1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 8362-6:2011Injection containers and accessoriesPart 6: Caps made of aluminium-plastics combinations for injection vials (ISO 8362-6:2010)BS EN ISO 8362-6:2011 BRITISH S
2、TANDARDNational forewordThis British Standard is the UK implementation of EN ISO 8362-6:2011. It is identical to ISO 8362-6:2010.The UK participation in its preparation was entrusted to T e c h n i c a l C o m m i t t e e C H / 2 1 2 , I V D s .A list of organizations represented on this committee c
3、an be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. BSI 2011 ISBN 978 0 580 64643 0 ICS 11.040.20 Compliance with a British Standard cannot confer immunity from legal ob
4、ligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2011.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8362-6 April 2011 ICS 11.040.20 English Version Inje
5、ction containers and accessories - Part 6: Caps made of aluminium-plastics combinations for injection vials (ISO 8362-6:2010) Rcipients et accessoires pour produits injectables - Partie 6: Capsules pour flacons dinjection fabriques en un mlange aluminium-plastique (ISO 8362-6:2010) Injektionsbehltni
6、sse und Zubehr - Teil 6: Brdelkappen aus Aluminium-Kunststoffkombinationen fr Injektionsflaschen (ISO 8362-6:2010) This European Standard was approved by CEN on 24 March 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this Eur
7、opean 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-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versio
8、ns (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 has the same status as the official versions. CEN members are the national standards bodies of Austria, B
9、elgium, Bulgaria, Croatia, 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 C
10、OMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES 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 8362-6:2011: EBS EN ISO 8362-6
11、:2011 EN ISO 8362-6:2011 (E) 3 Foreword The text of ISO 8362-6:2010 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use” of the International Organization for Standardization (ISO) and has been tak
12、en over as EN ISO 8362-6:2011 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. 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 October 2011,
13、and conflicting national standards shall be withdrawn at the latest by October 2011. 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. A
14、ccording 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, Ireland,
15、 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 8362-6:2010 has been approved by CEN as a EN ISO 8362-6:2011 without any modification. BS EN ISO 836
16、2-6:2011ISO 8362-6:2010(E) ISO 2010 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 committ
17、ees. 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 Int
18、ernational 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 International
19、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 s
20、ubject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 8362-6 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This second edition cancels and replaces the first edi
21、tion (ISO 8362-6:1992), Clause 2, 6.2 and Table 2 of which have been technically revised. ISO 8362 consists of the following parts, under 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 f
22、or 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 aluminium-plastics combinations without overlapping plastics part BS EN ISO 8362
23、-6:2011ISO 8362-6:2010(E) iv ISO 2010 All rights reservedIntroduction The materials from which injection containers (including elastomeric closures) are made are suitable primary packaging materials for storing injectable products until they are administered. However, in this part of ISO 8362, caps
24、are not considered as primary packaging materials in direct contact with pharmaceutical preparations. BS EN ISO 8362-6:2011INTERNATIONAL STANDARD ISO 8362-6:2010(E) ISO 2010 All rights reserved 1Injection containers and accessories Part 6: Caps made of aluminium-plastics combinations for injection v
25、ials 1 Scope This part of ISO 8362 specifies caps made of aluminium-plastics combinations for injection vials as specified in ISO 8362-1 and ISO 8362-4. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the ed
26、ition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 2768-1, General tolerances Part 1: Tolerances for linear and angular dimensions without individual tolerance indications ISO 2768-2, General tolerances Part 2: Geometric
27、al tolerances for features without individual tolerance indications ISO 8362-3, Injection containers and accessories Part 3: Aluminium caps for injection vials ISO 8872:2003, Aluminium caps for transfusion, infusion and injection bottles General requirements and test methods ISO 10985, Caps made of
28、aluminium-plastics combinations for infusion bottles and injection vials Requirements and test methods 3 Classification of types Caps shall be classified as follows: Type ZB: aluminium cap with central opening and plastics component; Type ZD: aluminium cap with complete tear-off tab and plastics com
29、ponent. BS EN ISO 8362-6:2011ISO 8362-6:2010(E) 2 ISO 2010 All rights reserved4 Dimensions and tolerances 4.1 Dimensions All cover versions (flat, ring-shaped or others) of caps shall meet the dimensions given in Figure 1 and Table 1. NOTE The configuration of the cap shown in Figure 1 is informativ
30、e only. 4.2 Tolerances The tolerances shall be in accordance with ISO 2768-1 and ISO 2768-2. Dimensions in millimetres Type ZB Type ZD Key 1 plastics component 2 aluminium cap in accordance with ISO 8362-3 3 score line Figure 1 Configuration of cap Table 1 Dimensions of cap Dimensions in millimetres
