GOST R ISO 21535-2013 Non-active surgical implants Joint replacement implants Specific requirements for hip-joint replacement implants《非有源外科植入物 关节置换植入物 髋关节置换植入物的特殊要求》.pdf

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GOST R ISO 21535-2013 Non-active surgical implants Joint replacement implants Specific requirements for hip-joint replacement implants《非有源外科植入物 关节置换植入物 髋关节置换植入物的特殊要求》.pdf_第1页
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GOST R ISO 21535-2013 Non-active surgical implants Joint replacement implants Specific requirements for hip-joint replacement implants《非有源外科植入物 关节置换植入物 髋关节置换植入物的特殊要求》.pdf_第2页
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GOST R ISO 21535-2013 Non-active surgical implants Joint replacement implants Specific requirements for hip-joint replacement implants《非有源外科植入物 关节置换植入物 髋关节置换植入物的特殊要求》.pdf_第3页
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GOST R ISO 21535-2013 Non-active surgical implants Joint replacement implants Specific requirements for hip-joint replacement implants《非有源外科植入物 关节置换植入物 髋关节置换植入物的特殊要求》.pdf_第4页
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GOST R ISO 21535-2013 Non-active surgical implants Joint replacement implants Specific requirements for hip-joint replacement implants《非有源外科植入物 关节置换植入物 髋关节置换植入物的特殊要求》.pdf_第5页
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1、 21535 2013 ISO 21535:2007 Non-active surgical implants Joint replacement implants Specific requirements for hip-joint replacement implants (IDT) 215352013 II 1 ( ) , 4 2 453 3 7 2013 . 86- 4 21535:2007 . . (ISO 21535:2007 Non-active surgical implants Joint replacement implants Specific requirements

2、 for hip-joint replacement implants). , . 5 1.02012 ( 8). ( 1 ) , . () . , (gost.ru) , 2014 , 215352013 III , . ( 1 ): 1: , ; 2: ; 3: . 3 , . 14630 1 . 2 3. 2 , , , , - . , . 215352013 1 Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implant

3、s 20141101 1 . , , , , , , , , . 2 : 7206-1 . . 1. 7206-2 : 1996 . . 2. , 7206-4 . . 4. 7206-6:1992 . . 6. 7206-10 . . 10. 14630 . 21534 : 2007 . . 3 21534 7206-1, : 3.1 , . 3.2 , () , , () , 3.3 , 215352013 2 3.4 , . 3.5 , . 3.6 , . 3.7 , , . 1 , . 2 . 3.8 . , , . . 3.9 , . 4 4 21534 . : 100 /; 60

4、/; 90 / , , . 5 5.1 5 21534 , 5.2 5.3. 5.2 - - , . 5.2.1 , , : , , , , . , , . 5.2.2 , (), 7206-2, 215352013 3 4.1.3 4.2.3 . , , 7206-2. 5.3 5.3.1 42 , , : ) 5 ; ) 6 . 5.3.2 (W) 44 5 . - , , , , 42 , - 44 , . 6 6 21534 . , , . 7 7.1 7 21534 . , , 7.2 21534, : ) ( ); ) , , . . 7.2 7.2.1 , , 7206-4. .

5、 - 7206-4, , 7206-8, , . 7.2.2 7.2 7206-6. 7.2.3 7206-10. 7.2.4 , , , , . 215352013 4 7.2.5 , 4) 21534, , . 8 8 21534 : , - , ; . 4 1200 C. 9 9 14630. 10 10 14630. 11 , 11.1 11 14630 11 21534 . 11.2 , - : ) ; ) (. 7206-1) ( , - / ); ) (. 7206-1) ( , - / ); ) , ( - / ). 11.3 11.3.1 , , , - . 11.3.2 , , , -

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