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 : , , . ;
7、/ / . 3.6 : . 3.7 : , , , . 3.8 : , / ( 3.9). , , , . 3.9 : , ( 3.8). 3.10 : , . , , . 3.11 : . , , , . 3.12 : . 3.13 : , . 71982013 33.14 : , . 3.15 : , , , / . (. 3.20), . 3.16 : ( , ), . 3.17 : ( , ), . , , . 3.18 : , . 3.19 : , , . 1 , , . 2 , (. 3.17) (. 3.34). 3.20 : , . 3.21 : , , . 3.22 : ,
8、. 3.23 : , , . 3.24 : , , . 3.25 : , , 3.5. 3.26 : , / . , , , , . 3.27 : , . , , . 3.28 : , . , , , . 3.29 : , , . . 3.30 , : , , . 3.31 : . 3.32 : , ( 3.19). 71982013 4 , . 3.33 : , . 3.34 , : , . 1 -2-1 16 (120 . .). 2 , (. 3.19). 3.35 , : , , . 4 , . 4.1 , , , . , , - . , . 4.1.1 : a) , ; b) , , 16 (120 . .), 10 % (. 5.6); c) , . 4.1.2