31、 d1d2ad3bech1h2dNominal size 0,10+min. max. min. max. min. max. 0,2 min. max. 13 13,3 15 16 3 8 6,3 7,3 8,4 20 20,3 22,2 23,2 6 10 0,168 0,242 7,3 8,7 9,8 aThe diameter d2shall be agreed upon between the manufacturer and user. It shall not differ from the nominal value by more than 0,25 mm. The extr
32、eme limits are given without tolerance. bAfter plastics element removal. cThe thickness e shall be agreed upon between the manufacturer and user. It shall not differ from the nominal value by more than 0,022 mm. The extreme limits are given without tolerance. dThe height h2shall be agreed upon betwe
33、en the manufacturer and user. It shall not differ from the nominal value by more than 0,3 mm. The extreme limits are given without tolerance. BS EN ISO 8362-6:2011ISO 8362-6:2010(E) ISO 2010 All rights reserved 35 Designation Aluminium-plastics caps shall be designated according to type; the designa
34、tion shall be expressed as the word “cap”, the number and part of this part of ISO 8362 followed by the type letters, followed by the nominal size of the container. For example, a Type ZD aluminium-plastics cap of nominal size 13 complying with the requirements laid down in this part of ISO 8362 is
35、designated as follows: Cap ISO 8362-6 - ZD - 13 6 Requirements 6.1 General requirements 6.1.1 The requirements for aluminium caps shall be in accordance with ISO 8362-3. 6.1.2 The requirements for plastics components, and the combination between the plastics component and the aluminium cap, shall be
36、 in accordance with ISO 10985. 6.1.3 Construction elements which penetrate into the interior space of the aluminium cap shall not interfere with the sealing process. 6.2 Forces required to remove tab 6.2.1 The maximum forces required to remove the tab shall comply with Table 2. 6.2.2 For incoming co
37、ntrol, a minimum value for the tear-off tab removal force shall be agreed between the supplier and user. The injection caps shall also withstand a sterilization process in accordance with ISO 8872:2003, 5.1. Table 2 Forces required to completely remove plastics component and tear-off tab Forces in n
38、ewtons Nominal size Force to remove plastics component (in accordance with ISO 10985) max. Force to remove tear-off tab completely(in accordance with ISO 8872) max. 13 20 25 35 30 40 7 Packaging Packaging shall comply with the requirements of ISO 8872. 8 Marking Marking shall be in accordance with I
39、SO 8872 and the designation shall be as specified in Clause 5. This page deliberately left blankThis page deliberately left blankBSI is the independent national body responsible for preparing British Standardsand other standards-related publications, information and services. It presents the UK view
40、 on standards in Europe and at the international level. It is incorporated by Royal Charter.British Standards Institution (BSI)raising standards worldwideBSI Group Headquarters389 Chiswick High Road London W4 4AL UKTel +44 (0)20 8996 9001Fax +44 (0)20 8996 Standards are updated by amendment or revi
41、sion. Users of British Stan-dards should make sure that they possess the latest amendments or editions.It is the constant aim of BSI to improve the quality of our products and serv-ices. We would be grateful if anyone finding an inaccuracy or ambiguity whileusing this British Standard would inform t
42、he Secretary of the technical com-mittee responsible, the identity of which can be found on the inside frontcover.Tel: +44 (0)20 8996 9001 Fax: +44 (0)20 8996 7001BSI offers Members an individual updating service called PLUS which ensuresthat subscribers automatically receive the latest editions of
43、standards.Tel: +44 (0)20 8996 7669 Fax: +44 (0)20 8996 7001Email: Buying standardsYou may buy PDF and hard copy versions of standards directly using acredit card from the BSI Shop on the website addition all orders for BSI, international and foreign standards publicationscan be addressed to BSI Cus
44、tomer Services.Tel: +44 (0)20 8996 9001 Fax: +44 (0)20 8996 7001Email: In response to orders for international standards, it is BSI policy tosupply the BSI implementation of those that have been publishedas British Standards, unless otherwise requested.Information on standardsBSI provides a wide ran
45、ge of information on national, Europeanand international standards through its Knowledge Centre.Tel: +44 (0)20 8996 7004 Fax: +44 (0)20 8996 7005Email: Various BSI electronic information services are also available whichgive details on all its products and services. Tel: +44 (0)20 8996 7111 Fax: +44
46、 (0)20 8996 7048Email: BSI Subscribing Members are kept up to date with standardsdevelopments and receive substantial discounts on the purchase priceof standards. For details of these and other benefits contact Membership Ad-ministration. Tel: +44 (0)20 8996 7002 Fax: +44 (0)20 8996 7001 Email: Inf
47、ormation regarding online access to British Standards via BritishStandards Online can be found at information about BSI is available on the BSI website at www.bsi- subsists in all BSI publications. BSI also holds the copyright,in the UK, of the publications of the international standardization bodi
48、es. Ex-cept as permitted under the Copyright, Designs and Patents Act 1988 no ex-tract may be reproduced, stored in a retrieval system or transmitted in anyform or by any means electronic, photocopying, recording or otherwise without prior written permission from BSI. This does not preclude the freeuse, in the course of implementing the standard of necessary details such assymbols, and size, type or grade designations. If these details are to be usedfor any other purpose than implementation then the prior written permissionof BSI must be obtained. Details and advice can
