KS P ISO 7151-2008 Surgical instruments－Non-cutting articulated instruments－General requirements and test methods《外科器械 非切割的、铰接的器械 通用要求和测试方法》.pdf

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3、Surgical instruments Non-cutting, articulated instruments General requirements and test methods , . 1 . 2 . . ( ) . KS M ISO 6508 1, 1： (A, B, C, D, E, F, G, H, K, N, T ) ISO 683 13, Heat-treated steels, alloy steels and free-cutting steels Part 13： Wrought stainless steels ISO 6507 1, Metallic mate

4、rials Vickers hardness test Part 1： Test method ISO 7153 1, Surgical instruments Metallic materials Part 1： Stainless steel 3 1 ISO 7153 1 . 1 ISO 71531 , B A, B M A B B A, B, L, M, N, O P KS P ISO 7151:2008 2 4 4.1 M 4.1.1 4.1.2 4.1.3 . 4.1.2 KS M ISO 6508 1 ISO 6507 1 4048 HRC( 390485 HV) . 4 . 4.

5、1.3 ISO 6507 1 1 000 HV 10 . HV 10 50 . 4.2 4.2.1 4.2.2 4.2.3 . . 2 . . 4.2.2 5.1 . , (serration) . 4.2.3 5.2 . 4.3 . . . , . . . . KS P ISO 7151:2008 3 4.4 4.4.1 ( ), , . , , , , . . 4.4.2 1 . a) . b) (satin finish), (matt black finish) c) 1 . , , , ( ). . 2 . , , . 4.4.3 ( ) . 1 30 10 60 10 % . .

6、2 , . 4.5 5.3 . , . 4.6 5.4 . . 5 KS P ISO 7151:2008 4 5.1 5.1.1 5 (CuSO4 5H2O) 4 g (H2SO4) 1.84 g/mL 10 g 90 mL 5.1.2 5.1.3 95 %(V/V) . 5.1.4 6 . . . 5.2 5.2.1 5.2.2 5.2.3 5.2.1 . 5.2.4 5.2.1 , 30 . 1 . 2 . . 5.3 (haemostatic) 2 3 . . 3 . . KS P ISO 7151:2008 5 5.4 3 0.2 mm ( ) . 20 N . . 6 6.1 , .

7、 6.2 . 2 ： mm ( )2 130 3 130 150 4 150 200 ISO 683 13 11 5 200 3 ： mm ( ) 0.8 160 ISO 683 13 11 1 160 KS P ISO 7151:2008 6 KS P ISO 7151： 2008 . 1 . . . 2 ISO 7151, Surgical instruments Non-cutting, articulated instruments General requirements and test methods , ISO 7151 KS A 0001 . 3 . 135513 7017 (02)60094114 (02)600948878 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 7151:2008 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Surgical instrumentsNon-cutting, articulated instrumentsGeneral requirements and test methods ICS 11.040.30