1、 14534 2013II1 - 7 296 , 4 2 3 - 7 2013 . 72-4 14534:2011- . . (ISO 14534:2011 Ophthalmic optics Contact lenses and contact lens care products Fundamental require-ments). - , 5 1.0 2012 ( 8). - ( 1 ) , - . ( ) - . , (gost.ru) , 2014 , - - 14534 2013III () - ( ). - . - . - , , - . () . , /, 2. . - ,
2、 -. 75 % -. - - . CEN /CEN . 14534:1997. , . , , . 14534 2013IV 14534 20132care products Microbiological requirements and test methods for products and regimens for hygienic man-agement of contact lenses Amendment 1) 14730 . . (ISO 14730, Ophthalmic optics. Contact lens care products. Antimicrobial
3、 preservative ef cacy testing and guidance on determining discard date) 14971 . (ISO 14971, Medical devices Application of risk management to medical devices) 15223-1 . , . 1. (ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1
4、 General requirements) 18369-1 . . 1. , - (ISO 18369-1, Ophthalmic optics Contact lenses Part 1: Vocabulary, classi cation system and recommendations for labelling speci- cations) 18369-2 . . 2. (ISO 18369-2, Ophthalmic optics Contact lenses Part 2: Tolerances) 22442 ( ) (ISO 22442 (all parts), Med
5、ical devices utilizing animal tissues and their derivatives)3 18369-1.4 4.1 , - .4.2 - , - . , :a) , ;b) 18369-2;c) , , , - (. 10).d) , , , - , , - 10993-1;e) (. 8);f) - ( - ) , 11986;g) , (. 12);h) , , - ; . 2 .4.3 - . - , . 14534 201335 5.1 , . - . , - . 14971.5.2 :a) ;b) , ;c) , ;d) , , .6 , , - .7 7.1 , , , , , , , , .7.2 22442 ( ).7.3 .8 / :a) , - ;b) , ;c) . - , 14155 11980.9 . , - . - , , - , , . . .10 10.1 10.1.1 , . () 10-6. 14534 20134, , . - ., , , - , , . , , 54 -.10.1.2 , , , , - 100 ( ) . , - , 35.10.1.3 - . 6.10.2 10.2.1 , (- 250 ), ,
