KS P ISO 10993-19-2009 Biological evaluation of medical devices－Part 19：Physico-chemical morphological and topographical characterization of materials《医疗设备的生物学评估 第19部分 材料的物理化学、形态学和.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 10993 19 19： , KS P ISO 10993 19:2009 2009 12 29 http:/www.kats.go.krKS P ISO 10993 19:2009 : ( ) ( ) ( ) () ( ) : (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 19:

2、2009 i ii 1 1 2 1 3 .1 4 .2 5 .3 6 .3 6.1 .3 6.2 4 6.3 4 6.4 4 6.5 4 7 .5 8 8 A( ) .9 B( ) 10 11 KS P ISO 10993 19:2009 ii 2006 1 ISO/TS 10993 19, Biological evaluation of medical devices Part 19： Physico-chemical, morphological and topographical characterization of materials . . . , , . , , . KS P

3、ISO 10993 19:2009 19： , Biological evaluation of medical devices Part 19： Physico-chemical, morphological and topographical characterization of materials 1 , (PMT) . ( ) . , KS P ISO 10993 9, KS P ISO 10993 13, KS P ISO 10993 14 KS P ISO 10993 15 . KS P ISO 10993 18 . KS P ISO 10993 (KS P ISO 10993

4、1, 4.2 ). 2 . . ( ) . KS P ISO 10993 1, 1： KS P ISO 10993 18, 18： 3 KS P ISO 10993 1 KS P ISO 10993 18 . 3.1 ( ) KS P ISO 10993 19:2009 2 3.2 ( ) , 3.3 (topographical) ( ) 4 . NP： (nanoparticle) PMT： , (physico-chemical, morphological and topographical) 1 7. . 1 AES (Auger Electron Spectroscopy) AFM

5、/SPM / , (Atomic Force Microscopy/Scanning Probe Microscopy) BET (Brunauer-Emmett-Teller) CLSM (Confocal Laser Scanning Microscopy) DMTA (Dynamic Mechanical Thermal Analysis) DSC (Differential Scanning Calorimetry) EPMA (Electron Probe Microanalyser) ESC (Equilibrium Solvent Content) EWC (Equilibriu

6、m Water Content) EDX-SEM X (Energy Dispersive X-ray Analysis Scanning Electron Microscopy) FTIR , , (Fourier Transform Infra Red spectroscopy) FTIR-ATR , (Fourier Transform Infra Red spectroscopy Attenuated Total Reflectance) IR (Infra Red spectroscopy) OM ( )( (Optical Microscopy) QCM (Quartz Cryst

7、al Microbalance) SEM/TEM / (Scanning Electron Microscopy/Transmission Electron Microscopy) SPR (Surface Plasmon Resonance) TOF/SIMS 2 (Time of Flight Secondary Ionization Mass Spectroscopy) TMA (Thermal Mechanical Analyser) XPS/ESCA X / (X-ray Photoelectron Spectroscopy/Electron Spectroscopy for Che

8、mical Analysis) KS P ISO 10993 19:2009 3 5 (KS P ISO 10993 18 .) PMT . . a) b) PMT . . 1) PMT . 2) PMT (Dexter 50). 3) PMT / , . 4) ( , ), (Alaerts 46, Dewez 49). 5) ( , ) , . ( , , , ) ( , , , ) . . PMT PMT . , . . , . PMT ( , , , , , , , ) . , . 6 6.1 . , , . . . KS P ISO 10993 19:2009 4 7. 8. . .

9、 , , , , , , , , , . . . . , . 6.2 / . PMT (KS P ISO 10993 1, 3.2 4. )( A ). , . , , . / . , . PMT . . , . 6.3 , / , ( , ) . A , B ( 100 nm) . 6.4 , . 6.5 . / . KS P ISO 10993 19:2009 5 / . KS P ISO 10993 ISO 14971 . 7 6. / / PMT . 2 / . ( , ) / . . . , / . 6.2 . ( ) . . , ( ) / . ISO 22442 , . EN 4

