KS P ISO 10993-15-2006 Biological evaluation of medical devices－Part 15：Identification and quantification ofdegradation products from metals and alloys《医疗器械的生物学评估 第15部分 金属与合金降解产物的识.pdf

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2、n and quantification of degradation products from metals and alloys 2000 1 ISO 10993 15 Biological evaluation of medical devices Part 15： Identification and quantification of degradation products from metals and alloys . 1. . . . . . . . . (1011 ) 2 V 1 mV . 6.1.4 10 910 1A 1 % . 6.1.5 (working elec

3、trode) ( ) 6.1.6 ( , , ) 10 (vitreous carbon) . 6.1.7 6.1.8 pH 0.1 pH P ISO 10993 15： 2006 4 A . B . 6.2 . . 1015 KS M ISO 3696 2 (test cell) . 6.3 ( ) . 1050 (electrolyte cell) (371) . 30 100 cm3 min 1 . . . . (4.2 ). 6.4 (potentiodynamic) 2 . . (sweep rate) 1.0 mV s 1 , 10 mV s 1 . 2 000 mV 1.0 mA

4、 cm 2 , / ( 1 ). . 2 000 mV 1.0 mA cm 2 . 510 . / 510 , , . log / ( 2 ). (Ep) ( 1 ). . (Ep) . 6.5 (potentiostatic) . / . (Ep) 50 mV . (polarization duration) 1 5 . . 7. 7.1 7.1.1 (test cell) , ISO 3585 1 . 7.1.2 pH 0.1 pH P ISO 10993 15： 2006 5 EP 0 . 1 Ea EP , E, mV P ISO 10993 15： 2006 6 2 EP log

5、7.2 . 1 cm2 1 mL . . . (8. ). . / . 2 2 , . 7.3 pH . (371) (70.1) . pH . 8. (50) , . , . , ( , ICP 1.0106) . . , . P ISO 10993 15： 2006 7 . 9. . a) b) c) pH(0.1 ), (natural electrode) d) pH e) f) , log( ) g) h) Ep i) (sweep rate) j) k) ( , ) l) / m) (electrostatic test) (g/cm2/h) 7 (g/cm2/7 ) n) o)

6、(NHE) . p) q) r) P ISO 10993 15： 2006 8 A() 1 2 3 4 5 6 A.1 P ISO 10993 15： 2006 9 B() 1 9 2 10 3 11 KCL 4 12 5 13 6 14 7 15 8 B.1 P ISO 10993 15： 2006 10 C() C.1 KS M ISO 3696 2 . . C.2 (2 ) Na2HPO40.260 g/L NaCl 0.700 g/L KSCN 0.330 g/L KH2PO40.200 g/L NaHCO31.500 g/L KCl 1.200 g/L C.3 (2 ) NaCl 6

7、.800 g/L CaCl20.200 g/L KCl 0.400 g/L MgSO40.100 g/L NaHCO32.200 g/L Na2HPO40.126 g/L NaH2PO40.026 g/L P ISO 10993 15： 2006 11 1 ASTM G 5 94 Reference Test Method for Making Potentiostatic and Potentiodynamic Anodic Polarization Measurements 2 AFNOR NF 91 141G 5 94 Biodegradability of dental metal a

8、lloys Standardzation of electrochemical test 3 KS P ISO 10993 17 17： 4 KS P ISO 10271 15： 2006 10 23 135 513 701 7 (02)6009 4567 (02)6009 4887 8 http:/ 607 822 1 11( 10 ) (051)557 1239 Fax. (051)557 0430 702 845 2 1741( 3 ) (053)384 1562 4 Fax. (053)384 1565 790 380 627( 3 ) (054)278 9661 Fax. (054)

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10、( 1204 ) (041)589 0500 3 Fax. (041)589 0504 561 736 1 337 2( 7 ) (063)214 2235 7 Fax. (063)214 2238 506 301 621 15( 4 ) (062)953 1435 7 Fax. (062)953 1438 641 966 298 7 ( 6 ) (055)212 1212 Fax. (055)212 1213 683 804 758 2( 2 ) (052)289 6601 3 Fax. (052)289 6604 425 020 541 3( 4 ) (031)487 6191 4 Fax

11、. (031)487 6195 730 350 92 30( 8 ) (054)473 6954 Fax. (054)473 6955 480 848 2 487 6( 3 ) (031)829 8182 4 Fax. (031)829 8185 KOREAN STANDARDS ASSOCIATION KSKSKSSKSKS KSKS SKS KSKS SKSKS KSKSKSKS P ISO 10993 15： 2006 Biological evaluation of medical devices Part 15：Identification and quantification of degradation products from metals and alloys ICS 11.100.20