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1、INTERNATIONAL STANDARD 8362-6 First edi tioh 1992-10-01 - Injection containers for injectables and accessories - Part 6: Caps made of aluminium-plastics combinations for injection vials Rkcipients et accessoires pour prodrlits injectables - Par-tie 6: Capsules en combinaison aluminium-plastique pour
2、 flacons - Type ZD: Aluminium cap with complete tear-off tab, and plastics component. 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 1 The configuration of the cap shown in figure 1 is
3、informative only. 4.2 Tolerances The tolerances shall be in accordance with IS0 2768-l and IS0 2768-2. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/26/2007 03:38:36 MDTNo reproduction
4、 or networking permitted without license from IHS -,-,- IS0 8362=6:1992(E) . Type ZB 1 Plastics component Dimensions in millimetres Type 20 2 Aluminlum cap In accordance with IS0 8362-3 3 Score llne Figure 1 - Configuration of cap Table 1 - Dimensions of cap Dimensions in millimetres Nominal size 4
5、-I-O,1 0 dz ) d3 2) c! 3) h, h, 4) min. max. min. max. min. max. * 02 min. max. 13 13,3 15 16 3 8 693 793 894 1 0,168 0,242 20 20,3 22,2 23,2 6 10 793 877 94 1) The diameter d2 shall be agreed between the manufacturer and user. It shall not differ from the nominal value by more than + 0,25 mm. The e
6、xtreme limits are given without tolerance. 2) After plastics element removal. 3) The 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 tolerance. 4) The height h, shall be agreed bet
7、ween the manufacturer and user. It shall not differ from the nominal value by more than Ifr 0,3 mm. The extreme limits are given without tolerance. 5 Designation 6 Requirements Aluminium-plastics caps shall be designated ac- cording to type: the designation shall be expressed as the word “cap”, the
8、number and part of this International Standard followed by the type letters, followed by the nominal size of the ccntainer. For example a type ZD aluminium-plastics cap of nominal size 13 complying with the requirements laid down in this part of IS0 8362 is designated: Cap IS0 8362-6 - ZD - 13 6.1 G
9、eneral requirements 6.1.1 The requirements for aluminium caps shall be in accordance with IS0 8362-3. 6.1.2 The requirements for plastics components, and the combination between the plastics compo- nent and the aluminium cap, shall be in accordance with IS0 10985. 6.1.3 Construction elements which p
10、enetrate into the interior space of the aluminium cap shall not in- terfere with the sealing process. 2 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/26/2007 03:38:36 MDTNo reproductio
11、n or networking permitted without license from IHS -,-,- IS0 8362=6:1992(E) 6.2 Forces required to remove tab 6.2.1 The maximum forces required to remove the tab shall comply with table 2. Table 2 - Forces required to remove plastics component and tear off tab completely Forces in newtons I I I I /
12、Nominal size 1 F”&e / :o,b”“cZL 1 max. max. 25 30 35 40 6.2.2 For incoming control, a minimum value for the tear-off tab removal force shall be agreed be- tween the supplier and user. The injection caps shall also withstand a sterilization process in accordance with IS0 8872:1988, subclauses 5.1 and
13、 5.2 b). 7 Packaging Packaging shall comply with the requirements of IS0 8872. 8 Marking Marking shall be in accordance with IS0 8872 and the designation shall be as specified in clause 5. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA T
14、echnical Standards 1/9972545001 Not for Resale, 04/26/2007 03:38:36 MDTNo reproduction or networking permitted without license from IHS -,-,- IS0 *8362=6:1992(E) - -a-v- - UDC 615.473:615.456.014.87-034+036 Descriptors: medical equipment, parenteral infusion equipment, containers, bottles, aluminium
15、 products, plastics products, caps (containers), classification, specifications, dimensions, designation, marking, packaging. Price based on 3 pages 1 -,=-p,- -.- - _-_- - l Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/26/2007 03:38:36 MDTNo reproduction or networking permitted without license from IHS -,-,-