GOST R ISO 5834-1-2015 Implants for surgery Ultrahigh-molecular-weight polyethylene Part 1 Powder form《外科植入物 超高分子量聚乙烯 第1部分 粉末形式》.pdf

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1、 5834-12015 1ISO 5834-1:2005/Cor.1:2007Implants for surgery Ultra-high-molecular-weight polyethylene Part 1: Powder form(IDT) 1 - ( ) - , 42 422 3 - 20 2015 . 146-4 5834-1:2005 . . 1. (ISO 5834-1:2005 Implants for surgery Ultra-high-molecular-weight polyethylene Part 1: Powderform), ISO 5834-1:2005/

2、Cor. 1:2007. - , 5 1.02012 ( 8). ( 1 ) , . () . , (www.gost.ru) , 2015 , - - II 5834-120151 .12 13 14 , 15 26 27 27.1 .27.2 28 38.1 .38.2 38.3 38.4 .38.5 39 .310 3 () .4III 5834-12015 ( ) ( ). - . -, - , , . , , , . () . , /, 2. . - , , - . 75 % - . , - . - . 5834-1/150, SC 1, . ( 5834-1:1998), . 58

3、34 . :- 1. ;- 2. ;- 3. ;- 4. ;- 5. .IV 5834-12015 1Implantsforsurgery.Ultra-high-molecular-weightpolyethylene.Part1.Powderform 201603011 -(UHMWPE)-.2 . -.-(). 1628-3.- . 3. (ISO 1628-1,Plastics Determination of the viscosityof polymers in diluted solution using capillaryviscometers Part 1:Generalpri

4、nciples) 3451-1 . . 1. (ISO 3541-1,Plastics Determinationofash Part1:Generalmethods) 11542-1.1.(ISO11542-1,Plastics. Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials. Part 1.Designationsystemandbasisforspecifications) 11542-2. 2. (ISO 11542-2,Plastics Ultra-high-mo

5、lecular-weightpolyethylene(PE-UHMW)mouldingandextrusionmaterials Part2:Preparationoftestspecimensanddeterminationofproperties) 53474 , . (Wickbold-Combustion)(DIN53474,Testingofplastics,rubberandelastomers Determinationofthechlorinecontent(Wickbold-Combustion)3 11542-111542-2.4 , 1, 2 3 , -6,7.1.1 5

6、834-12015 5 , . . , , - .6 , . - , 1, - , 1, . 1 . 1 23 Ma 0,2 0,42 8.1 / 2,000 3,200 8.2 - .7 7.1 , 2, , , -, , 2 . 2 , / 1 2 3 125 125 300 8.3 40 40 150 8.4 5 5 50 8.4 30 30 90 8.4 20 20 100 8.4a 3 . , , 3 .7.2 , 8.5, 1 2 25 3 (. 2)(300c17720) .2 5834-120158 UHMWPE-.8.1 11542-2.8.2 1628-3, 0,02 %-

7、 - () 135 C.8.3 3451-1, (700 c17750) C. ( -) , 2.8.4 , 3. 3 DIN 53474 8.5 (75c1775) (400c17710) 1000 . -, . , 5 , , .9 , - . :a) , 7 8;b) 1, 2 3;c) ;d) () .10 , , - , :a) ;b) ;c) ;d) ;e) .3 5834-12015 () .1 - 1628-3 * 3451-1 * 11542-1 * 11542-2 * 53474 * . . - . 678.742:543.813:006.354 11.040 93 9800 : , , 5834-12015 . . . . 14.04.2015. 24.04.2015. 60 c180 8418. . . . 0,93. .-. . 0,70. 34 . . 1802. , 123995 , ., 4.www.gostinfo.ru infogostinfo.ru

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