GOST ISO 17593-2011 Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy《临床实验室测试和体外医.pdf
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1、 IN VITRO in vitro (ISO 17593:2007, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)ISO 175932011, 1.092 . 1.22009 . , - . , , -, 1 - ()2 3 , (- 402011 29 2011 .) : ( 3166) 00497 ( 3166) 00497 BYKZKGRUTJUZ 4 13 2011 . 1383- ISO 175932011 1 2013 .5 ISO 17593:2007 Clin
2、ical laboratorytesting and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oralanticoagulant therapy ( in vitro. - in vitro -).C (IDT). 175932009. - 6 ( ) - . , - . C, 2013 -, II ISO 1759320111 .12 13 24 64.1 . 64.2 74.3 .74.4 .74.5 74.6 .84.7 85 , 95.1 .95.
3、2 in vitro .95.3 in vitro - 105.4 .115.5 .116 126.1 126.2 126.3 .126.4 .126.5 126.6 .126.7 , .126.8 .126.9 126.10 , 136.11 .136.12 .146.13 147 147.1 147.2 148 158.1 .158.2 .158.3 .158.4 16III ISO 1759320118.5 .208.6 .269 279.1 .279.2 .279.3 .279.4 .279.5 .289.6 289.7 29 A () 30 B () 31 C () .34 D ()
4、 in vitro .35 E () in vitro - 38 F () in vitro .3946 () .48IV ISO 175932011 in vitro, , . . - in vitro - , , ,.- , , , . - , , . -, . , - , - , - , . , 68, 69. , , (, ), -. -, ( - ), , , - () . , , , . , , , ., - , , - , . , in vitro (,IEC 61010, ISO 13485, ISO 14971 ISO 18113), , . , .V ISO 1759320
5、11 IN VITRO in vitro Clinical laboratory testing and in vitro medical devices.Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy1 in vitro - , , - . , K - (). (, , ), .* :- in vitro , K, ;- , - - .2 :ISO 13485:2003 Medical devices Quality management systems R
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