1、BRITISH STANDARD BS EN ISO 8362-3:2003 Incorporating Corrigendum No. 1 Injection containers and accessories Part 3: Aluminium caps for injection vials The European Standard EN ISO 8362-3:2003 has the status of a British Standard ICS 11.040.20 BS EN ISO 8362-3:2003 This British Standard was published
2、 under the authority of the Standards Policy and Strategy Committee on 28 February 2003 BSI 1 May 2003 ISBN 0 580 41323 3 National foreword This British Standard is the official English language version of EN ISO 8362-3:2003. It is identical with ISO 8362-3:2001. It supersedes BS EN 28362-3:1993 whi
3、ch is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement inter
4、national or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purp
5、ort to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committe
6、e any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO
7、foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 3, the Annex ZA page, an inside back cover and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments 14471 Corr
8、igendum No. 1 1 May 2003 Replacing the EN ISO foreword page and the Annex ZA pageEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO83623 February2003 ICS11.040.20 SupersedesEN283623:1993 Englishversion InjectioncontainersandaccessoriesPart3:Aluminiumcaps forinjectionvials(ISO83623:2001) Rcipientse
9、taccessoirespourproduitsinjectablesPartie 3:Capsulesenaluminiumpourflacons(ISO83623:2001) InjektionsbehltnissefrInjektionsprparateundZubehr Teil3:AluminiumBrdelkappenfrInjektionsflaschen(ISO 83623:2001) ThisEuropeanStandardwasapprovedbyCENon27December2002. CENmembersareboundtocomplywiththeCEN/CENELE
10、CInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeo
11、fficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,Fran
12、ce,Germany,Greece, Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,SlovakRepublic,Spain,Sweden,Switzerland and UnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2003CEN
13、Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO83623:2003ECORRECTED20030326 Foreword ThetextofISO83623:2001hasbeenpreparedbyTechnicalCommitteeISO/TC76 “Transfusion,infusionandinjectionequipmentformedicalandpharmaceuticaluse“ofthe InternationalOrgani
14、zationforStandardization(ISO)andhasbeentakenoverasENISO8362 3:2003byCMC. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationof anidenticaltextorbyendorsement,atthelatestbyAugust2003,andconflictingnational standardsshallbewithdrawnatthelatestbyAugust2003. Thisdocumentsupe
15、rsedesEN283623:1993. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsof thefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Czech Republic,Denmark,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy, Luxembourg,Malta,Netherlands,Norway,P
16、ortugal,Slovakia,Spain,Sweden,Switzerlandand theUnitedKingdom. Endorsementnotice ThetextofISO83623:2001hasbeenapprovedbyCENasENISO83623:2003withoutany modifications. NOTENormativereferencestoInternationalStandardsarelistedinAnnexZA(normative). ENISO83623:2003INTERNATIONAL STANDARD ISO 8362-3 Second
17、edition 2001-12-01 Reference number ISO 8362-3:2001(E) Injection containers and accessories Part 3: Aluminium caps for injection vials Rcipients et accessoires pour produits injectables Partie 3: Capsules en aluminium pour flacons ENISO83623:2003ENISO83623:2003iiOSI -26381002:3)E( ISO 1002 All rithg
18、s rreseved iii Contents Page 1 Scope . 1 2 Normative reference . 1 3 Dimensions and designation 1 4 Requirements . 1 5 Packaging . 3 6 Marking . 3 ENISO83623:2003iiiISO -26382:3)E(100 vi ISO 1002 All rithgs rreseved Foreword ISO (the International Organization for Standardization) is a worldwide fed
19、eration of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that comm
20、ittee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accorda
21、nce with the rules given in the ISO/IEC Directives, Part 3. Draft International 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
22、drawn to the possibility that some of the elements of this part of ISO 8362 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 8362-3 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and
23、 injection equipment for medical and pharmaceutical use. This second edition cancels and replaces the first edition (ISO 8362-3:1989), which has been technically revised. ISO 8362 consists of the following parts, under the general title Injection containers and accessories: Part 1: Injection vials m
24、ade 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 for injection vials Part 7: Injection caps made of
25、 aluminium-plastics combinations without overlapping plastics part ENISO83623:2003ivOSI -26381002:3)E( ISO 1002 All rithgs rreseved v Introduction The materials from which injection containers (including the elastomeric closures) are made are suitable primary packaging materials for storing injectab
