1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 8362-4:2011Injection containers andaccessoriesPart 4: Injection vials made of mouldedglass (ISO 8362-4:2011)BS EN ISO 8362-4:2011 BRITISH STANDARDNational forewordThis
2、British Standard is the UK implementation of EN ISO8362-4:2011. It supersedes BS EN ISO 8362-4:2004 which iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained on request to its secret
3、ary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 73790 9ICS 11.040.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published
4、 under the authority of theStandards Policy and Strategy Committee on 30 September 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8362-4 September 2011 ICS 11.040.20 Supersedes EN ISO 8362-4:2004English Version Injection containers
5、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: Injektionsflaschen aus Httenglas (ISO 8362-4:2011) This European Standard
6、 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 alteration. Up-to-date lists and bibliographical references concerning such
7、 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 by translation under the responsibility of a CEN member into its own
8、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, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
9、 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 EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 B
10、russels 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: EBS EN ISO 8362-4:2011EN ISO 8362-4:2011 (E) 3 Foreword This document (EN ISO 8362-4:2011) has been prepared by Technical Committee ISO/TC 76 “Transfusio
11、n, infusion and injection, 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
12、be withdrawn at the 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.
13、 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, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Irelan
14、d, 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 8362-4:2011 has been approved by CEN as a EN ISO 8362-4:2011 without any modification. BS EN ISO 8
15、362-4:2011ISO 8362-4:2011(E) ISO 2011 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 commi
16、ttees. Each member 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 I
17、nternational 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. Draft Internationa
18、l Standards adopted 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
19、 subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 8362-4 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use. This third edition cancels and
20、 replaces the second edition (ISO 8362-4:2003), of which it constitutes a minor revision. The principle changes to the second edition are the updating of normative references to ISO 4802-1 and ISO 4802-2, and the revision of Figure 2 and Table 2. ISO 8362 consists of the following parts, under the g
21、eneral 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 alumin
22、ium-plastics combinations for injection vials Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part BS EN ISO 8362-4:2011ISO 8362-4:2011(E) iv ISO 2011 All rights reservedIntroduction The purpose of this part of ISO 8362 is to specify the shape, dimensions
23、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 injectable preparations until they are administered for medicinal purposes. Such containers can be made from di
24、fferent 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 made from soda-lime-silica glass will have a lower chemical resistance but one that is adequate for the purpo
25、se 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 produce a chemical resistance equal to that of containers made from borosilicate glass for single use. This lev
26、el 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. Because containers can be made from different types of glass and because it is the chemical behaviour of the
27、 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 specified in this part of ISO 8362 will allow this performance based on the hydrolytic resistance to be measured
28、 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 hydrolytic resistance is due to the composition of the glass, or to a treatment of the internal surface. BS EN ISO 8
29、362-4:2011INTERNATIONAL STANDARD ISO 8362-4:2011(E) ISO 2011 All rights reserved 1Injection containers and accessories Part 4: Injection vials made of moulded glass 1 Scope This part of ISO 8362 specifies the shape, dimensions and capacities of glass vials for injectable preparations. It also specif
30、ies the material from 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, s
31、torage 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. For undated references, the latest edition of the referenced document (
32、including any amendments) 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
33、 surfaces of glass 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 resista
34、nce Test methods ISO 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. BS EN ISO 8362-4:2011ISO 8362-4:2011(E) 2 ISO 2011 All rights r
35、eserved4 Dimensions and designation 4.1 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 designat
36、ion of the hydrolytic resistance container 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) i
37、s a limit for the 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. cThe identification marks and/or coding may be on the bottom, the neck or the shoulder of the injection vial. The drawing r
38、epresents a typical example. dEdges slightly rounded. Figure 1 Typical example of injection vial for insulin BS EN ISO 8362-4:2011ISO 8362-4:2011(E) ISO 2011 All rights reserved 3Table 1 Dimensions and overflow capacity of injection vials for insulin Dimensions in millimetres Size designation for in
39、jection vial Overflow capacity ml min. a d h1h2r1ar2ar3at 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 injectio
40、n vial for insulin, size 5 (designated by 5I), made of moulded 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 anti
41、biotics 4.2.1 Dimensions The dimensions of injection vials 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. BS EN ISO 8362-4:2011ISO 8362-4:2011(E) 4 ISO 2011 All rights reservedDimensions in millimetres Key 1 ISO logo (option
42、al) 2 designation of the hydrolytic resistance container class (mandatory for 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
43、 The perpendicularity tolerance a (as defined in ISO 1101) is a limit for the 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 inje
44、ction vials made of glass tubing and those made of moulded glass, the measuring 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 i
45、njection vials made of glass tubing. But, in practice, the same aluminium caps 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
46、 Typical example of injection vial for antibiotics BS EN ISO 8362-4:2011ISO 8362-4:2011(E) ISO 2011 All rights reserved 5Table 2 Dimensions and overflow capacity of injection vials for antibiotics Dimensions in millimetres Size designation for injection vial Overflow capacityml min. a d h1h2h3r1ar2a
47、r3at tol. tol. min. min. 5H 6,3 1,1 20,8 0,4 41,3 0,5 26,2 6,5 8,4 1,5 10 1 7H 8,3 22,1 40,8 26,7 5 2 4,4 8H 9,2 1,2 23 46,8 29,5 9,5 1,5 7 10H 14 1,4 25,4 53,5 0,6 35,3 10 2 5 15H 16 1,5 26,5 0,45 58,8 36,5 15 2,5 9,5 20H 24,9 32 58 36,1 12 3 6,1 1,5 25H 30,9 36 0,5 34 6,5 30H 36,6 1,6 62,8 0,7 41,
48、3 4,3 50H 58,2 1,9 42,5 0,8 73 0,8 46 12,5 8,5 2 100H 116,2 2,4 51,6 94,5 0,9 58 25,6 4 7 aTolerances should be agreed between manufacturer and user. 4.2.2 Designation EXAMPLE An injection vial for antibiotics, size 10 (designated by 10H), made of amber moulded glass (br) of hydrolytic resistance co
49、ntainer class ISO 4802 HC 1 (designated by 1), complying with the requirements of this part of ISO 8362 is designated as follows: Vial ISO 8362-4 10H br 1 5 Material Injection vials shall be constructed from a) colourless (cl) or amber (br) borosilicate glass (see ISO 4802-1:2010, 3.6, and ISO 4802-2:2010, 3.6), or b) soda-lime-silica glass (see ISO 4802-1:2010, 3.7, and ISO 4802-2:2010, 3.7) of the following hydrolytic resistance grain classes: I
