GOST 31585-2012 Ophthalmic Implants Irrigating solutions for ophthalmic surgery General safety requirements《眼科植入物 眼科手术用冲洗方法 通用安全性要求》.pdf

1、 I , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) (ISO 16671:2003, MOD) 2013 31585 2012 (ISO 16671:2003) 315852012 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 . 650- 31585201

2、2 (ISO 16671:2003) 1 2015 . 5 ISO 16671 : 2003 Ophthalmic implants Irrigating solutions for ophthalmic surgery ( . ) . 315852012 III . . , , / . (MOD). 534682009 (ISO 16671 2003) 6 ( ) . , . C, 2013 , 315852012 (ISO 16671:2003) 1 Ophthalmic Implants. Irrigating solutions for ophthalmic surgery. Gene

3、ral safety requirements 2015-01-01 1 ( ) , . , . , , , , , . 2 : ISO 10993-12011 . . 1. ISO 10993-52011 . . 5. : in vitro ISO 10993-62011 . . 6. 315852012 2 ISO 10993-72011 . . 7. ISO 10993-102011 . . 10. ISO 10993-122011 . . 12. 146302002* . ISO 149712011 . 312142003 . , , - , 315082012 . . 31580.7

4、2012 (ISO 11979-7:2001) . . 7. , 1 , , . (), , () . , , , , . 3 , , _ * 146302011 . 315852012 3 , *: 3.1 (reference circle): 10 25 , . 3.2 (equivalent area diameter): , . 3.3 (sensor dynamic range): , . 3.4 (storage container): , , . 3.5 (control populations): , . 3.6 (clinical investigator): / , .

5、3.7 (clinical investigation): / . 3.8 (final report): , , , . 3.9 , (ophthalmic irrigating solution): , . 3.10 , (clinical investigation plan): , , , , , . 3.11 , (graticule field of view): , . _ * 518922002 ( 11979-1:99) . . 1. 315852012 4 3.12 (adverse device effect): , . .1 .2 31580.7. 3.13 (deli

6、very system): , . 3.14 (sterile barrier): , , . 3.15 (subject): , / . 3.16 (volumetry): , , () ( ). 4 4.1 4.1.1 . , 14630. 4.1.2 , , , . 4.2 4.2.1 4.2.1.1 14630. 4.2.2 4.2.2.1 , . 315852012 54.2.2.2 , - . , , . 4.2.3 4.2.3.1 1, 2. 4.2.4 4.2.4.1 , . , . 4.2.4.2 pH - (25 2) . . pH pH (pH 7,38) . in vitro , pH, , . , . 1. 1 pH , / , / 0,0005 0,004 6,5 8,5 0,0005 0,005 0,004 0,04 6,7 8,2 0,005 0,04 7,2 7,6 4.2.4.3 315852012 6 . , . , , , . , , , , , . , , . . . 4.2.4.4 . 200 400 /. . 4.2.4.5 300 1100 . : , %, , . 4.2.4.6 , , .