KS P ISO 11980-2006 Ophthalmic optics－Contact lenses and contact lens care products－Guidance for clinical investigations 《眼科光学 隐形眼镜和隐形眼镜防护产品 临床检测指南》.pdf

1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS 2006 12 5 http:/www.kats.go.krKS P ISO 11980 KS P ISO 11980： 2006 (2011 )P ISO 11980： 2006 : ( ) ( ) ( ) : (http:/www.standard.go.kr) ： ：2006 12 5 ：2011 12 30 2011-0715 ： ： ( 02-509-7274) (http:/www.kats.go.kr). 10 5 , . ICS 11.040.70 KS P ISO 11980： 2006(2

2、011 ) Ophthalmic optics Contact lenses and contact lens care products Guidance for clinical investigations 1997 1 ISO 11980 Ophthalmic optics Contact lenses and contact lens care products Guidance for clinical investigations . 1. . 2. . . KS B ISO 14534 ISO 14155 Clinical investigation of medical de

3、vices . . . D . 3. ISO 14155 KS B ISO 14534 . ISO 8320 1 KS B ISO 8320 2 ( D ). 4. ISO 14155 . , (ISO 14155). . . ( , ) P ISO 11980： 2006 2 . 5. 5.1 , , , ISO 14155 . 5.2 . . 1. . . 2. , , . , ( D ). 5.3 . 5.4 . A B . 6. . , , . , , , . . a) , , . . b) c) d) e) f) C P ISO 11980： 2006 3 A() , A.1 . A

4、.2 A.2.1 . A.2.2 . 0 = . 1 = 120 2 = 2150 3 = 51100 4 = 100 . 4 . A.2.3 . 0 = . 1 = 2 = (CCC) . 3 = (CCC) 4 = (CCC) A.3 . 0 = . 1 = 15 2 = 68 3 = 8 4 = A.4 . 0 = 1 = 2 = 3 = 4 = A.5 . 0 = . 1 = 1.00 mm P ISO 11980： 2006 4 2 = 1.00 mm 1.5 mm 3 = 1.5 mm 2.00 mm 4 = 2.0 mm . ： a) b) ： N T I S C X ( ) A

5、.6 ( 1. 2. ). 0 = . 1 = a) b) 2 = a) b) 3 9 c) 3 = 2 mm a) b) 4 = 2 mm . ( A.1 ). 1. . 2. “ ” . A.1 A.7 . 0 = . 1 = ( ) 1 C 2 S 3 N 4 I 5 T P ISO 11980： 2006 5 2 = ( ) 3 = ( ) 4 = ( ) . 0 = . 1 = 2 = 3 = 4 = / (0 = , 1 = ). A.8 . 0 = 1 = 2 = 1 mm / 3 = a) 1 mm / b) 4 = a) 1 mm / b) 1 4 . 1 = 2 = 3 =

6、 ( ) 4 = P ISO 11980： 2006 6 B() , , B.1 . B.2 . , , . , . LogMAR . LogMAR . LogMAR . B.3 ( ) . B.4 . B.5 B.5.1 . B.5.2 ( ) 3 . 0 = 1 = 2 = B.5.3 . a) b) 2 = 1 = 0 = 1 = 2 = B.6 B.6.1 0 = 1 = 2 = ( ). 3 = P ISO 11980： 2006 7 B.6.2 0 = , 1 = , . 2 = , , 3 = , 4 = , . B.6.3 0 = , 1 = , 3 2 = , 10 3 =

7、, 3 4 = , 4 B.7 B.7.1 0 = , . 1 = , . 2 = , . 3 = , . 4 = , . 5 = , . B.7.2 0 = , . 1 = , 2 = , 3 = , 4 = , , 5 = , . B.7.3 0 = , 1 = , 2 = . 3 = , . 4 = , . 5 = , . B.7.4 ( C.6 ) P ISO 11980： 2006 8 C() C.1 C.2 C.3 C.4 (ADE) C.5 ( ) C.6 , , ( ) C.7 () C.8 C.9 C.10 C.11 , C.12 C.1 (C) (T) C T ( ) C

8、C T C T (n ) C T T C C T P ISO 11980： 2006 9 C.2 ： ： ： ： ： ： ： ( ) D D D C.3 1 2 3 4 ： C.4 (ADE) 1 2 3 4 ： P ISO 11980： 2006 10 C.5 ( ) %1 % 2 % 3 % 4 % % % 0 = , 1 = , 120 2 = , 2150 3 = , 51100 4 = , 100 C.6 , , ( ) % 1 % 2 % 3 % 4 % % % 0 = , 1 = , 2 = , 3 = , 4 = , 5 = , C.7 () % % % 0.001.00 D(

9、1) 1.121.50 D(11.622.00 D(1) ( ) D D D 1 D , ( ) H/V 1 2 3 (1) 1.00 D 0.20 mm . P ISO 11980： 2006 11 C.8 0.001.00 D 1.121.50 D 1.622.00 D ( ) D D D 1 D ( ) 1 2 3 C.9 20/15 % 20/20 % 20/25 % 20/30 % 20/40 % % % 20/15 20/20 20/25 20/30 20/40 = 100 ： 20/30 ： 20/30 1 LogMAR ( ) 1 LogMAR ： LogMAR 1 2 3 P

10、 ISO 11980： 2006 12 C.10 1 % 2 % 3 % 4 % % % 0.04.0 4.16.0 6.18.0 8.110.0 10.112.0 12.114.0 14.116.0 16.118.0 18.1 / ( ) C.11 , 1 2 3 4 C/T C/T C/T C/T C/T C/T C/T % C/T C/T C/T C/T C/T C/T C/T % % =100 P ISO 11980： 2006 13 C.12 % 1 % 2 % 3 % 4 % % % C/T C/T C/T C/T C/T C/T C/T C/T C/T C/T C/T C/T C

11、/T C/T C = T = ： . ： . ( 12A ) ( 12B ) , . . . = 100 P ISO 11980： 2006 14 D() KS B ISO 8320： 2002 ISO 8320 1 Contact lenses and contact lens care products Vocabulary Part 1： Contact lenses KS B ISO 8320 2： 2004 2： KS A 9001： 2001 15 KS P ISO 11980： 2006 , . 1. 1.1 , . . 1.2 1997 1 ISO 11980 Ophthalm

12、ic optics Contact lenses and contact lens care products Guidance for clinical investigations . 2. . 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KSKSKSSKSKS KSKS SKS KSKS SKSKS KSKSKSKorean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 11980： 2006 Ophthalmic opticsContact lensesand contact lens care productsGuidance for clinical investigationsICS 11.040.70