1、July 2011 Translation by DIN-Sprachendienst.English price group 8No 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).ICS 11
2、.040.20!$sB“1805831www.din.deDDIN EN ISO 8362-6Injection containers and accessories Part 6: Caps made of aluminium-plastics combinations for injectionvials (ISO 8362-6:2010)English translation of DIN EN ISO 8362-6:2011-07Injektionsbehltnisse und Zubehr Teil 6: Brdelkappen aus Aluminium-Kunststoffkom
3、binationen fr Injektionsflaschen(ISO 8362-6:2010)Englische bersetzung von DIN EN ISO 8362-6:2011-07Rcipients et accessoires pour produits injectables Partie 6: Capsules pour flacons dinjection fabriques en un mlange aluminium-plastique(ISO 8362-6:2010)Traduction anglaise de DIN EN ISO 8362-6:2011-07
4、SupersedesDIN ISO 8362-6:1993-06www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.1107.11 DIN EN ISO 8362-6:2011-07 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO
5、/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use” (Secretariat: DIN, Germany) in collaboration with CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Norme
6、nausschuss Medizin (Medical Standards Committee), Working Committee NA 063-02-15 AA Elastomere Pharmapackmittel und zugehrige Komponenten. DIN EN ISO 8362 consists of the following parts, under the general title Injection containers and accessories: Part 1: Injection vials made of glass tubing Part
7、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 Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part In additi
8、on, the DIN ISO 8362 series Injection containers and accessories includes: 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 2768-1 DIN ISO 2768-1 ISO 2768-2 DIN ISO 2768-2 ISO 8362-3 DIN
9、 EN ISO 8362-3 ISO 8872 DIN EN ISO 8872 ISO 10985 DIN ISO 10985 Amendments This standard differs from DIN ISO 8362-6:1993-06 as follows: a) normative references have been updated; b) the standard has been editorially revised. Previous editions DIN ISO 8362-6: 1993-06 DIN EN ISO 8362-6:2011-07 3 Nati
10、onal Annex NA (informative) Bibliography DIN EN ISO 8362-3, Injection containers for injectables and accessories Part 3: Aluminium caps for injection vials DIN EN ISO 8872, Aluminium caps for transfusion, infusion and injection bottles General requirements and test methods DIN ISO 2768-1, General to
11、lerances Part 1: Tolerances for linear and angular dimensions without individual tolerance indications DIN ISO 2768-2, General tolerances Part 2: Geometrical tolerances for features without individual tolerances indications DIN ISO 10985, Caps made of aluminium-plastics combinations for infusion bot
12、tles and injection vials Requirements and test methods DIN EN ISO 8362-6:2011-07 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8362-6 April 2011 ICS 11.040.20 English Version mlange aluminium-plastique (ISO 8362-6:2010) Injektionsbehltnisse und Zubehr -
13、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 European Standard th
14、e 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 versions (English, Fren
15、ch, 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, Belgium, Bulgaria,
16、 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 COMMITTEE FOR STAN
17、DARDIZATION 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: EInjection containers and accessor
18、ies - 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 Contents Page Foreword3 Introduction .4 1 Scope 5 2 Normative references 5 3 Classification
19、 of types.5 4 Dimensions and tolerances 6 4.1 Dimensions.6 4.2 Tolerances 6 5 Designation 7 6 Requirements.7 6.1 General requirements7 6.2 Forces required to remove tab.7 7 Packaging .7 8 Marking .7 DIN EN ISO 8362-6:2011-07 EN ISO 8362-6:2011 (E) 2 Foreword The text of ISO 8362-6:2010 has been prep
20、ared 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 taken over as EN ISO 8362-6:2011 by Technical Committee CEN/TC 205 “Non-active medic
21、al 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, and conflicting national standards shall be withdrawn at the latest by October 20
22、11. 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. According to the CEN/CENELEC Internal Regulations, the national standards organiza
23、tions 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, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portug
24、al, 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. DIN EN ISO 8362-6:2011-07 EN ISO 8362-6:2011 (E) 3 Introduction The materials from which injec
25、tion 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 are not considered as primary packaging materials in direct contact with pharmaceutical preparations
26、. DIN EN ISO 8362-6:2011-07 EN ISO 8362-6:2011 (E) 4 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
27、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 2768-1, General tolerances Part 1: Tolerances for linear and angular dimensions without individual tolerance indications
28、ISO 2768-2, General tolerances Part 2: Geometrical 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 requir
29、ements and test methods ISO 10985, Caps made of 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
30、 cap with complete tear-off tab and plastics component. DIN EN ISO 8362-6:2011-07 EN ISO 8362-6:2011 (E) 5 4 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 sh
31、own in Figure 1 is informative 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
32、cap Dimensions in millimetres 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 b
33、y more than 0,25 mm. The extreme 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
34、 h2shall be agreed upon between 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. DIN EN ISO 8362-6:2011-07 EN ISO 8362-6:2011 (E) 6 5 Designation Aluminium-plastics caps shall be designated according to type; t
35、he designation 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 IS
36、O 8362 is 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
37、, shall be 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 i
38、ncoming control, 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 F
39、orces in newtons 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 ISO 8872 and the designation shall be as specified in Clause 5. DIN EN ISO 8362-6:2011-07 EN ISO 8362-6:2011 (E) 7