10、55 3 (latex) . , , . , , , , , , , , , , , . , . , ASTM F04 . 2 , , , ( .) OM (BET) (mercury porosimetry) (helium pycnometry) SEM AFM SEM AFM ASTM F 1854 0139KS L ISO 1875422KS L ISO 1875723KS P ISO 10993 19:2009 6 2 , , , ( ) ( .) XRD(X-Ray Diffraction) OM DSC SEM/TEM AFM DMTA AFM OM AFM TEM / OM A

11、FM/SPM TEM ASTM F66535ASTM F75438ASTM F208142ASTM F218344Hasegawa Hashimoto 55Kajiyama 58Kajiyama 59 / ( ) ( ) QCM SPR CLSM RIA (repulsion) QCM SPR CLSM OM QCM CLSM EN 82827Collier et al.48Dewez et al.49Dexter et al.50Ebara and Okahata53Ikada56 Jenney Anderson57Kishida et al.60MacDonald et al.65 Nii

12、kura et al.69Quirk et al.71 Senshu et al.72 Senshu et al.74Tamada et al.76Wagner et al.77Weber et al.79 (repulsion) OM QCM CLSM KS P ISO 10993 19:2009 7 2 , , , ( ) ( .) IR , AFM/SPM ASTM D96831ASTM D104432ASTM D189433ASTM D406034ASTM F73236ASTM F73537ASTM F197841 XPS/ESCA TOF-SIMS FTIR/ATR FTIR- FT

13、IR- EDX-SEM (Raman) EPMA (“ , ”) SEM AFM/SPM KS A ISO 32741KS B ISO 42872KS B ISO 42883KS B ISO 5436 14KS B ISO 5436 25KS B ISO 1156211KS B ISO 1217912KS B ISO 13565 115KS B ISO 13565 216KS B ISO 13565 317KS L ISO 1875422KS L ISO 1875723EN 623 425Alaerts et al.46Ikada56Kajiyama et al.58Kumaki et al.

14、63Senshu et al.72Senshu et al.73Senshu et al.74 3 OM ( ) SEM ASTM F187740ISO 1331913KS A ISO 13320 114ISO/TS 1376218KS P ISO 1785321EN 725 526 SEM AFM/SPM OM (surface crazing) EWC ESC OM SEM TMA ISO 17190 520Moskala Jones66KS P ISO 10993 19:2009 8 8 , . a) b) c) d) , / PMT . . KS P ISO 10993 19:2009

15、 9 A ( ) 6.3 . . 5. 6. . a) b) c) KS P ISO 10993 19:2009 10 B ( ) (NP, 100 nm) , ( , m ) / . NP , , , (fullerene) ( ) . NP , . NP . NP . NP , (Donaldson 51, Dreher52Everitt Bermudez54, Lam 64, Warheit 78). (carbon black) NP , NP , (Brown 47, Wilson 80). NP , , (rat) (mouse) , (Everitt Bermudez54). N

16、P . , NP (Kreuter 61, Kreyling 62, Nemmar 67, Dewez 70). (polystyrene) NP , NP , . (Nemmar 68). NP (Stone 75). NP , mg NPs/kg / /kg NP . KS P ISO 10993 19:2009 11 1 KS A ISO 3274, (GPS)： ( ) 2 KS B ISO 4287, (GPS) , 3 KS B ISO 4288, (GPS) 4 KS B ISO 5436 1, (GPS)： 1： 5 KS B ISO 5436 2, (GPS)： 2： 6 K

17、S P ISO 5832 1, 1： 7 KS P ISO 10993 9, 9： 8 KS P ISO 10993 13, 13： 9 KS P ISO 10993 14, 14： 10 KS P ISO 10993 15, 15： 11 KS B ISO 11562, (GPS)： 12 KS B ISO 12179, (GPS)： ( ) 13 ISO 13319： 2000, Determination of particle size distributions Electrical sensing zone method 14 KS A ISO 13320 1, 1： 15 KS B ISO 13565 1, (GPS)： 1： 16 KS B ISO 13565 2, (GPS)： 2： 17 KS B ISO 13565 3, (GPS) ： ： 3： 18 ISO/TS 13762： 2001, Parti