KS P ISO 17853-2009 Wear of implant materials－Polymer and metal wear particles－Isolation characterization and quantification《植入材料的磨损 聚酯和金属磨损粒子 离析、表征和量化》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 17853 , KS P ISO 17853:2009 2009 12 21 http:/www.kats.go.krKS P ISO 17853:2009 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ：2004 11 22 ：2009 12 21 2009-0834 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 17853:2009 i ii 1 1 2 .1

2、 3 (methods of sampling and analysis of polymer and metal wear debris from tissue samples) 1 3.1 (principle).1 3.2 (reagents) 2 3.3 (apparatus) 2 3.4 (storage and preparation of samples)3 3.5 (procedure for polymer particle isolation).4 3.6 (procedure for metal particle isolation).4 3.7 (collection

3、of particles)5 3.8 (particle size and shape characterization) .6 3.9 6 3.10 (calculation of the number of particles).6 3.11 (UHMWPE particle verification) .7 3.12 (metal particle verification)7 4 (methods of sampling and analysis of polymer and metal particles from joint simulator lubricants)7 5 (te

4、st report)8 9 KS P ISO 17853:2009 ii 2003 1 ISO 17853, Wear of implant materials Polymer and metal wear particles Isolation, characterization and quantification , . . . . KS P ISO 17853:2009 , Wear of implant materials Polymer and metal wear particlesIsolation, characterization and quantification 1

5、. , , . . , . poly(methylmethacrylate)(PMMA) . 2 . 2.1 (polymer wear debris) ultra-high molecular weight polyethylene(UHMWPE) 2.2 (metal wear debris) 3 (methods of sampling and analysis of polymer and metal wear debris from tissue samples) 3.1 (principle) (3.5.1 3.6.1 ). . KS P ISO 17853:2009 2 , 3.

6、5 3.6 . , (SEM) (TEM) . . 3.2 (reagents) , . 0.2 m (3.3.4) . 3.2.1 (sodium hydroxide solutions)(NaOH) c 0.1 mol/L 5 mol/L 3.2.2 (hydrochloric acid solution) ( ) c 0.01 mol/L 3.2.3 (sucrose solutions) 1.35 g/cm3, 1.17 g/cm3, 1.08 g/cm3, 1.04 g/cm3 1.02 g/cm33.2.4 (isopropanol-water mixtures) 0.96 g/c

7、m3 0.90 g/cm33.2.5 (distilled water) 3.2.6 (papain solution) 100 m, N 3.26 mg, 9 mL 1 mL (3.2.7) . 3.2.7 (phosphate buffer) 100 mL 3.55 g (Na2HPO4) 3.45 g (NaH2PO4) (pH) 6.5 , 0.744 g (EDTA) . 3.2.8 ethylenediaminetetraacetic acid solution(EDTA) 1.75 L 250 g . 3.2.9 (fixative) 3.2.10 high density po

8、lyethylene(HDPE) powder( 10 m) 3.2.11 (titanium powder)( 10 m) 3.3 (apparatus) 0.2 m (3.3.4) KS P ISO 17853:2009 3 3 . 3.3.1 (lint-free cloth) 3.3.2 (ultracentrifuge) 3.3.3 (ultracentrifuge tubes) 3.3.4 (filters) 0.2 m . 3.3.5 (polycarbonate membrane filters) 0.1 m 0.02 m . 3.3.6 (water bath) 3.3.7

9、(pipettes) 1 . 3.3.8 (petri dishes) . 3.3.9 (ultrasonicator) 3.3.10 (polarizing light microscope) 3.3.11 scanning electron microscope(SEM) 3.3.12 transmission electron microscope(TEM) 3.3.13 (aluminium stub) 3.3.14 (carbon sticker) 3.3.15 Fourier transform infra-red(FTIR) spectroscope 3.3.16 (syring

10、e) . 3.3.17 (filtration unit) 3.3.18 (balance) 0.1 mg . 3.4 (storage and preparation of samples) 70 . , . . KS P ISO 17853:2009 4 (3.10 ). . , . . . 3.5 (procedure for polymer particle isolation) 3.5.1 (tissue digestion) . 24 2： 1( ) ： . . 5 g 10 mL 5 moL/L , 1 3 65 . . 3.5.2 (purification of the po

11、lymer particle yield) ( 1.02 g/cm3) 4/3 , . 2 3 100 000 g . 65 . 10 , 80 1 . 0.90 g/cm3 0.96 g/cm3 2 . 20 1 100 000 g . , 2 . , . 10 . , . . . 3.6 (procedure for metal particle isolation) 3.6.1 (tissue digestion) KS P ISO 17853:2009 5 . 5 g 10 mL 5 moL/L , 65 1 . 3.6.2 (purification of the metal par

12、ticle yield) . 15 100 000 g 1 . . 10 . 1.04 g/cm3, 1.08 g/cm3, 1.17 g/cm3 1.35 g/cm3 . . 2 3 100 000 g . , . , 65 . 3 . , . 65 3 . , . . 0.01 moL/L 0.1 moL/L 6.5 . 18 24 65 . , . 3 . , 10 mL 10 . , . 3.7 (collection of particles) 0.1 m . 10 m 300 m ( ). , . . , . 1 (0.045 mL) , . . . . , . , 0.1 m .

13、 . , 1： 10 1： 100 . (100 ) KS P ISO 17853:2009 6 . 3.8 (particle size and shape characterization) 0.1 m . . . 10 keV , 15 keV . 0.1 m 100 5 000 . 10 m 1 000 . , , ( ), , , ( / ) (2/4 ) , . . 0.1 m . . 80 keV 20 000 25 000 . 1 (SEM) , 0.1 m (TEM) . 2 100 . 3 . 4 . 5 0.1 m , . 3.9 (HDPE) ( 10 m)(3.2.1

14、0) ( 10 m)(3.2.11) . 3.5 3.6 , , . 0.1 mg ( .) . 3 ( ). , 3.10 . 3 . . 3.10 (calculation of the number of particles) , . . KS P ISO 17853:2009 7 10 m 0.1 m 1 000 20 00025 000 . . . a) 3.01 g . 1/3 250 . 141 5 000 7 . b) 1 3.3510 10m2 7 2.3510 9m2 (0.004 5)2 6.3510 5m2 (1416.3610 5)/2.3510 9 3.82106c

15、) 1/3 250 3.01 g 1.241010d) 37.4 % 3.01 g 1.2410101.626 2.021010e) 6.70109 , . 3.11 (UHMWPE particle verification) . potassium bromide(KBr) . . ( ASTM F1877 98 ). . 3.12 (metal particle verification) SEM EDS( ) TEM EDS( ) . 4 (methods of sampling and analysis of polymer and metal particles from join

16、t KS P ISO 17853:2009 8 simulator lubricants) . , . , . . , 3.5 3.6 . 5 moL/L . 5 (test report) . a) ( , , , ) b) , c) ( .) d) e) f) , g) h) i) j) , k) , / KS P ISO 17853:2009 9 1 ASTM F 1877 98, Standard practice for characterization of particles , 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 17853:2009KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Wear of implant materials Polymer and metal wear particles Isolation, characterization and quantification ICS 11.040.40