1、 KSKSKSKS SKSKSKS KSKSKS SKSKS KSKS SKS KS 2005 12 30 KS B ISO 11978 KS B ISO 11978: 2005 (2010 )B ISO 11978: 2005 ( ) ( ) ( ) ( ) : : 2005 12 30 : 2010 5 10 2010 0157 : : ( ) ( 02 509 728790) . 7 5 , . ICS 11.040.70 KS B ISO 11978: 2005Ophthalmic optics Contact lenses and contact lens care products
2、 Information supplied by the manufacturer 2000 1 ISO 11978 Ophthalmic optics Contact lenses and contact lens care products Information supplied by the manufacturer . 1. : 2. . . KS B ISO 8320 2 2: ISO 8320 1 Contact lenses and contact lens care products Vocabulary Part 1: Contact lenses 3. ISO 8320
3、1 KS B ISO 8320 2 . 3.1 ISO 14534( ). 3.2 3 , , , . 3.3 4. 4.1 , . , , . , . (4.2 4.3 ), . , , . ( ), , B ISO 11978: 2005 2 . 4.2 4.2.1 1 / 2 . 4.2.3 a) b) , 1) / 2) 3) 4) , ( , ) , 1 “ ” . c) , “ (sterile)” d) “ (lot)” (lot number) e) f) , “ “ g) , “ ( ) ” h) , “ ” i) , “: ” , / , , / . 4.2.2 2 4.2
4、.1 . a) “: ” / , , “ ” b) , , “ ”. c) / d) : “ ” e) , 2 “ ” . 4.2.3 , . a) b) c) 4.3 . / . a) b) , 1) / B ISO 11978: 2005 3 2) c) , ( ) d) e) , / f) g) h) , , i) j) k) , l) m) n) o) p) , q) , “ “ r) , “ ( ) ” s) , “ ” t) u) 5. 5.1 , . , , . , . (4.2 4.3 ), . , , . ( ), , . 5.2 5.2.1 1 / 2 . 15 mL 1
5、5.2.2 B ISO 11978: 2005 4 a) b) , 1) 2) ( , , , ) 3) c) , “ (sterile)” d) “ (lot)” (lot number) e) f) , “ ( ) ” g) , “ ” h) i) , “: ” “: ” 1 / 2 . “ ” . j) k) , l) , , “ .”, “ .” m) n) “ ” o) , p) “ .” q) , r) , “ ” ISO 14729(Ophthalmic optics Contact lens care products Microbiological requirements
6、and test methods for product and regimens for hygienic management of contact lenses) s) , t) , 5.2.2 15 mL 1 . a) b) c) “ (lot)” (lot number) d) e) , “ .” f) , “ ” g) “: ” “: ” 1 / 2 . “ ” . B ISO 11978: 2005 5 5.3 . a) b) , 1) 2) ( , , ) 3) c) , “ (sterile)” d) e) f) g) , , h) i) j) k) , l) 6 KS B
7、ISO 11978: 2005 , . 1. . 2. a) WTO , . b) ISO 11978 Ophthalmic optics Contact lenses and contact lens care products Information supplied by the manufacturer . 3. ISO 11978 Ophthalmic optics Contact lenses and contact lens care products Information supplied by the manufacturer . 2006 1 23 135 513 701
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