KS P ISO 10993-18-2009 Biological evaluation of medical devices－Part 18：Chemical characterization of materials《医疗器械的生物学评估 第18部分 材料的化学特性》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 10993 18 18： KS P ISO 10993 18:2009 2009 12 29 http:/www.kats.go.krKS P ISO 10993 18:2009 : ( ) ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2009 12 29 2009-0931 ： ： (ISO/TC 194) ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 10993 18:20

2、09 i ii 1 1 2 1 3 .1 4 .3 5 .3 6 .4 6.1 .4 6.2 1 .5 6.3 2 .5 6.4 3 .5 6.5 4 5 6.6 5 5 7 .6 7.1 .6 7.2 .7 7.3 8 7.4 .8 7.5 8 8 9 A( ) 10 B( ) .12 C( ) 15 16 KS P ISO 10993 18:2009 ii 2005 1 ISO 10993 18, Biological evaluation of medical devices Part 18： Chemical characterization of materials . . . ,

3、, . , , . KS P ISO 10993 18:2009 18： Biological evaluation of medical devices Part 18： Chemical characterization of materials 1 . . (KS P ISO 10993 1 ISO 14971) (KS P ISO 10993 17) , KS P ISO 10993 9, KS P ISO 10993 13, KS P ISO 10993 14 KS P ISO 10993 15 . KS P ISO 10993 (KS P ISO 10993 1, 4.2.1 ).

4、 . 2 . . ( ) . KS P ISO 10993 1, 1： KS P ISO 10993 17, 17： ISO 14971： 2007, Medical devices Application of risk management to medical devices 3 KS P ISO 10993 1 . KS P ISO 10993 18:2009 2 3.1 / 3.2 3 , , 3.3 3.4 , , (lay-flat) 3.5 3.6 (exhaustive extraction) 10 % . , , , . . , Tg . Tg . . . , . , .

5、, , . a) . b) . c) . 3.7 (simulated extraction) 3.6 KS P ISO 10993 18:2009 3 4 7. . 1 DMTA (Dynamic Mechanical Thermal Analysis) DSC (Differential Scanning Calorimetry) EDX-SEM X (Electron Dispersal X-ray Analysis Scanning Electron Microscopy) FTIR (Fourier Transform Infra Red spectroscopy) GC (Gas

6、Chromatography) MS a(Mass Spectroscopy) GPC (Gel Permeation Chromatography) HPLC (High Performance Liquid Chromatography) ICP (Inductively Coupled Plasma) IR (Infrared spectroscopy) NMR (Nuclear Magnetic Resonance spectroscopy) UV (Ultraviolet spectroscopy) XPS X (X-ray Photoelectron Spectroscopy) X

7、RF X (X-ray Fluorescence) 2D PAGE 2 (Two-dimensional Polyacrylamide Gel Electrophoresis) a (mass spectroscopy) GC-MS, LC-MS, MS-MS . 5 , . a) b) A . . , . , . , . . KS P ISO 10993 18:2009 4 . . . . . . . ( ) . / . , . , ( , , , , , , ) . , . . 6 6.1 A 5 . 6.2 6.6 . , . . , , . . (8. ). . ( ) . . KS

8、P ISO 10993 18:2009 5 . 1 2 4 ( 6.3 6.5) , . . 2 . , . , (KS P ISO 10993 1, 4.2.1 ). 6.2 1 / . (KS P ISO 10993 1, 3.3 4. B ). , . , , . ( , KS P ISO 5832 1) , . / . ( , ) . . (ISO 14971： 2007, 4.3 ). 6.3 2 / ( , ) . C 6.4 3 , (B.6 ) , . , . 6.5 4 (KS P ISO 10993 17 ISO 14971： 2007, 4.1 ). 6.6 5 KS P

9、 ISO 10993 18:2009 6 , . . 1 . . . 2 . 7 7.1 6. A / . 7.2 7.5 / . , / . 6.2 . 6. 1) 3) ( 6.2 6.4) . . . KS P ISO 10993 18:2009 7 7.2 2 ( .) MS, NMR, FTIR X X X ： (NMR) X X (IR/UV) X X (IR/NMR) X X (13C NMR ： DSC X (sol gel) X DMTA X (NMR) X X , , ： , / , , , , , , , , HPLC, GC X X GC X HPLC X X HPLC

10、 X X XRD(X-ray Diffraction) X X , XRF X FTIR X X XPS X X GC, HPLC X X ICP X X , HPLC X X GPC X X X X X / X KS P ISO 10993 18:2009 8 7.3 3 a( .) bXRF (C, S) (N, O, H) ICP X X XRD, X (相 ) EDX/SEM, XPS X X X EDX/SEM, XPS X X / X X a . b . . 7.4 4 a ( .) , XRF, ICP X X X (相 ) XRD X X ICP X X a , , , , .

11、 7.5 , ( ) / . 1 EN 12442 , . EN 455 3 (latex) . , , , KS P ISO 10993 18:2009 9 . , ( ), , , , , , , , , , . , . 2 (Ph.Eur./USP/JP) , ASTM F04 ( ). 5 ( .) 2D PAGE GPC X X X X FTIR 13C 1H 13C NMR X X X X ： X X X (13C NMR) DSC X X X , X X X ： 1 2 3 DMTA X X X / GPC X X X X X X HPLC GC 2D PAGE X X X X

12、X X X X 8 . . , . a) b) c) d) e) KS P ISO 10993 18:2009 10 A ( ) A.1 / (KS P ISO 10993 1, 4.2.1 ). A.2 A.1 . a) 1： b) 2： c) 3： d) 4： e) 5： 2) 4) , . . KS P ISO 10993 18:2009 11 A.1 . . ( : ) 1 , ? 2 . 3 , ? 4 , ?5 , . (KS P ISO 10993 1) (KS P ISO 10993 1, 3.2) KS P ISO 10993 18:2009 12 B ( ) B.1 5.

13、, . . B.2 B.8 . B.2 . . POLYETHYLENE (ethylene homopolymer) , POLYOLEFIN . B.3 B.3.1 . B.3.2 IUPAC IUPAC(International Union of Pure and Applied Chemistry) (Macromolecular Nomenclature Commission) . . . ( 12 ). B.3.3 CAS , USAN / CAS(Chemical Abstract Service) USAN(United States Accepted Names) . CA

14、S / USAN , . / USAN . B.4 . (B.2 ). , , , , , . KS P ISO 10993 18:2009 13 , OECD Guidelines 118： 199615 . B.5 , . a) ( ) b) Silastic, Dacron, Tetoron, Pellethane, Nylon, Teflon c) (IUPAC/CAS/USAN) d) Pellethane 2393-80AE, methylvinylpolysiloxane 0215 e) B.6.3 , , , , , f) (6.2 6.4 ). B.6 5. B.6.1 B.6.3 . B.6.1 .