GOST R 55040-2012 Ophthalmic optics Contact lens care products Antimicrobial preservative efficacy testing and guidance on determining discard date《眼科光学 隐形眼镜护理产品 抗菌防腐剂效果试验和作废日期测定指南.pdf

1、 55040 2012 ISO 14730:2000 ISO 14730:2000 Ophthalmic optics Contact lens care products Antimicrobial preservative efficacy testing and guidance on determining discard date (MOD) 550402012 II 1 - 7 296 , 4 2 3 01 2012 . 687- 4 14730:2000 . . (ISO 14730:2000 Ophthalmic optics Contact lens care product

2、s Antimicrobial preservative efficacy testing and guidance on determining discard date) : - , 1.5 ( 4.2 4.3); - . , , . . , 5 1.02012 ( 8). ( 1 ) , . () . , (gost.ru) , 2014 , 550402012 III . , , , , , . , . , , (RGP) (MMA) , , RGP MMA, . . . , , , . . . , . , . . / , . - . . , 28 . , , 28 . 5504020

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4、0402012 2 3 53941. 4 4.1 , 14 . . . . 4.2 , , , . . 4.3 , . 5.6. 4.4 , . 5 5.1 5.1.1 - (-) -, 1. - , F. 1 - (Pseudomonas aeruginosa) ATCC 9027 (Staphylococcus aureus) ATCC 6538 (Escherichia coli) ATCC 8739 (Candida albicans) ATCC 10231 (Aspergillus niger) ATCC 16404 5.1.2 5.1.2.1 (TSA). 5.1.2.2 (SDA

5、). 5.1.2.3 - Dulbecco , (DPBS): 200 / KCl, 200 / KH2PO4, 8000 / NaCl 2160 / Na2HPO47H2O . 5.1.2.4 - Dulbecco 0,05 % (/) 80 (DPBST) . 5.1.2.5 ( ), , Dey-Engley (DEB) Letheen. 5.1.3 : . . . ( 90 100 20 ). 550402012 3 . ( ). . 5.2 - , , , . . () . - . - . - (ATCC, NCIB, NCTC, NCPF ) - (. F), - . 5.3 () , 2. 2 , C P. aeruginosa TSA 30 35 18 24 S. aureus TSA 30 35 18 24 E. coli TSA 30 35 18 24 C. albicans SDA 30 35 18 24 A. niger SDA 20 25 7 10 DPBST ; , . , . . (, 3 5 ). - 1107 1108 / DPBST . . ( /) , . , 20 25 10 4000 g. . 1 . 2 7 2 8 . 5.4 - 5.4.1 ( ), 10 -. , , .