GOST R ISO 7198-2013 Cardiovascular implants Tubular vascular prostheses《心血管植入物 管状人造血管》.pdf

1、 7198 2013 - ISO 7198:1998 Cardiovascular implants Tubular vascular prostheses (IDT) 71982013 II 1 - . . ( . . ) , 4 2 3 08 2013 . 1490- 4 7198:1998 - . (ISO 7198:1998 Cardiovascular implants Tubular vascular prostheses). , 5 1.02012 ( 8). ( 1 ) , . () . , (gost.ru) , 2014 , 71982013 III 1 . 1 2 . 1

2、 3 . 2 4 4 5 8 6 in vivo . 10 7 . 12 8 12 9 In vivo 32 () . 37 71982013 1 - Cardiovascular implants Tubular vascular prostheses 20150301 1 1.1 , , , , (), , . , , . . , . , 10993. , . . 1.2 , , , , . , . -, . , . 2 . . ( ). 472:1998 . (ISO 472:1998, Plastics Vocabulary) 2076:1989 . . (ISO 2076:1989,

3、 Textiles Man-made fibres Generic names) 2859-1:1989 . 1. , (ISO 2859-1:1989, Sampling procedures for inspection by attributes Part 1: Sampling plans indexed by acceptable quality level (AQL) for lot-by-lot inspection) 2859-2:1985 . 2. , (ISO 2859-2:1985, Sampling procedures for inspection by attrib

4、utes Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection) 2960:1974 . . (ISO 2960:1974, Textiles Determination of bursting strength and bursting distension Diaphragm method) 71982013 2 5081:1977 . . ( ) (ISO 5081:1977, Textiles Woven fabrics Determination of breaking

5、strength and elongation (Strip method) 5084:1977 . ( ) (ISO 5084:1977, Textiles Determination of thickness of woven and knitted fabrics (other than textile floor coverings) 10993-1:1997 . 1. (ISO 10993-1:1997, Biological evaluation of medical devices Part 1: Evaluation and testing) 14155:1996 (ISO 1

6、4155:1996, Clinical investigation of medical devices) ASTM D 76-93 (ASTM D 76-93, Specification for tensile testing machines for textiles) ASTM D 123-94 , (ASTM D 123-94, Terminology relating to textiles) 3 ASTM D 76-93, ASTM D 123-94, : 3.1 : , . 3.2 : ( ) (). 3.3 : , , (, ). 3.4 : . 3.5 : , , . ;

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