-01, 1969-04, 1979-04 DIN 58366-5: 1979-06, 1981-02 DIN ISO 8362-4: 1990-09, 1991-0
10、8, 1996-07 DIN EN ISO 8362-4: 2004-09, 2004-11 DIN ISO 8362 consists of the following part, under the general title Injection containers and accessories: DIN EN ISO 8362-4:2011-12 3 National Annex NA (informative) Bibliography DIN EN ISO 1101, Geometrical Product Specifications (GPS) Geometrical tol
11、erancing Tolerances of form, orientation, location and run-out DIN EN ISO 7458, Glass containers Internal pressure resistance Test methods DIN EN ISO 7459, Glass containers Thermal shock resistance and thermal shock endurance Test methods DIN ISO 719, Glass Hydrolytic resistance of glass grains at 9
12、8 C Method 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
13、4802-2, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification DIN EN ISO 8362-4:2011-12 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8362-4 September 2011 ICS 11.040.2
14、0 Supersedes EN ISO 8362-4:2004English Version Injection containers and accessories - Part 4: Injection vials made of moulded glass (ISO 8362-4:2011) Rcipients et accessoires pour produits injectables - Partie 4: Flacons en verre moul (ISO 8362-4:2011) Injektionsbehltnisse und Zubehr - Teil 4: Injek
15、tionsflaschen aus Httenglas (ISO 8362-4:2011) This European Standard was approved by CEN on 31 August 2011. 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 alterat
16、ion. 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 (English, French, German). A version in any other language made b
17、y 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, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
18、 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 STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISC
19、HES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8362-4:2011: EContents Page Foreword3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms a
20、nd definitions .5 4 Dimensions and designation6 4.1 Injection vials for insulin.6 4.1.1 Dimensions.6 4.1.2 Designation 7 4.2 Injection vials for antibiotics 7 4.2.1 Dimensions.7 4.2.2 Designation 9 5 Material .9 6 Defects, sealing surfaces9 7 Performance requirements .10 7.1 Hydrolytic resistance 10
21、 7.2 Internal pressure resistance.10 7.3 Thermal shock resistance.10 7.4 Annealing quality.10 8 Marking .10 Bibliography 11 EN ISO 8362-4:2011 (E) DIN EN ISO 8362-4:2011-12 2 Foreword This document (EN ISO 8362-4:2011) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and inj
22、ection, and blood processing 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 or by endorsement, at the latest by March 2012, and conflicting national standards shall be withdrawn at the
23、 latest by March 2012. 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 8362-4:2004. According to the C
24、EN/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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, L
25、ithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 8362-4:2011 has been approved by CEN as a EN ISO 8362-4:2011 without any modification. EN ISO 8362-4:2011 (E) DIN EN
26、ISO 8362-4:2011-12 3 Introduction The purpose of this part of ISO 8362 is to specify the shape, dimensions and capacities of, and performance requirements for, glass vials intended for medical use. Containers made from moulded glass are considered to be suitable for the packaging and storage of inje
27、ctable preparations until they are administered for medicinal purposes. Such containers can be made from different types of glass, which can affect the chemical resistance properties. For example, those made from borosilicate glass will have a very high level of chemical resistance, whereas those ma
28、de from soda-lime-silica glass will have a lower chemical resistance but one that is adequate for the purpose for which the containers are intended. The chemical resistance of the internal surface of containers made from soda-lime-silica glass can be improved by a treatment during production to prod
29、uce a chemical resistance equal to that of containers made from borosilicate glass for single use. This level of chemical resistance will be maintained as long as the interior surface is not destroyed by chemical attack, in which case it will be reduced to that of untreated soda-lime-silica glass. B
30、ecause containers can be made from different types of glass and because it is the chemical behaviour of the internal surface that 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 speci
31、fied in this part of ISO 8362 will allow 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 procedures also allow containers to be tested and to determine whether the hydrolyti
