KS P ISO 16429-2010 Implants for surgery-Measurements of open-circuit potential to assess corrosion behaviour of etallic implantable materials and medical devices over extended tim.pdf

1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 16429 KS P ISO 16429 :2010 2010 12 24 http:/www.kats.go.krKS P ISO 16429:2010 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2005 12 28 ：2010 12 24 2010-0626 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 16429:2010 i ii iii 1 1 2 1

2、 3 .1 4 2 4.1 .2 4.2 4 4.3 .4 5 5 5.1 5 5.2 5 5.3 0.1 . 5 5.4 (371) (, ) .5 6 .5 6.1 5 6.2 6 6.3 6 7 .6 7.1 .6 7.2 6 7.3 7 7.4 .7 7.5 .7 7.6 .7 8 .7 8.1 7 8.2 7 8.3 .7 9 .8 A() .9 A.1 .9 A.2 9 A.3 .9 10 KS P ISO 16429:2010 ii . KS P ISO 16429：2005 . . , , . , , . KS P ISO 16429:2010 iii 2004 1 ISO 1

3、6429, Implants for surgeryMeasurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods , . ASTM G 5 6 . , . . , . . , . , . , , , . . 0.9 % ( ) . . . A . KS P ISO 16429:2010 Implants for surgeryMeasurements of o

4、pen-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods 1 . . . . . 2 . . ( ) . KS M ISO 3696, KS P ISO 16428, 3 . 3.1 (corrosion potential) KS P ISO 16429:2010 2 3.2 (corrosion system) (, , ) 3.3 (environmental test condit

5、ions) , , , , () 3.4 (free corrosion potential) () KS D ISO 8044 3.5 (isotonic NaCl solution) (0.9 %) . 3.6 (open-circuit potential) ASTM G 15 (3.4) 3.7 (passive layer) ( ) . (KS D ISO 8044 ). 3.8 (reference electrode) 3.9 (working electrode) . 4 4.1 KS P ISO 16429:2010 3 , () KS P ISO 16428 0.9 % 9

6、 . KS P ISO 16428 . , A . ASTM G 5 6 . ( 1). , . ( 2). 1 () 2 3 4 5 () 6 7 8 9 1 3KS P ISO 16429:2010 4 1 () 2 (electrometer) 3 2 4.2 ( ) ( ) . , () . . , . . , , . 0.9 % . . . . 4.3 , , . , . , , . . KS P ISO 16429:2010 5 (mechanism) . 5 5.1 . ASTM G 5 6 . 1 . / , ( ) . (ISO 3585 2 ). , (KS P ISO 1

7、6428). 5.1.1 5.1.2 (saturated calomel electrode, SCE) . , 5 . 5.1.3 , 2 mm . 5.1.4 5.1.5 5.2 (10 11) 1 mV , . 1 V1.5 V . 5.3 0.1 . 5.4 (371) (, ) , ( ) . 66 6.1 , (, , , , ) . . KS P ISO 16429:2010 6 , . , . . 6.2 . . . ( , , ) , , , , , . . KS M ISO 3696 . ( , ) , KS M ISO 3696 240 600 SiC , , , .

8、. 6.3 . , . , . . . 7 7.1 KS P ISO 16428 . 7.2 KS P ISO 16428 0.9 % . , (KS P ISO 16428 ASTM F 2129 4). ( A ). 0.9 % . , 0.9 % . KS P ISO 16428 ASTM F 2129 . KS P ISO 16429:2010 7 7.3 (371) . 7.4 , . 7.5 . . . . a) b) ( ) , , . 30 . 7.6 . 5001 000 mL . 10 mL/cm 25 . 8 8.1 . . . . . 2 mm . . 8.2 . 3

9、. , . 8.3 KS P ISO 16429:2010 8 . . . 9 . a) b) c) d) e) f) , , g) 1) 2) 3) 4) 5) h) i) j) ( , .) k) () KS P ISO 16429:2010 9 A () A.1 . A.2 A.3 . . A.2 0.9 % 6.87.4 . 9 . a) pH 6 b) pH 5 c) pH 4 d) pH 3 e) pH 2 A.3 0.9 % . a) 1.8 % b) 2.7 % c) 3.6 % d) 4.5 % KS P ISO 16429:2010 10 1 KS D ISO 11845,

10、 2 ISO 3585, Borosilicate glass 3.3Properties 3 KS D ISO 8044, 4 ASTM F 2129, Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices 5 ASTM G 3, Standard Practice for Conventions Applicable to Electroche

11、mical Measurements in Corrosion Testing 6 ASTM G 5, Standard Reference Test Method for Making Potentiostatic and Potentiodynamic Anodic Polarization Measurements 7 ASTM G 15, Standard Terminology Relating to Corrosion and Corrosion Testing 8 JIS T 0302, Testing method for corrosion resistance of met

12、allic biomaterials by anodic polarization measurement 9 Pharmacopoeia Helv. , 1997, CH 196 with European Pharmacopoeia (Ph. Eur. 3, 1997) Isotonic sodium chloride solution 9 g/L infundible (Natrii chloridi solutio infundibilis 9 g/L) 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 16429

13、 :2010 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Implants for surgery Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods ICS 11.040.40 Korean Agency for Technology and Standards http:/www.kats.go.kr