GOST 31579-2012 Ophthalmic implants Ophthalmic viscosurgical devices General safety requirements《眼科植入物 黏弹性眼科植入装置 通用安全性要求》.pdf

1、 (ISO 15798:2001, MOD) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)315792012(ISO 15798:2001), 1.092 . 1.22009 . , - . , , -, 1 - ()2 (-)3 , (- 24 2012 . 41) : ( 3166) 00497 ( 3166) 00497 AZBYKZKGRUTJUZ 4 1 2012 . 644- 315792012 (ISO 15798:2001) 1 2015 .5 ISO 15798:200

2、1Ophthalmic implants Ophthalmic viscosurgical devices ( . - ) . . , , / . (MOD). 530782008 ( 15798:2001)6 , - . () - . , - , 2014 -, II 315792012 Ophthalmic implants. Ophthalmic viscosurgical devices. General safety requirements 201501011 (- ) , . , . . , , , , - , .2 : ISO 10993-12011 . -. 1. ISO 1

3、0993-52011 . -. 5. : in vitro ISO 10993-62011 . -. 6. ISO 10993-72011 . -. 7. ISO 10993-92011 . -. 9. - ISO 10993-102011 . -. 10. ISO 10993-122011 . . 12. ISO 10993-162011 . -. 16. ISO 134852011 . . - 146302002 . ISO 149712011 . -1 315792012(ISO 15798:2001) 312142003 . , , - , 315082012 . . 31580.72

4、012 (ISO 11979-7:2001) . -. 7. - - - , 1 , - . (), (-) . , , , , .3 - , , - , :3.1 (reference circle): 10 25 , .3.2 (viscoelastic): , .3.3 (equivalent area diameter): , - .3.4 (storage container): , - .3.5 (control populations): , - .3.6 (clinical investigator): / , () () - .3.7 (clinical investigat

5、ion): - / - .3.8 (monitor): , .3.9 (zero shear viscosity): - , .3.10 (sponsor): / , / .3.11 (final report): , , , .3.12 ; (ophthalmic viscosurgical device): , .3.13 (primary container): , () - . .3.14 ; (clinical investigation plan): , , , , - .3.15 ; : .2 3157920123.16 (rheologically active compone

6、nt): - , () .3.17 (shear viscosity): .1 .2 - ( c215). ().3.18 (adverse devise effect): , - . 31580.7, - .1 .2 ( ).3.19 (delivery system): , - .3.20 (sterile barrier): , - , .3.21 (subject): , / .3.22 (elasticity): . (, ) ( ).4 4.1 4.1.1 - 14630. :) ;b) ;c) .4.2 4.2.1 4.2.1.1 - 14630.4.2.1.2 , , , . , / .4.2.1.3 - 1.4.2.2 4.2.2.1 , - . , , . . , - , 2, 3 4.3 315792012 , , , - , . - . (-, , ). , - (25 c177 2) C.4.2.2.2 . - , - .4.2.2.3 -, ., - . - . , , .4.2.3 4.2.3.1 , , -