KS M ISO 16037-2008 Rubber condoms for clinical trials－Measurement of physical properties《临床试验用橡胶避孕套 物理特性的测量》.pdf

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3、M ISO 4074 13 . , ( ) . 5.2 , . 6 6.1 ( ) ( ) . . 6.2 0.010 mm , 5 mm2 mm 22 kPa4 kPa 13 . , 4 . 6.3 KS M ISO 4074 . KS M ISO 4074 . . 0.5 mm 1 mg . . t 0.026 8 m/w t ： (mm) m ： (mg) w ： (mm) . . 7 13 , ( ) , . ( 0.01 mm ) ( 1 mm ) . , ( ) . 8 KS M ISO 4074 315 ( 500 ) . . KS M ISO 4074 . ( ) , (KS

4、M ISO 4074 / ) . KS M ISO 16037:2008 3 (stem and leaf diagrams) . KS M ISO 4074 , , . 2 000 . 9 9.1 KS M ISO 4074 20 . . a) ( 0.5 mm ) ( 0.001 mm ) b) ( 0.5 mm ) ( 1 mg ) KS M ISO 4074 . 100 %, 300 % 600 % ( 0.1 N ) ( ) . 9.2 100 %, 300 % 600 % , ( ) ( ) . 9.1 b) , . mwF 935.0 ： (MPa) F ： (N) w ： (m

5、m) m ： (mg) 9.3 - , . KS M ISO 37 ISO 1 2 . (20 mm) . ( 0.001 mm ) . 10 32 , KS M ISO 4074 , ( 10 mg ) . ( ) . 11 11.1 KS M ISO 4074( ) 315 . ( 25 mm ) 1 mm . 11.2 , ( ) . KS M ISO 16037:2008 4 . , 2 000 . 12 ( ) ( / ) ( ), , . 13 . 6 , 6 . . KS M ISO 16037:2008 5 1 KS P ISO 10993 1, 1： 2 KS P ISO 1

6、0993 10, 10： 3 KS P ISO 14155( ), 4 ISO 14971, Medical devices Application of risk management to medical devices 135513 7017 (02)60094114 (02)600948878 http:/ KS M ISO 16037:2008 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Rubber condoms for clinical trials Measurement of physical properties ICS 11.200 Korean Agency for Technology and Standards http:/www.kats.go.kr