KS P ISO 15814-2008 Implants for surgery－Copolymers and blends based on polylactide－In vitro degradation testing《外科植入物 共聚物和基于聚乳酸的混合物 体外降解试验》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 15814 KS P ISO 15814:2008 2008 11 7 http:/www.kats.go.krKS P ISO 15814:2008 : ( ) ( ) ( ) ( ) : ( ) ( ) ( ) ( ) : (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 15814:2008

2、 i ii .1 1 1 2 1 3 .2 4 .2 4.1 .2 4.2 2 4.3 .3 4.4 3 5 .4 5.1 .4 5.2 4 6 5 6.1 .5 6.2 .7 7 .7 8 .7 A( ) 8 9 KS P ISO 15814:2008 ii . KS P ISO 15814： 2003 . . , , . , , . KS P ISO 15814:2008 Implants for surgery Copolymers and blends based on polylactide In vitro degradation testing 1999 1 ISO 15814,

3、 Implants for surgery Copolymers and blends based on polylactide In vitro degradation testing . 1 / . / . (comonomers) (glycolid), (trimethylene carbonate), - (caprolactone) . . / . 2 . . ( ) . KS K ISO 2062, KS M ISO 178, KS M ISO 180, KS M ISO 527 1, 1： KS M ISO 527 2, 2： KS M ISO 527 3, 3： KS M I

4、SO 604, KS M ISO 1628 1, 1： KS P ISO 15814:2008 2 KS M ISO 3696, KS M ISO 6721 2, 2： KS M ISO 6721 4, 4： KS M ISO 14130, KS P ISO 10993 9, 9： KS P ISO 13781, (L- ) ISO 1805： 1973, Fishing nets Determination of breaking load and knot breaking load of netting yarns ISO 13934 1： 1999, Textiles Tensile

5、properties of fabrics Part 1： Determination of maximum force and enlongation at maximum force using the strip method 3 . 3.1 (copolymer) 3.2 (blend) 3.3 (resorption) 4 4.1 ( ) . . 4.2 4.2.1 ： (Srensen) KS M ISO 3696 2 2(potassium dihydrogenphosphate) 2 (disodium hydrogenphosphate) “ (sorensen)” (pH

6、7.4) . a) 1/15 mol/L KH2PO4： 1 L H2O 9.078 g KH2PO4b) 1/15 mol/L Na2HPO4： 1 L H2O 11.876 g Na2HPO4 2H2O a) 18.2 % b) 81.8 % . . KS P ISO 15814:2008 3 . 10 mL . (mL) (g) 30： 1 . . . 4.2.2 ( , , ) . . 4.2.3 (371) ( ). 4.2.4 pH . 4.2.5 0.1 mg . 4.3 4.3.1 pH 2 . 4 2 pH . pH , 0.1 mol/L NaOH pH 7.40.3 .

7、4.3.2 . . . 4.4 4.4.1 (371) . 4.4.2 . . 2 , 4 , 8 , 16 , 26 KS P ISO 15814:2008 4 6 , 12 , 26 , 39 , 52 6 . 5 5.1 1 . . . 3 . 6 . . . , . 5.2 5.2.1 . a) A (371) (603) . (371) . b) B (603) . 10 (221) . 5.2.2 7 . 2 , 4 , 8 , 16 , 26 7 . 6 , 12 , 26 , 52 5.2.3 . 1 . . 1 , . KS P ISO 15814:2008 5 1 , .

8、2 ( ) ( ) . 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 6721 4 KS M ISO 604 KS M ISO 14130 , , KS M ISO 527 3 KS K ISO 2062 ISO 1805 , ISO 13934 1 6 6.1 6.1.1 6.1.1.1 1 % 6.1.1.2 (desiccator) . . 6.1.1.3 5 kPa . 6.1.1.4 . . . 6.1.2 3 . . 6 . 6.1.3 . KS P ISO

9、15814:2008 6 6.1.4 6.1.4.1 . . , , . . 3 . 6.1.4.2 . , . . . . . 2 . 6.1.4.3 . 1.0 % . 6.1.4.4 . . . 6.1.5 . (DSC) , (GPC) , (SEM) . . a) KS M ISO 3146 (DSC) b) (AAS) c) (SEC) (GPC)： ASTM D 3536 . d) (GC) e) X f) , , (SEM) g) KS P ISO 15814:2008 7 . 6.2 . (250.1) KS M ISO 1628 1 . . 6 hexafluoroisop

10、ropanol(HFIP) . 50 mL (502) mg 0.1 % . 7 . a) b) 50 % . 8 . a) , , , b) (5.2.1 ) c) d) e) f) g) h) i) j) k) l) 1) ( .) 2) 3) , ： , ( , ) 4) KS P ISO 15814:2008 8 A ( ) A.1 . . A.2 (701) . A.3 24 2 . KS P ISO 15814:2008 9 1 KS M ISO 3146, ( ) 2 ASTM D 3536, Standard test method for molecular weight a

11、verages and molecular weight distribution by liquid exclusion chromatography(gel permeation chromatography GPC) 135513 7017 (02)60094114 (02)600948878 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 15814:2008 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Implants for surgeryCopolymers and blends based on polylactide In vitro degradation testing ICS 11.040.40