1、March 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 1
2、1.040.25!$n9Y“1752254www.din.deDDIN EN ISO 8362-7Injection containers and accessories Part 7: Injection caps made of aluminium-plastics combinations withoutoverlapping plastics part (ISO 8362-7:2006)English translation of DIN EN ISO 8362-7:2011-03Injektionsbehltnisse und Zubehr Teil 7: Brdelkappen a
3、us Aluminium-Kunststoffkombinationen fr Injektionsflaschen ohneberstehendes Kunststoffteil (ISO 8362-7:2006)Englische bersetzung von DIN EN ISO 8362-7:2011-03Rcipients et accessoires pour produits injectables Partie 7: Capsules dinjection en combinaison aluminium-plastique avec lment plastiquenon db
4、ordant (ISO 8362-7:2006)Traduction anglaise de DIN EN ISO 8362-7:2011-03SupersedesDIN ISO 8362-7:2007-06www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.1203.11 DIN EN ISO 8362-7:2011-03 2 A comma is used as the decimal marker. Nati
5、onal foreword This standard has been prepared by Technical Committee ISO/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
6、). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-02-15 AA Gummi. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 2768-1 DIN ISO 2768-1 ISO
7、 2768-2 DIN ISO 2768-2 ISO 7500-1 DIN EN ISO 7500-1 ISO 8362-1:2003 DIN EN ISO 8362-1:2004-09 ISO 8362-3 DIN EN ISO 8362-3 ISO 8362-4:2003 DIN EN ISO 8362-4:2004-11 ISO 8362-6 DIN ISO 8362-6 ISO 8872:2003 DIN EN ISO 8872:2003-12 Amendments This standard differs from DIN ISO 8362-7:2007-06 as follows
8、: a) the European foreword has been included. Previous editions DIN ISO 8362-7: 1996-05, 2007-06 DIN EN ISO 8362-7:2011-03 3 National Annex NA (informative) Bibliography DIN ISO 2768-1, General tolerances Tolerances for linear and angular dimensions without individual tolerance indications DIN ISO 2
9、768-2, General tolerances Geometrical tolerances for features without individual tolerances indications DIN EN ISO 7500-1, Metallic materials Verification of static uniaxial testing machines Part 1: Tension/ compression testing machines Verification and calibration of the force-measuring system DIN
10、EN ISO 8362-1:2004-09, Injection containers and accessories Part 1: Injection vials made of glass tubing DIN EN ISO 8362-3, Injection containers for injectables and accessories Part 3: Aluminium caps for injection vials DIN EN ISO 8362-4:2004-11, Injection containers and accessories Part 4: Injectio
11、n vials made of moulded glass DIN ISO 8362-6, Injection containers for injectables and accessories Caps made of aluminium-plastics combinations for injection vials DIN EN ISO 8872:2003-12, Aluminium caps for transfusion, infusion and injection bottles General require-ments and test methods DIN EN IS
12、O 8362-7:2011-03 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8362-7 December 2010 ICS 11.040.20 English Version Injection containers and accessories Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part (ISO 8
13、362-7:2006) Rcipients et accessoires pour produits injectables Partie 7: Capsules dinjection en combinaison aluminium-plastique avec lment plastique non dbordant (ISO 8362-7:2006) Injektionsbehltnisse und Zubehr Teil 7: Brdelkappen aus Aluminium-Kunststoffkombinationen fr Injektionsflaschen ohne ber
14、stehendes Kunststoffteil (ISO 8362-7:2006) This European Standard was approved by CEN on 21 November 2010. 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 alterati
15、on. 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 by
16、 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,
17、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 EUROPISCH
18、ES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8362-7:2010: EContents DIN EN ISO 8362-7:2011-03 EN ISO 8362-7:2010 (E) 2 Page Foreword3 Introducti
19、on .4 1 Scope 5 2 Normative references 5 3 Classification of types.5 4 Dimensions and tolerances 6 4.1 Dimensions.6 4.2 Tolerances 6 5 Designation 6 6 Requirements.7 6.1 General requirements7 6.2 Force required to remove plastics component and tear off tab completely .7 7 Packaging .7 8 Marking .7 F
20、oreword The text of ISO 8362-7:2006 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 taken over as EN ISO 8362-7:2010 by
21、 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 June 2011, and conflicting national standards
22、shall be withdrawn at the latest by June 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. According to the CEN/CENELEC Internal R
23、egulations, 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, Lithuania, Luxembourg,
24、 Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 8362-7:2006 has been approved by CEN as a EN ISO 8362-7:2010 without any modification. EN ISO 8362-7:2010 (E) DIN EN ISO 8362-7:2011-03 3
25、Introduction 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, injection caps are not considered as primary packaging materia
26、ls in direct contact with pharmaceutical preparations. During the processing of injection vials 2R and 4R, according to ISO 8362-1, and injection vials 6R, 8R, 10I, 5H, 7H and 8H, according to ISO 8362-1 and ISO 8362-4 respectively, difficulties may arise when using injection caps made of aluminium-
27、plastics combinations corresponding to ISO 8362-6 because the diameter d2of the plastics element is larger than the diameter d of the injection vial body. In order to avoid problems during the automatic working process, e.g. labelling of the vials or intermediate storage on a turntable, injection ca
