1、 , () EURO-ASIAN COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) 7 (ISO 11979-7:2001, MOD) 2013 31580. 7 2012 (ISO 11979-7:2001) 31580.72012 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 41-2012 24 2012 .) : ( 3166) 00497 ( 3166) 00497 AZ BY KZ KG RU TJ UZ 4 01 2012 . 649- 31580-
2、72012 (ISO 11979-7:2001) 1 2015 . 5 ISO 11979-7:2001 Ophthalmic implants Intraocular lenses Part 7: Clinical investigations ( . . 7. 31580.72012 III ) ( ). . , , / , , . ISO 14155-1:2003 Clinical investigation of medical device for human subjects Part 1: General requirements ( 14155-1:2003 . 1. ) ,
3、, . (MOD). 524582005 ( 11979-7:2001) 6 ( ) . , . C, 2013 , 31580.72012 (ISO 11979-7:2001) 1 7 Ophthalmic implants. Intraocular lenses. Part 7. Clinical investigations 2015-01-01 1 ( ) , , ( , ). , . 1. 2 : 31580.22012 (ISO 11979-2:1999) . . 2. 31580.32012 (ISO 11979-3:1999) . . 3. 31580.62012 (ISO 1
4、1979-6:1999) . . 6. 31580.72012 2 , 1 , , . (), , () . , , , , . 3 3.1 , , , 31580.3 : 3.1.1 (adverse device effect): , . .1 .2 A. 3.1.2 ; (clinical investigation plan): , , , , , . 3.1.3 (clinical investigation): / . 3.1.4 (subject): , / . 3.1.5 (clinical investigator): / , . / . 3.1.6 (sponsor): /
5、 , / . 3.1.7 (principal clinical investigator): 31580.72012 3 , , (). 3.1.8 (coordinating clinical investigator): , , (). 3.1.9 (clinical performance): / , . 3.1.10 (case report form): , , . 3.1.11 (clinical investigators brochure): , , . 3.1.12 (monitor): , . 3.1.13 (source documents): , , , / , .
6、3.1.14 (final report): , , . 3.1.15 (ethics committee): , , , . 3.1.16 (informed consent): , , . B. 3.1.17 (control populations): , 31580.72012 4 , 31580.2 31580.6. 3.1.18 (historical control population): , . 4 4.1 4.1.1 , , , . 4.1.2 , , - , . 4.1.3 , . , , . 4.1.4 . 5 5.1 5.1.1 , , , , . . 5.1.2 ,
7、 , / / 31580.72012 5 . 5.1.3 2. 5.1.4 , . . 5.1.5 . , , . 5.1.6 . 5.1.7 , , . 5.1.8 : - ; - ; - . 5.2 5.2.1 . 5.2.2 : - , ; - , , , . C. 5.2.3 , 31580.72012 6 , D. . , . 5.2.4 . , , , , , . 6 6.1 6.1.1 6.1.3 . . 6.1.2 : ) , . ; ) ; ) , , , . , , . .; ) ; ) , ; 31580.72012 7) in vitro / in vivo, , , , ; ) ; ) ,
