KS P ISO 14949-2009 Implants for surgery－Two-part addition-cure silicone elastomers《外科植入物 两节附加加工的硅弹性体》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 14949 2 KS P ISO 14949:2009 2009 12 21 http:/www.kats.go.krKS P ISO 14949:2009 : ( ) ( ) () () ( ) : (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 14949:2009 i . ii 1 1 2

2、1 3 .1 4 (formulation) .4 4.1 (composition).4 4.2 (raw materials assessment)4 5 (biocompatibility)4 6 (characterization and testing) .5 6.1 (test slab preparation) .5 6.2 (identification) .5 6.3 (Purity testing) 5 6.4 (cure rate).6 6.5 (physicomechanical properties and characterization) .6 7 (docume

3、ntation)7 7.1 (data sheet) 7 7.2 (certificate of analysis) .7 A( ) 8 A.1 (objective)8 A.2 (principle).8 A.3 (sample preparation)8 A.4 (reagents) 8 A.5 (appratus and glassware) .9 A.6 (experimental precautions)10 A.7 (procedure)10 A.8 (calculation) .11 A.9 (specification).11 B( ) 12 B.1 (objective)12

4、 B.2 (principle).12 B.3 (sample preparation)12 B.4 (reagent)12 B.5 (apparatus and glassware) .12 B.6 (experimental precautions)13 B.7 (procedure)13 B.8 (calculation) .13 B.9 (specification).14 15 KS P ISO 14949:2009 ii 2001 1 ISO 14949, Implants for surgery Two-part addition-cure silicone elastomers

5、 , . . , . , 2 ( ) . 2 , , , . 2 , 2 ( ) . , . KS P ISO 14949:2009 2 Implants for surgery Two-part addition-cure silicone elastomers 1 2 . 2 . . ( ) . KS M ISO 34 1, 1： , KS M ISO 527 2, 2： KS M ISO 3417, KS M ISO 6502, KS P ISO 10993 1, 1： KS P ISO 10993 5, 5： ISO 48： 1994, Rubber, vulcanized or th

6、ermoplastic Determination of hardness(hardness between 10 IRHD and 100 IRHD) 3 . 3.1 (catalyst) , , , , R R RMe2SiO (SiMe2O)x (SiMeRO)ySiMe2R . 3.2 (crosslinking agent) R RMe2SiO (SiMe2O)x(SiRMeO)ySiMe2R , , KS P ISO 14949:2009 2 Si SiH ( ). 3.3 (filler), (reinforcing agent) 1 . 2 X Me3SiX Me2SiX2 ,

7、 R HOMe2SiO(SiMe2O)p(SiMeRO)qSiMe2OH . 3 (： BaSO4) . 3.4 (inhibitor) 3.5 (lot), (batch) . 3.6 (manufacturer) 3.7 (raw materials) 2 3.8 (silicone elastomer) R ： , , , . Me ： CH33.9 (silicone polymer) RMe2SiO(SiMe2O)x(SiMeRO)ySiMe2R . R , , KS P ISO 14949:2009 3 , R , . 1 2 3 Vi ： CH CH2 Me ： CH3 R R

8、, , . . (5. ) . 3.10 (supplier) 2 3.11 (treating agent) , 3.12 2 (two-part addition-cure silicone elastomer) SiH . KS P ISO 14949:2009 4 Si . 4 (formulation) 4.1 (composition) 1 . 1 2 (% ) 60 80 40 1 5 0.5 1.0 4.2 (raw materials assessment) ( 10 ) 2 (3.10 ) . a) (2 ) . b) . ( mg Si/ )100 % Si . c) (

9、2 ) . d) (2 ) . e) 95 % (2 ). f) (2 ) . 5 (biocompatibility) , . ( , ) , . . KS Q ISO 9001, Pt ( ) ( ) ( )KS P ISO 14949:2009 5 KS P ISO TR 14969 . , . KS P ISO 10993 1 . 5 10 . 6 (characterization and testing) 6.1 (test slab preparation) (20.2) mm KS M ISO 34 1 . 6.2 (identification) . . (2 9625) c

10、m 1, (2 9065) cm 1, (1 2605) cm 1 (1 0945) cm 1 (1 0225) cm 1 . 6.3 (Purity testing) 6.3.1 (metal contamination) 2 . , . ( BaSO4 ) . Al 20010 6 P, Ti, Fe 5010 6 Na, Mg, Ca 10010 6 Sb, Ge, Mn, Mo, Pb, Sn, Cr, Bi, V, Ag, Co, Ni, Cu, Zr, Ba, As, Zn, Se, Cd, Hg, Tl 1010 6 . 6.3.2 (particulate contaminat