28、ps made of aluminium-plastics combinations are designed in such a way that the plastics element does not overlap the diameter of the vial body. EN ISO 8362-7:2010 (E) DIN EN ISO 8362-7:2011-03 4 1 Scope This part of ISO 8362 specifies aluminium-plastics combinations for the injection caps of injecti
29、on vials, as specified in ISO 8362-1 and ISO 8362-4, where the plastics part does not overlap the diameter of the vial body. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For und
30、ated 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: Geometrical tolerances for features w
31、ithout individual tolerance indications ISO 7500-1, Metallic materials Verification of static uniaxial testing machines Part 1: Tension/compression testing machines Verification and calibration of the force-measuring system ISO 8362-1:2003, Injection containers and accessories Part 1: Injection vial
32、s made of glass tubing ISO 8362-3, Injection containers and accessories Part 3: Aluminium caps for injection vials ISO 8362-4:2003, Injection containers and accessories Part 4: Injection vials made of moulded glass ISO 8362-6, Injection containers for injectables and accessories Part 6: Caps made of
33、 aluminium-plastics combinations for injection vials ISO 8872:2003, Aluminium caps for transfusion, infusion and injection bottles General requirements and test methods 3 Classification of types Injection caps shall be classified as follows: Type OB: Aluminium cap with central opening, and without o
34、verlapping plastics component; Type OD: Aluminium cap with complete tear-off tab, and without overlapping plastics component. EN ISO 8362-7:2010 (E) DIN EN ISO 8362-7:2011-03 5 4 Dimensions and tolerances 4.1 Dimensions All cover versions (flat, ring-shaped or other) of injection caps shall meet the
35、 dimensions given in Figure 1 and Table 1. The dimensions of injection vials made of glass tubing shall be in accordance with ISO 8362-1:2003, Clause 4. The dimensions of injection vials made of moulded glass shall be in accordance with ISO 8362-4:2003, Clause 4. NOTE The configuration of the inject
36、ion cap shown in Figure 1 is informative only. 4.2 Tolerances The tolerances shall be in accordance with ISO 2768-1 and ISO 2768-2. 5 Designation Aluminium-plastics injection caps shall be designated according to type: the designation shall be expressed as the word “cap“, the number and part of this
37、 International Standard followed by the type letters, followed by the nominal size of the container. EXAMPLE A type OD aluminium-plastics injection cap of nominal size 13 complying with the requirements laid down in this part of ISO 8362 is designated: Cap ISO 8362-7-OD-13 Dimensions in millimetres
38、a) Type OB b) Type OD Key 1 plastics component 2 aluminium injection cap in accordance with ISO 8362-3 3 score line NOTE For dimensions of parameters, see Table 1. Figure 1 Configuration of injection cap EN ISO 8362-7:2010 (E) DIN EN ISO 8362-7:2011-03 6 Table 1 Dimensions of injection cap Dimension
39、s in millimetres Parameters d2ad3be ch1h2dNominal size d10,10+min. max. min. max. min. max. 0,2 min. max. 13 13,3 13 15,8 3 8 6,3 7,3 8,4 20 20,3 20 20,9 6 10 0,168 0,242 7,3 8,7 9,8 aThe diameter d2shall be agreed between the manufacturer and user. It shall not differ from the nominal value by more
40、 than 0,25 mm. The extreme limits are given without tolerance. bAfter plastics element removal. The diameter d3shall be agreed between the manufacturer and user. cThe thickness e shall be agreed between the manufacturer and user. It shall not differ from the nominal value by more than 0,022 mm. The
41、extreme limits are given without tolerance. dThe height h2shall be agreed 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. 6 Requirements 6.1 General requirements The requirements shall be in accordance
42、 with ISO 8362-6, with the exception of the force required to remove the plastics component and tear off the tab completely, and the corresponding test. 6.2 Force required to remove plastics component and tear off tab completely 6.2.1 The force required to remove the plastics component and tear off
43、the tab completely is determined in a traction/pressure test machine class 1, in accordance with ISO 7500-1, with a special attachment as shown for example in Figure 2, with a traction speed, v, of 100 mm/min over a measuring range of 100 N. The values shall be in accordance with Tables 2 and 3. 6.2
44、.2 For incoming control of as-received injection caps, the 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. 7 Packaging Packaging shall comply with th
45、e requirements of ISO 8872. 8 Marking Marking shall be in accordance with ISO 8872 and the designation shall be as specified in Clause 5. EN ISO 8362-7:2010 (E) DIN EN ISO 8362-7:2011-03 7 a) Test set up b) Placement of pressure bar c) Pressure bar Key 1 pressure bar 2 clamp jaws 3 direction of trac
46、tive force 4 bottle 5 aluminium injection cap 6 plastics component Figure 2 Example of equipment to determine force required to remove plastics component and tear off tab completely Table 2 Dimensions of pressure bar Dimensions in millimetresNominal size r b 13 5 8 20 9 10 Table 3 Force required to remove plastics component and tear off tab completely Force in newtonsNominal size Force required to remove plastics component max. Force required to tear off tab completely max. 13 25 30 20 35 40 EN ISO 8362-7:2010 (E) DIN EN ISO 8362-7:2011-03 8
