1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS 2006 12 5 http:/www.kats.go.krKS P ISO 16671 KS P ISO 16671： 2006 (2011 ) P ISO 16671： 2006 : ( ) ( ) ( ) : (http:/www.standard.go.kr) ： ：2006 12 5 ：2011 12 30 2011-0716 ： ： ( 02-509-7274) (http:/www.kats.go.kr). 10 5 , . ICS 11.040.70 KS P ISO 16671： 2006(
2、2011 ) Ophthalmic implantsIrrigating solutions for ophthalmic surgery 2003 1 ISO 16671 Ophthalmic implants Irrigating solutions for ophthalmic surgery . 1. , , , , , , . (OIS) . , , . 2. . . KS P ISO 10993 1 1 KS P ISO 11607 KS P ISO 14630 KS P ISO 14971 1 1： KS P ISO 15223 , ISO 10993 2 Biological
3、evaluation of medical devices Part 2： Animal welfare requirements ISO 13408 1 Aseptic processing of health care products Part 1： General requirements ISO 14155 1 Clinical investigation of medical devices for human subjects Part 1： General requirements ISO 14155 2 Clinical investigation of medical de
4、vices for human subjects Part 2： Clinical investigation plans EN 868 1 Packaging materials and systems for medical devices which are to be sterilized Part 1： General requirements and test methods EN 1041 Information supplied by the manufacturer with medical devices EN 12442 1 Animal tissues and thei
5、r derivatives utilized in the manufacture of medical devices Part 1： Analysis and management of risk 3. . 3.1 3.2 (Ophthalmic Irrigating Solution：OIS) , , . 4. . KS P ISO 14630 P ISO 16671： 2006 2 . , , , , . 5. 5.1 KS P ISO 14630 . 5.2 , . , . . 5.3 ( 3 ) . 5.4 5.4.1 OIS . . 5.4.2 (252) . (pH 7.38)
6、 . (In vitro) . . A . 1 . 1 (mol/L per pH) (mol/L per pH) 0.005 0.04 7.27.6 5.4.3 , . , . , . . . . , . 5.4.4 (osmolality) OIS . 200 mosm/kg 400 mosm/kg . . P ISO 16671： 2006 3 5.4.5 3001 100 nm . . 5.4.6 5.4.6.1 . OIS , . , . , , . 5.4.6.2 OIS . B . 5.4.6.3 C (LOT ) D , OIS . C LOT . OIS 1 mL 10 m
7、50 OIS 1 mL 25 m 5 OIS 1 mL 50 m 2 D . OIS 1 mL 10 m 25 OIS 1 mL 25 m 2.5 OIS 1 mL 50 m 1 C LOT . , . D , . LOT . 6. 6.1 OIS . KS P ISO 14630 . 6.2 6.2.1 OIS . KS P ISO 14971 1 . OIS . OIS EN 12442 1 . 1. . OIS KS P ISO 10993 1 . P ISO 16671： 2006 4 2. , OIS “ , / ” . ISO KS P 10993 1 1 , . 3. . , .
8、 KS P ISO 10993 1 , OIS . 6.2.2 USP 245 , LAL (Limulus Amebocyte Lysate) OIS . 0.5 EU( ) . 6.2.3 , , , , E . . ISO 10993 2 . . , OIS OIS , . OIS 5 . , OIS . E . . . OIS OIS . . 6.3 , F . ISO 14155 1 ISO 14155 2 . 7. . KS P ISO 14630 . OIS , . , OIS , . ： 20 g/mL ： 100 g/mL 1. ISO 10993 7 . , ISO 109
9、93 7 AAMI TIR No. 19 . OIS , ISO 13408 1 . P ISO 16671： 2006 5 10 3 (media fill study) . 2. ISO 13408 1 , , , . ISO 13408 1 , OIS . . (lyophilization) . 8. . , . , (6020) % . 45 , 40 % . , , , (EP, JP USP5 8 ), , . , OIS . , , , , . 9. 9.1 KS P ISO 11607, KS P ISO 14630 . 9.2 , , OIS . EN 868 1 . 10
10、. , EN 1041 . . KS P ISO 15223 . OIS , . , . . . , , , 2 . P ISO 16671： 2006 6 2 ( ) “ ” “ ” OIS ( 1 ) “LOT” , , . P ISO 16671： 2006 7 A() A.1 . A.2 A.2.1 10 mL , (titrant) 0.1 mL . A.2.2 A.2.3 A.2.4 (NaOH) 0.005 N A.2.5 (HCl) 0.01 N A.3 , . 25 mL(Vs) , (pH1) . 10 mL (A.2.1) , HCl 1.0 pH (pH2) . (Vt
11、) . NaOH . . )pHpH(12stVNV N： (normality) mol/L per pH . , . P ISO 16671： 2006 8 B() ： B.1 OIS . B.2 (viewing station) . B.2.1 . B.2.2 . B.2.3 . 2 000 lx , . . B.3 , . . . 5 . . , OIS . P ISO 16671： 2006 9 C() LOT ： C.1 , LOT . C.2 C.2.1 (liquid-borne particle) , (light- obscuration sensor) , . . .
12、. C.2.2 mL , . 10 m 10 % . C.2.3 , . C.2.4 1.2 m (porosity) . C.2.5 1025 m . , . . C.3 C.3.1 . . , , . , , . . . C.3.2 , . 5 mL 5 . 25 mL 10 m 25 , . . C.3.3 OIS , . . 25 . , . , . . 2 . (50.2) mL 4 10 m 25 m . , . P ISO 16671： 2006 10 D() ： D.1 OIS . , . , . D.2 D.2.1 . 10010 . 10 , , 0.25 . . 10 .
13、 . 25 mm 47 mm . D.2.2 2 . , 1020 . (episcopic brightfield) . , . D.2.3 2 % ( D.1 ) . 4 GFOV(Graticule Field Of View) . 100 10 m 25 m . P ISO 16671： 2006 11 1 GFOV 2 3 4 D.1 D.2.4 10 m . D.2.5 21 mm , . . . , 70550 kPa 1.2 m , (25 mm 47 mm , , , 1.0 m .) . . D.3 D.3.1 D.3.1.1 , 100 (0.5 m )/ft3(3 500 particles/m3) HEPA . 50 mL . , .