32、c resistance is due to the composition of the glass, or to a treatment of the internal surface. EN ISO 8362-4:2011 (E) DIN EN ISO 8362-4:2011-12 4 1 Scope This part of ISO 8362 specifies the shape, dimensions and capacities of glass vials for injectable preparations. It also specifies the material f
33、rom which such containers are made and the performance requirements for the containers. It applies to colourless or amber glass containers moulded from borosilicate or soda-lime-silica glass, with or without an internal surface treatment, and intended to be used in the packaging, storage or transpor
34、tation 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. For undated references, the latest edition of the referenced document (including any amen
35、dments) applies. ISO 719:1985, Glass Hydrolytic resistance of glass grains at 98 C Method of test and classification ISO 720:1985, Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification ISO 4802-1:2010, Glassware Hydrolytic resistance of the interior surfaces of glass
36、 containers Part 1: Determination by titration method and classification ISO 4802-2:2010, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification ISO 7458, Glass containers Internal pressure resistance Test methods I
37、SO 7459, Glass containers Thermal shock resistance and thermal shock endurance Test methods 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 4802-1 and ISO 4802-2 apply. EN ISO 8362-4:2011 (E) DIN EN ISO 8362-4:2011-12 5 4 Dimensions and designation 4
38、.1 Injection vials for insulin 4.1.1 Dimensions The dimensions of injection vials for insulin shall be as shown in Figure 1 and as given in Table 1. The overflow capacity shall be as given in Table 1. Dimensions in millimetres Key 1 ISO logo (optional) 2 designation of the hydrolytic resistance cont
39、ainer class (mandatory for type I and type II optional for type III) 3 manufacturers code/designation of the mould 4 manufacturers trade-mark (optional) aDimension to be maintained over a depth of 1 mm. bThe perpendicularity tolerance a (as defined in ISO 1101) is a limit for the deviation of the pl
40、umb-line through the centre of the bottom of the vial and the axis of the vial at the upper edge of the flange. It is measured at the brim. cThe identification marks and/or coding may be on the bottom, the neck or the shoulder of the injection vial. The drawing represents a typical example. dEdges s
41、lightly rounded. Figure 1 Typical example of injection vial for insulin EN ISO 8362-4:2011 (E) DIN EN ISO 8362-4:2011-12 6 Table 1 Dimensions and overflow capacity of injection vials for insulin Dimensions in millimetres Size designation for injection vial Overflow capacity ml min. a d h1h2r1ar2ar3a
42、t tol. tol. min. 2l 2,5 1 18 0,5 30,6 0,6 17,6 7,9 1,6 2,5 0,4 5l 7,2 1,4 19 0,6 52,8 36,5 12,7 1,5 1,5 1 10l 13,1 1,6 23 0,6 58,9 42 10,3 2,5 1,5 aTolerances should be agreed between manufacturer and user. 4.1.2 Designation EXAMPLE An injection vial for insulin, size 5 (designated by 5I), made of m
43、oulded amber glass (br) of hydrolytic resistance container class ISO 4802 HC 1 (designated by 1), complying with the requirements specified in this part of ISO 8362, is designated as follows: Vial ISO 8362-4 5I br 1 4.2 Injection vials for antibiotics 4.2.1 Dimensions The dimensions of injection via
44、ls for antibiotics shall be as shown in Figure 2 and as given in Table 2. The overflow capacity shall be as given in Table 2. EN ISO 8362-4:2011 (E) DIN EN ISO 8362-4:2011-12 7 Dimensions in millimetres Key 1 ISO logo (optional) 2 designation of the hydrolytic resistance container class (mandatory f
45、or type I and type II optional for type III) 3 manufacturers code/designation of the mould 4 manufacturers trade-mark (optional) NOTE The base area can be grained or plain. a Dimension to be maintained over a depth of 1 mm. b The perpendicularity tolerance a (as defined in ISO 1101) is a limit for t
46、he deviation of the plumb-line through the centre of the bottom of the vial and the axis of the vial at the upper edge of the flange. It is measured at the brim. c Owing to the differences in manufacturing procedures for injection vials made of glass tubing and those made of moulded glass, the measu
47、ring point at the brim is different in each case. It follows that the height measured from the lower edge of the flange to the measuring point at the brim of injection vials made of moulded glass is 0,2 mm more than that of injection vials made of glass tubing. But, in practice, the same aluminium c
48、aps may be used for both types of vial. dThe identification marks and/or coding may be on the bottom, the neck or the shoulder of the injection vial. The drawing represents a typical example. eEdges slightly rounded. Figure 2 Typical example of injection vial for antibiotics EN ISO 8362-4:2011 (E) DIN EN ISO 8362-4:2011-12 8 Table 2 Dimensions and overflow capacity of injection vials for antibiotics Dimensions in millimetres Size d
