EN ISO 8362-7-2010 en Injection containers and accessories - Part 7 Injection caps made of aluminium-plastics combinations without overlapping plastics part《注射容器及附件 无重叠塑料部件的铝塑组合制成的.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 8362-7:2010Injection containers andaccessoriesPart 7: Injection caps made of aluminium-plastics combinations without overlappingplastics part (ISO 8362-7:2006)BS EN ISO

2、 8362-7:2010 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO8362-7:2010.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 secretary.

3、This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2010ISBN 978 0 580 71004 9ICS 11.040.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published und

4、er the authority of theStandards Policy and Strategy Committee on 31 December 2010.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8362-7 December 2010 ICS 11.040.20 English Version Injection containers and accessories - Part 7: Injection

5、 caps made of aluminium-plastics combinations without overlapping plastics part (ISO 8362-7:2006) 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

6、- Teil 7: Brdelkappen aus Aluminium-Kunststoffkombinationen fr Injektionsflaschen ohne berstehendes 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 condition

7、s for giving this European 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

8、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 language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards

9、 bodies of Austria, Belgium, 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 Unite

10、d Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES 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 8362-7:20

11、10: EBS EN ISO 8362-7:2010EN ISO 8362-7:2010 (E) 3 Foreword 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 (I

12、SO) and has been taken over as EN ISO 8362-7:2010 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 late

13、st by June 2011, and conflicting national standards 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 pa

14、tent rights. 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, Ice

15、land, Ireland, 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 8362-7:2006 has been approved by CEN as a EN ISO 8362-7:2010 without any modification.

16、 BS EN ISO 8362-7:2010ISO 8362-7:2006(E) ISO 2006 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 tec

17、hnical committees. 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 closel

18、y with the International 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

19、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 drawn to the possibility that some of the elements of this documen

20、t may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 8362-7 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This second edition cancels and replaces

21、 the first edition (ISO 8362-7:1995), of which it constitutes a minor revision. 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 for injecti

22、on 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 8362-7:2010ISO

23、 8362-7:2006(E) iv ISO 2006 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, injection caps

24、are not considered as primary packaging materials 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 ari

25、se when using injection caps made of aluminium-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 in

26、termediate storage on a turntable, injection caps made of aluminium-plastics combinations are designed in such a way that the plastics element does not overlap the diameter of the vial body. BS EN ISO 8362-7:2010INTERNATIONAL STANDARD ISO 8362-7:2006(E) ISO 2006 All rights reserved 1Injection contai

27、ners and accessories Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part 1 Scope This part of ISO 8362 specifies aluminium-plastics combinations for the injection caps of injection vials, as specified in ISO 8362-1 and ISO 8362-4, where the plastics part

28、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 undated references, the latest edition of the referenced document (including any

29、 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 without individual tolerance indications ISO 7500-1, Metallic materials Verifi

30、cation 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 vials made of glass tubing ISO 8362-3, Injection containers and accessories Part

31、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 aluminium-plastics combinations for injection vials ISO 8872:2003, Aluminium

32、 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 overlapping plastics component; Type OD: Aluminium cap with complete tear-off

33、tab, and without overlapping plastics component. BS EN ISO 8362-7:2010ISO 8362-7:2006(E) 2 ISO 2006 All rights reserved4 Dimensions and tolerances 4.1 Dimensions All cover versions (flat, ring-shaped or other) of injection caps shall meet the dimensions given in Figure 1 and Table 1. The dimensions

34、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 injection cap shown in Figure 1 is informative only. 4.2 Toleran

35、ces 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 International Standard followed by the type letters, foll

36、owed 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 a) Type OB b) Type OD Key 1 plastics component 2 aluminium

37、 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 BS EN ISO 8362-7:2010ISO 8362-7:2006(E) ISO 2006 All rights reserved 3Table 1 Dimensions of injection cap Dimensions in millimetres Parameters d2ad3be ch1

38、h2dNominal 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 than 0,25 mm. The extreme limits are g

39、iven 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 extreme limits are given without tolera

40、nce. 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 with ISO 8362-6, with the exception of

41、 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 the tab completely is determined in a t

42、raction/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. 6.2.2 For incoming control of as-received

43、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 the requirements of ISO 8872. 8 Marking M

44、arking shall be in accordance with ISO 8872 and the designation shall be as specified in Clause 5. BS EN ISO 8362-7:2010ISO 8362-7:2006(E) 4 ISO 2006 All rights reserveda) Test set up b) Placement of pressure bar c) Pressure bar Key 1 pressure bar 2 clamp jaws 3 direction of tractive force 4 bottle

45、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 comp

46、onent 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 BS EN ISO 8362-7:2010This page deliberately left blankThis page deliberately left blankBSI is the independent national body

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