GOST 31580 5-2012 Ophthalmic implants Intraocular lenses Part 5 Biocompatibility《眼科植入物 人工晶体 第5部分 生物适合性》.pdf

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1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) 5 (ISO 11979-5:2006, MOD) 2013 31580. 5 2012 (ISO 11979-5:2006) 31580.52012 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 41-2012 24 2012 .) : ( 3166) 00497 ( 3166) 00497 AZ BY KZ KG MD - RU TJ UZ 4 01 2012 . 647- 3

2、1580.52012 (ISO 11979-5:2006) 1 2015 . 5 ISO 11979-5:2006 Ophthalmic implants Intraocular lenses Part 5: Biocompatibility ( . . 5. 31580.52012 III ) . , , / (MOD) 528582007 ( 11979-5:2006) 6 ( ) . , . C, 2013 , 31580.52012 (ISO 11979-5:2006) 1 5 Ophthalmic implants. Intraocular lenses. Part 5. Bioco

3、mpatibility 2015-01-01 1 ( ) , , ( , ). , - . 2 : ISO 10993-12011 . . 1. ISO 10993-32011 . . 3. , ISO 10993-52011 . . 5. : 31580.52012 2 in vitro ISO 10993-62011 . . 6. ISO 10993-102011 . . 10. ISO 10993-122011 . . 12. ISO 149712011 . 31580.22012 (ISO 11979-2:1999) . . 2. 31580.32012 (ISO 11979-3:19

4、99) . . 3. , 1 , , . (), , () . , , , , . 3 , 3.1 , , : 3.1.1 (material degradation test): , . 3.1.2 (solvent): (, , ), 31580.52012 3 , , , . 3.1.3 (reference solution): , , , , . 3.2 : Nd-YAG - , ; In vivo ; In vitro ; - ; ; ; / -; . 4 4.1 ISO 14971, : 1) - 5; 2) ISO 10993-1 1, - 5. 4.2 , , , . 4.3

5、 ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10 56 . 4.4 4.14.3 31580.52012 4 / ISO 14971. 5 - 5.1 5.1.1 - : a) ; b) ; c) ; d) ( -/ ); e) Nd-YAG ; f) . 5.1.2 5.1.1 : ) , ; b) ; c) ; d) , , , / . : , , , , . 5.1.3 5.1.1 ISO 14971. - 5.1.1 , , . 5.2 5.2.1 . , , . 31580.52012 5 . 5.2.2 : a) , , ;

6、b) . , , , . / ; c) . . 5.2.3 . 5.3 5.3.1 . , , . 5.3.2 5.2.2 5.2.3. 5.4 5.4.1 . 5.4.2 : a) (35 2) ; b) F, 31580.52012 6 , ; 0 , 35 ; c) ; d) : - 10 ; - 500 . , . , , ; e) . , . . . ( 0,25 20 ). 5.4.3 - . 5.5 5.5.1 . 5.5.2 - , , -, - . 5.5.3 , - , , 31580.52012 7 , . 1 , , 31580.3. 2 , - : a) - in vivo 300 400 l1= 0,3 /2. 1 /2= 100 /2 , . 300 400 6,5 % , . 6,5 /2. , . , -, ,

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