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!$=“1562697ww
2、w.din.deDDIN ISO 8536-7Infusion equipment for medical use Part 7: Caps made of aluminium-plastics combinations for infusionbottles (ISO 8536-7:2009)English version of DIN ISO 8536-7:2009-12Infusionsgerte zur medizinischen Verwendung Teil 7: Brdelkappen aus Aluminium-Kunststoffkombinationen fr Infusi
3、onsflaschen(ISO 8536-7:2009)Englische Fassung DIN ISO 8536-7:2009-12SupersedesDIN ISO 8536-7:2001-07www.beuth.deDocument comprises pages8DIN ISO 8536-7:2009-12 2National foreword This standard has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medic
4、al and 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 elem
5、ents 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 2768-1 DIN ISO 2768-1 ISO 2768-2 DIN ISO 2768-2
6、ISO 8536-1 DIN EN ISO 8536-1 ISO 8872 DIN EN ISO 8872 ISO 10985 DIN ISO 10985 DIN (EN) ISO 8536 consists of the following parts, under the general title Infusion equipment for medical use: Part 1: Infusion glass bottles Part 2: Closures for infusion bottles Part 3: Aluminium caps for infusion bottle
7、s Part 4: Infusion sets for single use, gravity feed Part 5: Burette infusion sets for single use, gravity feed Part 6: Freeze drying closures for infusion bottles Part 7: Caps made of aluminium-plastics combinations for infusion bottles Part 8: Infusion equipment for use with pressure infusion appa
8、ratus Part 9: Fluid lines for use with pressure infusion equipment Part 10: Accessories for fluid lines for use with pressure infusion equipment Part 11: Infusion filters for use with pressure infusion equipment Part 12: Check valves Amendments This standard differs from DIN ISO 8536-7:2001-07 as fo
9、llows: a) Clause 2 “Normative references” has been updated. b) The content of the International Standard ISO 8536-7:2009 has been adopted in its entirety. Previous editions DIN ISO 8536-7: 1993-06, 2001-07 National Annex NA (informative) Bibliography DIN EN ISO 8536-1, Infusion equipment for medical
10、 use Part 1: Infusion glass bottles DIN EN ISO 8872, Aluminium caps for transfusion, infusion and injection bottles General requirements and test methods DIN ISO 2768-1, General tolerances Tolerances for linear and angular dimensions without individual tolerance indications DIN ISO 2768-2, General t
11、olerances Geometrical tolerances for features without individual tolerances indications DIN ISO 10985, Caps made of aluminium-plastics combinations for infusion bottles and injection vials Requirements and test methods DIN ISO 8536-7:2009-12 3 This page is intentionally blank DIN ISO 8536-7:2009-12
12、4Infusion equipment for medical use Part 7: Caps made of aluminium-plastics combinations for infusion bottles Introduction The materials from which infusion glass bottles (including elastomeric closures) are made are suitable primary packaging materials for storing infusion solutions until they are
13、administered. However, in this part of ISO 8536, caps of aluminium-plastics combinations are not considered as primary packaging materials in direct contact with the infusion solution. DIN ISO 8536-7:2009-12 51 Scope This part of ISO 8536 specifies caps made of aluminium-plastics combinations intend
14、ed for use on infusion glass bottles which are in accordance with ISO 8536-1. 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 refe
15、renced 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 without individual tolerance indications ISO 853
16、6-1, Infusion equipment for medical use Part 1: Infusion glass bottles ISO 8536-3, Infusion equipment for medical use Part 3: Aluminium caps for infusion bottles ISO 8872:2003, Aluminium caps for transfusion, infusion and injection bottles General requirements and test methods ISO 10985, Caps made o
17、f aluminium-plastics combinations for infusion bottles and injection vials Requirements and test methods 3 Classification of type 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 co
18、mponent. DIN ISO 8536-7:2009-12 64 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 shape of the cap shown in Figure 1 is an example only. 4.2 Tolerances Cap tolerances shall be in acco
19、rdance with ISO 2768-1 and ISO 2768-2. Dimensions in millimetres a) Type ZB b) Type ZD Key 1 plastics component 2 aluminium cap 3 score line Figure 1 Configuration of cap Table 1 Dimensions of cap Dimensions in millimetres d1d2ad3bech1h2dNominal size 0,10,05+min. max. min. max. min. max. 0,25 min. m
20、ax. 28 28,1 30,5 31,5 12 17 0,168 0,242 8,6 to 9,0 9 12 32 32,6 35,5 37 15 20 11,9 13 16 aThe diameter, d2, shall be agreed upon between the manufacturer and the user. It shall not differ from the nominal value by more than 0,25 mm. The extreme limits are given without tolerance. bAfter plastics ele
21、ment removal. cThe thickness, e, shall be agreed upon between the manufacturer and the user. It shall not differ from the nominal value by more than 0,022 mm. The extreme limits are given without tolerance. dThe height, h2, shall be agreed upon between the manufacturer and the user. It shall not dif
22、fer from the nominal value by more than 0,4 mm. The extreme limits are given without tolerance. DIN ISO 8536-7:2009-12 75 Designation Aluminium-plastics caps shall be designated according to type. The designation is expressed as the word “Cap”, followed by the number and part of this International S
23、tandard, followed by the type letters, followed by the nominal size of the cap. EXAMPLE A type ZD aluminium-plastics cap of nominal size 32 complying with the requirements of this part of ISO 8536 is designated as follows: Cap ISO 8536-7 - ZD - 32 6 Requirements 6.1 General requirements 6.1.1 The re
24、quirements for aluminium caps shall be in accordance with ISO 8536-3. 6.1.2 The requirements for plastics components and for the combination between the plastics component and the aluminium cap shall be in accordance with ISO 10985. 6.1.3 Construction elements which penetrate into the interior space
25、 of the aluminium cap shall not interfere with the sealing process. 6.2 Force required to remove tab 6.2.1 The maximum force required to remove the tab shall comply with Table 2. Table 2 Force required to remove plastics component and tear-off tab completely Force in newtons Nominal size Force to re
26、move plastics component max. Force to tear off tab completely max. 28 32 40 60 30 40 6.2.2 For incoming control, a minimum value for the tear-off tab removal force shall be agreed between the supplier and the user. The infusion caps shall also withstand a sterilization process in accordance with 5.1 of ISO 8872:2003. 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 ISO 8536-7:2009-12 8