11、ion) 2 . 100 mm100 mm2 mm . 10 2 . KS P ISO 14949:2009 6 2 m 400 399300 2 299200 4 199100 4 6.3.3 (cytotoxicity) KS P ISO 10993 5 . , . 6.3.4 (substances soluble in hexane) A . . 3 % . 6.3.5 (determination of volatile matter) B . . 2.0 % . 6.4 (cure rate) KS M ISO 3417 KS M ISO 6502 2 . . , . , 90 %

12、 . . 6.5 (physicomechanical properties and characterization) . . ( ) . KS M ISO 527 2, KS M ISO 34 1 ISO 48 . (%) KS P ISO 14949:2009 7 (MPa) 100 % (MPa) , B(kN/m) (IRHD) (kg/m3) 7 (documentation) 7.1 (data sheet) 2 . a) , b) c) d) A B , ( ) e) f) g) / h) , . . i) 90 % ( KS M ISO 3417). 7.2 (certifi

13、cate of analysis) 6. “ 2 KS P ISO 14949 .” . KS P ISO 14949:2009 8 A ( ) A.1 (objective) . ( ) . A.2 (principle) ( ) . % . A.3 (sample preparation) A.3.1 (general) . ( ) (tubing) A.3.2 (non-cured elastomer) (KS M ISO 34 ) (2.00.2) mm . ( , , , ) . , A.6 5 mm5 mm . . . . A.3.3 (already processed “cur

14、ed” elastomer) , . . A.4 (reagents) . KS P ISO 14949:2009 9 A.4.1 n- (n-hexane) A.4.2 (isopropanol) . A.5 (appratus and glassware) . A.5.1 (volumetric pipettes) A , 25 mL . A.5.2 500 mL (500 mL glass flasks) 450 . 6 A.5.3 500 mL (500 mL flasks) . A.5.4 100 mL (100 mL glass volumetric flasks) A.5.5 1

15、00 mL (100 mL glass beakers) A.5.6 (condensers) A.5.7 (sintered glass filter funnel) 4 . A.5.8 (vacuum filtration flask) A.5.9 (vacuum pump) . A.5.10 (electrothermal glass flask heater) A.5.11 (thermostatted water bath) 100 . A.5.12 (ventilated oven) 100 105 . A.5.13 (cork rings) KS P ISO 14949:2009

16、 10 A.5.14 (desiccator) . A.5.15 (polytetrafluoroethylene(PTFE) cutting surface and film) A.5.16 (scalpel) 5 mm5 mm . A.5.17 (analytical balance) 0.1 mg . A.6 (experimental precautions) . . . . . . . . A.7 (procedure) A.7.1 (number of experiments) 3 . . A.7.2 (extraction) 5 mm5 mm . n- . 2.0 g n- 10

17、0 mL . PTFE . 4 . . 1 . A.7.3 (filtration) KS P ISO 14949:2009 11 ( 4) . 5 mL n- . 100 mL . n- 100 mL . A.7.4 (evaporation) 2 100 mL ( , .) 100 105 1 , 1 . 25 mL A.7.3 100 mL . 1 , 100 105 1 . 1 . A.7.5 (weighing) . . A.8 (calculation) . % residue (mr mt)400/mi mt： mr： mi： ： a) b) c) d) A.9 (specifi

18、cation) % 3 % . KS P ISO 14949:2009 12 B ( ) B.1 (objective) . 1 . B.2 (principle) , . B.3 (sample preparation) A.3 . B.4 (reagent) B.4.1 (isopropanol) (reagent grade) B.5 (apparatus and glassware) B.5.1 (aluminium dishes) 86 mm, 25 mm . B.5.2 (desiccators) . B.5.3 (scalpel) 5 mm5 mm . B.5.4 (ventil

19、ated oven) 200 . B.5.5 (analytical balance) 0.1 mg . KS P ISO 14949:2009 13 B.6 (experimental precautions) . . . B.7 (procedure) B.7.1 (number of experiments) . B.7.2 (drying of elastomer samples) 30 g 5 mm5 mm . 10 g ( , ) 48 . B.7.3 (drying of dishes) , 200 4 1 . B.7.4 (oven heating of elastomer samples) 48 , 10 g (B.7.2) , 4 200 1 . B.7.5 (weighing) . . B.8 (calculation) . % mi (mf mt)100 /mi