KS P ISO 13781-2008 Poly(L-lactide) resins and fabricated forms for surgical implants－In vitro degradation testing《外科值入物用聚L 丙交酯树脂及其制造形状 体外分解试验》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 13781 (L- ) KS P ISO 13781:2008 2008 11 7 http:/www.kats.go.krKS P ISO 13781:2008 : ( ) ( ) ( ) ( ) : ( ) ( ) ( ) ( ) : (http:/www.standard.go.kr) ： ：2003 12 19 ：2008 11 7 2008-0746 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 13781:

2、2008 i ii .1 1 1 2 1 3 .2 4 .2 4.1 .2 4.2 2 4.3 .3 4.4 3 4.5 4 5 4 5.1 4 5.2 .5 6 .6 6.1 .6 6.2 .6 6.3 .6 6.4 7 7 .7 8 .8 A( ) .9 B( ) 10 KS P ISO 13781:2008 ii . KS P ISO 13781： 2003 . . , , . , , . KS P ISO 13781:2008 (L- ) Poly(L-lactide) resins and fabricated forms for surgical implants In vitro

3、 degradation testing 1997 1 ISO 13781, Poly(L-lactide) resins and fabricated forms for surgical implants In vitro degradation testing . 1 (L- ) . / . (L- ) . a) b) c) ( ) (L- ) . . , (L- ) / / (stereoisomer) . 2 . . ( ) . KS K ISO 2062, KS M ISO 178, KS M ISO 180, KS P ISO 13781:2008 2 KS M ISO 527

4、1, 1： KS M ISO 527 2, 2： KS M ISO 527 3, 3： KS M ISO 604, KS M ISO 1628 1, 1： KS M ISO 6721 2, 2： ISO 1805： 1973, Fishing nets Determination of breaking load and knot breaking load of netting yarns ISO 5081： 1977, Textiles Woven fabrics Determination of breaking strength and elongation(Strip method)

5、 ASTM D 4475： 1990, Test method for apparent horizontal shear strength of pultruded reinforced plastic rods by the short-beam method DIN 53137： 1977, Testing of filter paper, determination of rate filtration on freely suspended filters 3 . 3.1 (degradation) / , . 3.2 (in vitro degradation) 3.3 (reso

6、rbable polymer) , 3.4 (L- ) poly(L-lactide) L- 4 4.1 ( ) . . 4.2 4.2.1 ： (Srensen) 2 2 (potassium dihydrogen phosphate) 2 (disodium hydrogen phosphate) . , . KS P ISO 13781:2008 3 a) 1/15 mol/L KH2PO4, 1 L 9.078 g KH2PO4 b) 1/15 mol/L Na2HPO4, 1 L 11.876 g Na2HPO4 2H2O a) 18.2 % b) 81.8 % . . pH 7.4

7、0.2 . 4.2.2 ( , , ) . . 4.2.3 1 . 4.2.4 pH pH 6 pH 80.2 . 4.3 4.3.1 pH 2 . pH 2 . a) ： 6 b) ： pH c(NaOH) 0.1 mol/L pH 7.40.2 . 4.3.2 . , . . 4.4 4.2.1 4.2.2 , . 10 mL . (mL) (g) 30： 1 . . 4.2.3 (371) . KS P ISO 13781:2008 4 , . 4 , 26 , 104 6 . 4.5 4.5.1 . . . 4.5.2 4.2.1 4.2.2 , . 10 mL . (mL) (g)

8、30： 1 . . 4.2.3 (701) . , . 24 . 5 , . KS M ISO 3146 (DSC) (AAS) (SEC) (GPC) (GC) X (SEM)( , , ) . 5.1 5.1.1 5.1.1.1 1 % 5.1.1.2 (Desiccator) . KS P ISO 13781:2008 5 5.1.1.3 . 5.1.1.4 160 Herzberg(DIN 53137 ) . DIN 12448 589/4 . 5.1.2 . . 3 . , . , . 5.1.3 5.1.1.3 5.1.1.2 . 5.1.1.1 1.0 % . . 5.1.1.4

9、 . 1.0 % . 5.1.1.4 . . . 1.0 % . 5.1.4 . (： , , ) . 5.2 (Ubbelohde) Oc KS M ISO 1628 1 . KS P ISO 13781:2008 6 . . 50 mL (502) mg 0.1 % . 6 6.1 . . . . . 6.2 . . , . (371) . 6.2.1 (371) (6015) . . , . 6.2.2 . . 6.2.3 (371) 1 . 6.3 3 . 3 . KS P ISO 13781:2008 7 . , . 6.4 . , , . . 1 . 1 , . ( , , ) .

10、 . , . 1 KS M ISO 178 KS M ISO 180 KS M ISO 527 1 KS M ISO 527 2 KS M ISO 6721 2 KS M ISO 604 ASTM D 4475 , KS M ISO 527 3 KS K ISO 2062 ISO 1805 , ISO 5081 ( ) ( ) . 7 . a) b) 100 % , c) 0.1 dL/g KS P ISO 13781:2008 8 8 . a) , , , b) c) pH d) e) f) , , , g) ( SEM) h) KS P ISO 13781:2008 9 A ( ) , .

11、 . . , . . KS P ISO 13781:2008 10 B ( ) 1 KS M ISO 3146, ( ) 2 DIN 12448： 1977, Paper laboratory ware Filter paper (L-) 135513 7017 (02)60094114 (02)600948878 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 13781:2008 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Poly(L-lactide) resins and fabricated forms for surgical implants In vitro degradation testing ICS 11.040.40