26、le products until they are administered. However, in this part of ISO 8362, aluminium caps are not considered as primary packaging materials in direct contact with pharmaceutical preparations. ENISO83623:2003vANRETNIITOLAN TSDNADRA OSI -26381002:3)E( ISO 1002 All rithgs rreseved 1 Injection containe
27、rs and accessories Part 3: Aluminium caps for injection vials 1 Scope This part of ISO 8362 specifies aluminium caps for injection vials as described in ISO 8362-1 and ISO 8362-4. 2 Normative reference The following normative document contains provisions which, through reference in this text, consti
28、tute provisions of this part of ISO 8362. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 8362 are encouraged to investigate the possibility of applying the most recent edition of the no
29、rmative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 8872, Aluminium caps for transfusion, infusion and injection bottles General requireme
30、nts and test methods 3 Dimensions and designation 3.1 Dimensions The dimensions of aluminium caps shall be as shown in Figure 1 and as given in Table 1. 3.2 Designation Aluminium caps are designated according to type: the four types A, B, C and D are illustrated in Figure 1. The designation is expre
31、ssed as the number and part of this International Standard, followed by the nominal size of the container, followed by the type letter. EXAMPLE A type B (i.e. two-bridge tab) aluminium cap (B) of nominal size 13 complying with the requirements laid down in this part of ISO 8362 is designated. Alumin
32、ium cap ISO 8362-3-13-B 4 Requirements 4.1 General The caps shall meet the requirements of ISO 8872. ENISO83623:20031ISO -26382:3)E(100 2 ISO 1002 All rithgs rreseved Dimensions in millimetres a) Type A Aluminium cap with centre hole b) Type B Aluminium cap with two-bridge tab Key 1 Tear-off perfora
33、tion c) Type C Aluminium cap with three-bridge tab d) Type D Aluminium cap with complete tear-off tab NOTE The width and the number of bridges for types B, C and D depend on the degree of resistance intended. Figure 1 Dimensions and configuration of aluminium caps ENISO83623:20032OSI -26381002:3)E(
34、ISO 1002 All rithgs rreseved 3 4.2 Force required to remove tab 4.2.1 Two- or three-bridge tabs (types B and C) The force needed to remove the tab shall be determined in accordance with ISO 8872 and shall be within the range given in Table 2. 4.2.2 Complete tear-off tab (type D) The force needed to
35、remove the tab completely shall be determined in accordance with ISO 8872 and shall be within the range given in Table 3. 5 Packaging The packaging of aluminium caps shall comply with the requirements of ISO 8872. 6M a r k i n g The aluminium caps shall be marked in accordance with ISO 8872 and with
36、 the designation as specified in 3.2. Table 1 Dimensions of aluminium caps Dimensions in millimetres Nominal size b a b Type A, B and C D 13 13,35 3 to 8 8 to 9 , 6,3 1,0 20 20,35 6 to 11 10 to 13 7,3 to 7,8 a The thickness shall be agreed between manufacturer and user within the given range. The th
37、ickness shall not differ from the nominal value by more than . The extreme limits are given without tolerance. b The diameter and the height shall be agreed between manufacturer and user. The dimensions shall not differ from the nominal value by more than . The extreme limits are given without toler
38、ance. Table 2 Minimum and maximum forces to remove tabs with two (type B) or three (type C) bridges F or c ei nn e w t ons Nominal size Force Type B tabs Type C tabs 13 and 20 25 60 46 76 Table 3 Minimum and maximum forces to remove cap of complete tear-off tab (type D) F or c ei nn e w t ons Nomina
39、l size Force to break bridges Force to tear off tab completely 13 and 20 30 a 50 5 25 a In the case of multiple bridges, the resistance against pressure shall be sufficient, but the individual breaking force will be reduced accordingly. d 1 +0,1 0,05 d 2 0,2 e h 0,2 r 0,2 0,242 max. 0,168 min. 0,022
40、 mm d 2 h 0,2 mm min. max. min. max. min. max. min. max. ENISO83623:20033AnnexZA (normative) Normativereferencestointernationalpublications withtheirrelevantEuropeanpublications ThisEuropeanStandardincorporatesbydatedorundatedreference,provisionsfromother publications.Thesenormativereferencesarecite
41、dattheappropriateplacesinthetextandthe publicationsarelistedhereafter.Fordatedreferences,subsequentamendmentstoorrevisionsof anyofthesepublicationsapplytothisEuropeanStandardonlywhenincorporatedinitby amendmentorrevision.Forundatedreferencesthelatesteditionofthepublicationreferredto applies(includin
42、gamendments). NOTEWhereanInternationalPublicationhasbeenmodifiedbycommonmodifications,indicated by(mod.),therelevantEN/HDapplies. Publication Year Title EN Year ISO8872 1988 Aluminium caps for transfusion, infusion andinjectionbottlesGeneral requirementsandtestmethods EN28872 1993 ENISO83623:2003BS
43、EN ISO 8362-3:2003 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing British Standards. It presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter. Revision
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