KS P ISO 9394-2006 Ophthalmic optics－Contact lenses and contact lens care products－ Determination of biocompatibility by ocular study with rabbit eyes《眼科光学 接触镜和接触镜保护产品 用兔眼视觉研究法测定生物.pdf

1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS 2006 12 5 http:/www.kats.go.krKS P ISO 9394 KS P ISO 9394： 2006 (2011 )P ISO 9394： 2006 : ( ) ( ) ( ) : (http:/www.standard.go.kr) ： ：2006 12 5 ：2011 12 30 2011-0664 ： ： ( 02-509-7274) (http:/www.kats.go.kr). 10 5 , . ICS 11.040.70 KS P ISO 9394： 2006(2011

2、) Ophthalmic optics Contact lenses and contact lens care products Determination of biocompatibility by ocular study with rabbit eyes 1998 2 ISO 9394 Ophthalmic optics Contact lenses and contact lens care products Determination of biocompatibility by ocular study with rabbit eyes . 1. . . . 2. . . KS

3、 P ISO 8321 1 , 1： KS P ISO 8321 2 , 2： KS P ISO 10993 1 1： KS P ISO 10993 10 10： ISO 10993 2 Biological evaluation of medical devices Part 2： Animal welfare requirements ISO/IEC Guide 25 General requirements for the competence of calibration and testing laboratories 3. KS P ISO 10993 1 . ISO/IEC Gu

4、ide 25 . KS P ISO 10993 10 . . 4. 4.1 ( , , ) . 2.5 kg . . 3 , 6 . 6 . . P ISO 9394： 2006 2 . . “ ” . 4.2 ISO 10993 2 . 4.3 . . 4.4 . a) b) c) d) 5 . 4.5 ( ) . 1. . 2. 2 . . . 4.6 . 5. / 5.1 , ( 1 % 3 L). 5.2 , 5.3 , 6. 6.1 , 6.2 . 6 6.3 . 5 kg 100 g 7. 7.1 a) b) . . . . KS P ISO 8321 1 KS P ISO 832

5、1 2 . 7.2 P ISO 9394： 2006 3 (5.2). (5.2). 1. . 2. . . . . . . , . 8. 8.1 8.1.1 24 . 8.1.2 (6.3). 8.1.3 (6.1) (5.1) McDonald Shadduck ( A ). . 8.2 8.2.1 7.2 . 8.2.2 . . , . . . 8.2.3 1 21 78 . 7.2 . 1 . 8.2.4 . , . 8.2.5 . 8.2.6 8.2.18.2.5 . 8.2.7 22 48 . . 8.3 8.3.1 17, 914, 1621 Draize ( B ) . . P

6、 ISO 9394： 2006 4 . . 8.3.2 8, 15, 22 (6.1) (5.1) McDonald Shadduck ( A ). 8.4 22 (6.3) . 8.5 8.5.1 22 . 8.5.2 ( 10 % , Zenker Davidson ). 8.5.3 . 8.5.4 , , . . 8.5.5 . 8.6 , . 2 . 9. ISO/IEC Guide 25 (GLP) . 10. 10.1 . 10.2 . 10.3 . P ISO 9394： 2006 5 A() McDonaldShadduck A.1 0 = . / 12 6 , . 1 = 4

7、7 111 . 2 = 75 % 3 = / . A.2 0 = . 1 = ( ). . 2 = . . . . 3 = / . . . 4 = / . . A.3 , . 0 = . . 1 = . . 2 = . 3 = . A.4 . . 0 = ( ). 1 = . . 2 = . 3 = . P ISO 9394： 2006 6 A.5 1 , 2 , 3 . 2 3 . 0 = . 12 1 6 7 13 mm 2 3 . 1 = 2 (3 ). 1 6 . 1 6 3 . 2 = 3 2 3 = 2 3 ( 3 9 .) 4 = 2 3 . . A.6 . . 0 = . .

8、1 = . 1/2 . , . 2 = . (前部 ) . . . 3 = . . ( ). 4 = . . . , , . 0 4 5 . 0 = . 1 = 125 % 2 = 2650 % 3 = 5175 % 4 = 76100 % . . 3 . 0 = . 1 = . 2 mm . 2 = 2 mm P ISO 9394： 2006 7 . 0 4 . 0 = . 1 = . ( ). 2 = . . 3 = . . . 4 = . . N( ) A( ) . . P ISO 9394： 2006 8 B() Draize B.1 (A) ( ) . 0 , . 1 , . 2 ,

9、 . 3 . 4 (B) 0 1/4 1 1/4 1/2 . 2 1/2 3/4 . 3 3/4 , . 4 = AB5 . = 80 B.2 (A) 0 , , , ( ), ( ) . 1 , , ( ) . 2 = A5 = 10 B.3 (A) ( ) . 0 1 2 . 3 (B) . 0 ( ) . 1 . 2 . 3 . 4 (C) . 0 ( ) 1 P ISO 9394： 2006 9 2 , . 3 = (A + B + C )2 . = 20 B.4 , . 1 110 . P ISO 9394： 2006 10 C() 11 KS P ISO 9394： 2006 ,

10、. 1. 1.1 , . . 1.2 1998 2 ISO 9394 Ophthalmic optics Contact lenses and contact lens care products Determination of biocompatibility by ocular study with rabbit eyes , . 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 9394： 2006 Ophthalmic opticsContact lenses and contact lens care productsDetermination of biocompatibility by ocular study with rabbit eyesICS 11.040.70