KS P ISO 16428-2007 Implants for surgery-Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices《外科植入物 可植入物质.pdf

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1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 16428 KS P ISO 16428： 2007 (2012 ) 2007 12 18 http:/www.kats.go.krKS P ISO 16428： 2007 : ( ) ( ) () ( ) () ( ) () ( ) : (http:/www.standard.go.kr) ： ：2007 12 18 ：2012 12 6 20120679 ： ： (TC150) ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO

2、 16428： 2007 i ii 1 1 2 1 3 .1 4 2 4.1 .2 4.2 .2 5 3 5.1 3 5.2 3 5.3 pH 3 5.4 (aeration) .3 5.5 .4 5.6 4 5.7 4 6 .4 7 .4 7.1 .4 7.2 4 A( ) .6 B( ) 7 8 KS P ISO 16428： 2007 ii 2005 1 ISO 16428, Implants for surgery Test solutions and environmental conditions for static and dynamic corrosion tests on

3、implantable materials and medical devices , . . . , . (NaCl) . . (Cl-) , . . KS P ISO 16428： 2007 (2012 ) Implants for surgery Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices 1 , , . , , . . , (fretting) . . , . 2 . . (

4、) . KS M ISO 3696： 2005, 3 , . 3.1 (corrosion fatigue testing) / . 3.2 (environmental testing conditions) ( ) , , , pH, . KS P ISO 16428： 2007 2 3.3 (isotonic sodium chloride solution) ( ) (0.9 % NaCl ) , . 3.4 (Ringers solution) ( ) A 3.5 (static and dynamic test) . 4 4.1 . 3, (flushing) . . , , .

5、4.2 4.2.1 . 4.2.2 , (pitting) , , . . , . / . 4.2.3 . , KS P ISO 16428： 2007 3 . . ：(clamping) ( )(5.1) . , (5.) . 4.2.4 , . . 5 5.1 0.9 %( ) , KS M ISO 3696 9 g . 1 000 mL ( 3 ). , . , , . . “ ” . A A.1 . A.2 pH . ASTM F 2129： 2003 X28 . 5.2 , (371) . 5.3 pH pH . pH . pH (CO2) . pH . ( ) . , pH . /

6、 , . 5.4 (aeration) , . a) b) KS P ISO 16428： 2007 4 , . . . 5.5 10 mL/cm2 1. 5.6 , . , (reservoir vessel) (pumping) . , . 5.7 . . , . , . (galvanic corrosion) . . 6 ( 2 ), . . , ( B.2 ). . , . 7 7.1 . B.2 . 7.2 . a) (KS P ISO 16428： 2007) b) c) d) KS P ISO 16428： 2007 5 e) pH ( ) f) g) h) i) j) KS

7、P ISO 16428： 2007 6 A ( ) A.1 (Isotonic Ringers solution) . NaCl 8.36 g KCl 0.3 g CaCl20.15 g KS M ISO 3696 1 000 mL 4 . (electrolytorum solutio composita) . 5. CaCl2 0.1 % NaHCO3 . 121 . 6. A.2 pH 0.9 % (Aqueous 0.9 % NaCl solution with low pH in the acidic range) 5.1 0.9 %( ) pH 2 HCl . . KS P ISO

8、 16428： 2007 7 B ( ) B.1 , . . . , . . . . B.2 , . . ( , ) , . ( ) ( ) , , . KS P ISO 16428： 2007 8 1 KS D ISO 8044： 2003, 2 KS D ISO 11845： 2003, 3 ASTM F 1801： 1997, Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials 4 Pharmacopoeia Helv. VIII, 1997, CH 196 with European

9、 Pharmacopoeia (Ph.Eur. 4, 2001) Isotonic sodium chloride solution 9 g/L infundible (Natrii chloridi solutio infundibilis 9 g/L) 5 Pharmacopoeia Helv. VIII, 1997, CH 94 with European Pharmacopoeia (Ph.Eur. 4, 2001) Electrolyte solution (Electrolytorum solutio composita) 6 Pharmacopoeia Helv. VII, 19

10、91, Electrolytorum Solutio Composita (Zusammengesetzte Elektrolytloesung) 7 Roempps Chemie Lexikon Otto-Albrecht Neumueller, 8th Edition, Frankhsche Verlagshandlung, Stuttgart 8 ASTM F 2129： 2004, Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the C

11、orrosion Susceptibility of Small Implant Devices 9 JIS T 0302, Testing method for corrosion resistance of metallic biomaterials by anodic polarization measurement 153787 1 145 3(16) (02)26240114 (02)26240148 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 16428： 2007KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Implants for surgery Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices ICS 11.040.40