GOST ISO 8615-2012 Implants for surgery Fixation devices for use in the ends of the femur in adults Technical requirements《外科植入物 成人股骨端固定装置 技术要求》.pdf

1、 , () INTERSTATE COUNCIL FOR STANDARTIZATION, METROLOGY AND CERTIFICATION (ISC) , (ISO 8615:1991, IDT) 2013 ISO 8615 2012 ISO 8615 2012 II , 1.092 -. 1.22009 -. , . , , , . 1 - - - () 2 () 3 , - ( 41-2012 24 2012 .) : - ( 3166) 004-97 ( 3166) 004-97 AZ AM BY KZ KG MD - RU TJ UZ UA 4 19 2012 . 1935-

2、ISO 86152012 1 2015 . 5 ISO 8615:1991 Implants for surgery. Fixation devices for use in the ends of the femur in adults. Technical require- ISO 8615 2012 IIIments ( . , . ). (IDT). - . 861599 6 ( ) - . - , -. - C, 2013 - , ISO 8615 2012 V ISO 8615:1991 . , . , - 5 150 . , - , , , . - - . , - . - , ,

3、 , , -, . ISO 8615 2012 1 , - Implants for surgery. Fixation devices for use in the ends of the femur in adults. Technical requirements 2015-01-01 1 , , , , - , . -: a) ; b) - ; c) - ; d) - . . 1 7 -, . ISO 8615 2012 2 2 : ISO 5835:1991 Implants for surgery. Metal bone screws with hexagonal drive co

4、nnec-tion, spherical under-surface of head, asymmetrical thread; dimensions. ( -. - ) ISO 261:1973 ISO general purpose metric screw threads. General plan. ( - ISO . ) ISO 272:1982 Fasteners. Hexagon products. Widths across flats ( . ) ISO 965-2:1980 ISO general purpose metric screw threads. Toleranc

5、es. Part 2. Limits of sizes for general purpose bolt and nut threads. Medium quality. ( ISO - . . 2. . ) ISO 5832-1:1987 Implants for surgery; metallic materials. Part 1. Wrought stainless steel ( . . 1. -) ISO 5832-2:1978 Implants for surgery; Metallic materials. Part 2. Unalloyed titanium ( . . 2.

6、 ) ISO 5832-3:1990 Implants for surgery; metallic materials. Part 3. Wrought titanium 6-aluminium 4-vanadium alloy ( . . 3. , (6 %) (4 %) ISO 5832-4:1978 Implants for surgery. Metallic materials. Part . Cobalt-chromium-molybdenum casting alloy ( . . 4. , ) ISO 5832-5:1978 Implants for surgery. Metal

7、lic materials. Part 5. Wrought cobalt-chromium-tungsten- nickel alloy ( . . 5. , , -) ISO 5832-6:1980 Implants for surgery. Metallic materials. Part 6. Wrought cobalt-nickel-chromium- molybdenum alloy ( . . 6. , , -) ISO 8615 2012 3ISO 5832-7:1984 Implants for surgery. Metallic materials. Part 7. Fo

8、rgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy ( . - . 7. , , , ) ISO 5832-8:1987 Implants for surgery; metallic materials. Part 8. Wrought cobalt-nickel-chromium- molybdenum-tungsten-iron alloy ( . -. 8. , , , , ) ISO 5836:1988 Implants for surgery. Metal bone plates. Holes co

9、rresponding to screws with asymmetrical thread and spherical under-surface ( . - . - ) ISO 6018:1987 Orthopaedic implants. General requirements for marking, packaging and labelling ( . , -) ISO 9268:1988 Implants for surgery. Metal bone screws with conical under-surface of head. Dimensions ( . - . )

10、 ISO 9269:1988 Implants for surgery. Metal bone plates. Holes and slots corresponding to screws with conical under-surface ( . ) 3 3.1 ISO 5832, 18. 3.2 -. - . . - 66 ( 66) - . 4 : ISO 8615 2012 4 ; , - ; , - -. . 5 5.1 5.1.1 , 1. 5.1.2 , 1 7. - . 5.2 5.2.1 16 , - 6,5 ( b d 1 2). 5.2.2 , - 1 7, 13 .

11、 - , . , - - . ISO 8615 2012 5() d b -(. 1 2) -(-, V-) () -()() -(, ) () -()() -/ -(-) -/ -/ -1 , -, -1 . 2 1 7.3 . ISO 8615 2012 6 5.3 50 150 . -, 5 . 5.4 5.4.1 , , : a) 2,8 2,80 ; b) 2,2 2,20 ; c) 2,0 2,00 . 2,8 - 2,5 ; 2,2 1,6 2,00 ; 2,0 1,5 . 5.4.2 - 2. 2 - , 2,0 2,8 1,00 0,79 0,79 1,00 1,35 0,79 0,79 1,29 5.5 5.5.1 8 . 5.5.2 20 . 5.5.3 6, 8 1, 7, 10 1 ISO 261, 6H/6g ISO 965-2. 5.6 5.6.1