GOST R ISO 5834-2-2014 Implants for surgery Ultra-high- molecular-weight polyethylene Part 2 Moulded forms《外科植入物 超高分子量聚乙烯 第2部分 模压成型》.pdf

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GOST R ISO 5834-2-2014 Implants for surgery Ultra-high- molecular-weight polyethylene Part 2 Moulded forms《外科植入物 超高分子量聚乙烯 第2部分 模压成型》.pdf_第1页
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1、 5834-2 2014 2 ISO 5834-2:2011 Implants for surgery Ultra-high-molecular-weight polyethylene Part 2: Moulded forms (IDT) 5834-22014 II 1 ( ) , 4 2 453 3 12 2014 . 2073- 4 5834-2:2011 . . 2. (ISO 5834-2:2011 Implants for surgery Ultra-high- molecular-weight polyethylene Part 2: Moulded forms) , A. 5

2、1.02012 ( 8). ( 1 ) , . () . , (gost.ru) 2015 , 5834-22014 1 2 Implants for surgery. Ultra-high- molecular-weight polyethylene. Part 2: Moulded forms 20160101 1 5834-2 , , () . 5834-2 ( , ), , , , , . 2 : 527-1:1993, . . 1. (ISO 527-1:1993 Plastics-Determination of tensile properties-art 1: General

3、principles) 1183-1:1), . . 1. , (ISO 1183-1-:Plastics Methods for determining the density of non-cellular plastics Part 1: Immersion method, liquid pyknometer method and titration method) 3451-1:2008, . . 1. (ISO 3451-1:2008: Plastics Determination of ash Part 1: General methods) 5834-1:2005, . . 1.

4、 (ISO 5834-1:2005: Implants for surgery Ultra-high-molecular-weight polyethylene Part 1: Powder form) 11542-2:1998, . . 2. (ISO 11542-2:1998 Plastics Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials Part 2: Preparation of test specimens and determination of propert

5、ies) 3 , 1-, 2- 3- , 5834-1:2005, 1, 2 3 . 4 5834-1:2005. 5 , , . _ 1) ( 1183-1:2004). (, ) , , . 5834-22014 2 - , . . 6 6.1 , 1, , 1 . , . . 6.2 , 8, . 1 - 1 2 3 /3 927 944 927 944 927 944 7.2 , / 150 150 300 7.3 , , 21 19 19 7.4 , r, 35 27 27 7.5 , r, % 300 300 250 7.6 a, acN, /2180 (126) 90 (73)

6、30 (25) 7.7 - , , . . a , 7.7. , 11542-2 ( ). ASTM F648:2007 ( ). 7 -. , . 7.1 , , 7.2 7.4-7.7, (23 C , 16 . 7.2 ( ), 1183-1, . , 1. 7.3 3451 -1, (700 50) C. , 1. 5834-22014 3 7.4 , t, , 527-1, (100 10) /. (1,5 0,5) . , 1. 7.5 , r, , 7.4. , 1. 7.6 , r, , 7.4. , 1. 7.7 , , acN, , 11542 - 2, B ( ) AST

7、M F648:2007. 8 , . 5834-22014 4 A () A.1 527-1:1993 * 1183-1:2004 * 3451-1: 2008 * 5834-1:2005 * 5834-1:2005 * 11542-2:1998 * * . . . 5834-22014 5 1 11542 2:1998 . . 1. (ISO 11542-2:1998 Plastics Ultra-high-molecular-weight polyethylene (PE- UHMW) moulding and extrusion materials Part 2: Preparation

8、 of test specimens and determination of properties) 2 ASTM F648:2007 (ASTM F648:2007Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants) 3 527-1 . . 1: (ISO 527-1:1993 Plastics; determination of tensile properties; part 1: general prin

9、ciples) 4 1183-1:1). . 1. , (ISO 1183-1-:Plastics Methods for determining the density of non-cellular plastics Part 1: Immersion method, liquid pyknometer method and titration method) 5 3451-1: 2008 . . 1: (ISO 3451-1:2008: Plastics Determination of ash Part 1: General methods) 6 5834-1:2005 . . 1.

10、ISO 5834-1:2005: Implants for surgery Ultra-high-molecular-weight polyethylene Part 1: Powder form) 7 5834-1:2007 . . 1. (ISO 5834-1:2007: Implants for surgery Ultra-high-molecular-weight polyethylene Part 1: Powder form) 5834-22014 616-089.844:006.354 11.040.40 : , , , , , 02.02.2015. 60x841/8. . . . 0,93. 32 . . 837. , 123995 , ., 4. www.gostinfo.ru infogostinfo.ru

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