GOST R ISO 14949-2014 Implants for surgery Two-part addition-cure silicone elastomers《外科植入物 双件式附加治疗的硅弹性体》.pdf

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1、 149492014 , ISO 14949:2001 Implants for surgery Two-part addition-cure silicone elastomers (IDT) 149492014 II 1 ( ) , 4 2 453 3 12 2014 . 2063- 4 14949:2001 . , (ISO 14949:2001 Implants for surgery Two-part addition- cure silicone elastomers) , A. 5 1.02012 ( 8). ( 1 ) , . () . , (gost.ru) , 2015 ,

2、 149492014 III . , / . , , , , ( ). , , , , . () . , , . 149492014 1 , Implants for surgery. Two-part addition-cure silicone elastomers 20160101 1 , ( ) . 2 : 34-1:1994. . . 1. , (ISO 34-1:1994, Rubber, vulcanized or thermoplastic Determination of tear strength Part 1: Trouser, angle and crescent te

3、st pieces) 48:1994. . ( 10 100 IRD) (ISO 48:1994, Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD) 527-2:1993. . . 2. (ISO 527-2:1993, Plastics Determination of tensile properties Part 2: Test conditions for moulding and extrusion plastics) 3417:1

4、991. . (ISO 3417:1991, Rubber Measurement of vulcanization characteristics with the oscillating disc curemeter) 6502:1999. . (ISO 6502:1999, Rubber Guide to the use of curemeters) 10993-1:1997. . 1. (ISO 10993-1:1997, Biological evaluation of medical devices Part 1: Evaluation and testing) 10993-5:1

5、999. . 5. in vitro (ISO 10993-5:1999, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity) 3 . 3.1 (catalyst): , , , , , , ( ), . , , : RMe2SiO(SiMe2O)x(SiMeRO)ySiMe2R, R R . 3.2 (crosslinking agent): , , , R“Me2SiO(SiMe2O)x(SiRMeO)ySiMe2R“, R“ , . 149492014 2 ( ) SiH, -

6、 , . 3.3 (filler): ( ) - 1 . 2 , , Me3SiX Me2SiX2, X - , HOMe2SiO(SiMe2O)p(SiMeRO)qSiMe2OH, R - . 3 , , , BaSO4. 3.4 (inhibitor): , , , 3.5 (lot): , , . , . 3.6 (manufacturer): , 3.7 (raw materials): , , 3.8 (silicone elastomer): , , . : R - , , , ; Me - CH3. 3.9 (silicon polymer): RMe2SiO(SiMe2O)x(

7、SiMeRO)ySiMe2R, R, , , , , . 1 2 149492014 3 3 : Vi - CH=CH2; Me - CH3; R R - , . , , , (. 5) . 3.10 (supplier): , / , . 3.11 (treating agent): , , . 3.12 (two-part addition-cure silicone elastomer): , , , SiH ; , - . () () () Si. 4 4.1 , 1. 1 , (% ) 60 80 40 1 5 0,5 1,04.2 , ( ) 149492014 4 (. 3.8)

8、 . ) () () , , - ( 2). b) . : ( Si / ) 100 = % Si. c) () () () () , , ( 2). d) () () () () , , ( 2). e) 95% ( 2). f) , , ( 2). 5 . ( ) . . , , 9001, 14969 . , , , , , . 10993-1. , 5-10 . 6 6.1 (2 0,2) 34-1 , . 6.2 , , . . (2962 5) -1, (2906 5) -1, (1260 5) -1 (1094 5) -1 (1022 5) -1. 6.3 6.3.1 149492014 5 .