1、December 2009DEUTSCHE NORM English price group 6No part of this standard 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 11.040.20!$=“1562695ww
2、w.din.deDDIN ISO 10985Caps made of aluminium-plastics combinations for infusion bottles andinjection vials Requirements and test methods (ISO 10985:2009)English version of DIN ISO 10985:2009-12Brdelkappen aus Aluminium-Kunststoffkombinationen fr Infusions- undInjektionsflaschen Anforderungen und Prf
3、verfahren (ISO 10985:2009)Englische Fassung DIN ISO 10985:2009-12SupersedesDIN ISO 10985:2001-07www.beuth.deDocument comprises pages7DIN ISO 10985:2009-12 2National foreword This standard has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical an
4、d pharmaceutical use” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Technical Committee NA 063-02-09 AA Sekundrpackmittel und Zubehr. Attention is drawn to the possibility that some of the elements
5、of this document may be the subject of patent rights. DIN shall not be held responsible for identifying any or all such patent rights. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 7500-1 DIN EN ISO 7500-1 ISO 8362-1 DIN EN ISO 8362-1
6、 ISO 8362-4 DIN EN ISO 8362-4 ISO 8362-6 DIN ISO 8362-6 ISO 8536-1 DIN EN ISO 8536-1 ISO 8536-7 DIN ISO 8536-7 ISO 8872 DIN EN ISO 8872 Amendments This standard differs from DIN ISO 10985:2001-07 as follows: a) Clause 2 “Normative references” has been updated. b) The content of the International Sta
7、ndard ISO 8536-7:2009 has been adopted in its entirety. Previous editions DIN ISO 10985: 1993-06, 2001-07 National Annex NA (informative) Bibliography DIN EN ISO 7500-1, Metallic materials Verification of static uniaxial testing machines Part 1: Tension/compression testing machines Verification and
8、calibration of the force-measuring system DIN EN ISO 8362-1, Injection containers and accessories Part 1: Injection vials made of glass tubing DIN EN ISO 8362-4, Injection containers and accessories Part 4: Injection vials made of moulded glass DIN EN ISO 8536-1, Infusion equipment for medical use P
9、art 1: Infusion glass bottles DIN EN ISO 8872, Aluminium caps for transfusion, infusion and injection bottles General requirements and test methods DIN ISO 8362-6, Injection containers for injectables and accessories Caps made of aluminium-plastics combinations for injection vials DIN ISO 8536-7, In
10、fusion equipment for medical use Part 7: Caps made of aluminium-plastics combinations for infusion bottles Caps made of aluminium-plastics combinations for infusion bottles and injection vials Requirements and test methods Introduction The materials from which injection and infusion containers (incl
11、uding elastomeric closures) are made are suitable primary packaging materials for storing injectable products and infusion solutions until they are administered. However, in this International Standard, caps are not considered as primary packaging materials in direct contact with pharmaceutical prep
12、arations. DIN ISO 10985:2009-12 31 Scope This International Standard specifies general requirements and test methods for caps made of aluminium-plastics combinations in accordance with ISO 8536-7 or ISO 8362-6 intended for use respectively on infusion bottles as specified in ISO 8536-1 and/or inject
13、ion bottles as specified in ISO 8362-1 and ISO 8362-4. The purpose of this International Standard is to specify caps that provide: a) guarantee of originality of the closure up to the point of administration; b) compression of the sealing element (rubber closure) on to the sealing surfaces of the in
14、fusion and/or injection bottles; c) protection of the sealing element against soiling and mechanical damage; d) simple and injury-free opening of the closure in order to expose the penetration area of the rubber closure and/or to permit total removal of the cap. 2 Normative references The following
15、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 amendments) applies. ISO 7500-1, Metallic materials Verification of static uniaxial
16、testing machines Part 1: Tensile/compression testing machines Verification and calibration of the force-measuring system ISO 8362-1, Injection containers and accessories Part 1: Injection vials made of glass tubing ISO 8362-4, Injection containers and accessories Part 4: Injection vials made of moul
17、ded glass ISO 8362-6, Injection containers for injectables and accessories Part 6: Caps made of aluminium-plastics combinations for injection vials ISO 8536-1, Infusion equipment for medical use Part 1: Infusion glass bottles ISO 8536-7, Infusion equipment for medical use Part 7: Caps made of alumin
18、ium-plastics combinations for infusion bottles ISO 8872:2003, Aluminium caps for transfusion, infusion and injection bottles General requirements and test methods DIN ISO 10985:2009-12 43 Requirements 3.1 Aluminium component The aluminium component shall meet the requirements given in Clause 3 of IS
19、O 8872:2003. 3.2 Plastics component 3.2.1 Material Thermoplastics materials shall meet the producing countries regulations for use in non-contact pharmaceutical components. The material shall be steam-sterilizable at 121 C for 30 min. Plastics material shall withstand a temperature of 130 C for a sh
20、ort time (max. 5 min). 3.2.2 Quality of finish The plastics component shall be combined with the aluminium component such that complete joining is guaranteed. The plastics component shall not have sharp edges or non-permissible protruding moulding flash. 3.3 Aluminium-plastics cap combination On rem
21、oval of the plastics component, the opening exposed in the aluminium shell shall be so constructed that no injuries may occur during normal use. 4 Test methods 4.1 Aluminium component The results of the tests for the aluminium component shall meet the requirements given in 4.1 to 4.4 of ISO 8872:200
22、3. 4.2 Aluminium-plastics cap combination 4.2.1 Apparatus 4.2.1.1 Traction/pressure test machine, class 1 in accordance with ISO 7500-1, with special attachment as shown, for example, in Figure 1, where the traction speed, v, is 100 mm/min over a measuring range of 100 N. 4.2.2 Determination of forc
23、e required to pull off plastics component with central tear-out The caps are clamped in the special holder of the traction test machine, as shown in Figure 1, and the plastics component is pulled off with a metal finger of dimensions as given in Table 1. DIN ISO 10985:2009-12 5Key 1 direction of tra
24、ction 2 clamp jaws 3 metal finger to lift off the plastics button (plan view) Figure 1 Apparatus to determine forces to pull off plastics component Table 1 Dimensions of metal finger Dimensions in millimetres Nominal size of cap ISO 8362-6 ISO 8536-7 R b 13 8 8 20 12 10 28 16 12 32 20 15 The test re
25、sults shall be determined and recorded. For the cap to pass the test, the results shall conform to the requirements of the International Standard for the corresponding size. 4.2.3 Determination of force required to remove tab The cap is placed on a mandrel of dimensions as given in Table 2. As shown
26、 in Figure 2, a hook is placed in the tear-out ring exposed or in the plastics disc (which shall be perforated). The hook is then moved by the traction/pressure machine (4.2.1.1) in the direction shown until the aluminium cap has been opened completely. DIN ISO 10985:2009-12 6Key 1 direction of trac
27、tion 2 mandrel Figure 2 Apparatus to determine tear-off force Table 2 Dimensions of mandrel Dimensions in millimetres Nominal size of cap ISO 8362-6 ISO 8536-7 d1R 13 13,1 0,8 20 20,1 0,8 28 27,9 1,15 32 32,4 1,15 The test results shall be determined and recorded. For the cap to pass the test, the r
28、esults shall conform to the requirements of the International Standard for the corresponding size cap. 5 Sterilization and coating Sterilization and coating shall be carried out in accordance with Clause 5 of ISO 8872:2003. 6 Packaging Packaging shall comply with the requirements given in ISO 8872. 7 Marking Marking shall be in accordance with ISO 8872. DIN ISO 10985:2009-12 7
