GOST R 51088-2013 In vitro diagnostic medical devices Reagents kits the test-systems control materials culture media Requirements to devices and to supporting documentation《体外诊断医疗器.pdf

上传人:postpastor181 文档编号:776643 上传时间:2019-01-23 格式:PDF 页数:24 大小:425.96KB
下载 相关 举报
GOST R 51088-2013 In vitro diagnostic medical devices Reagents kits the test-systems control materials culture media Requirements to devices and to supporting documentation《体外诊断医疗器.pdf_第1页
第1页 / 共24页
GOST R 51088-2013 In vitro diagnostic medical devices Reagents kits the test-systems control materials culture media Requirements to devices and to supporting documentation《体外诊断医疗器.pdf_第2页
第2页 / 共24页
GOST R 51088-2013 In vitro diagnostic medical devices Reagents kits the test-systems control materials culture media Requirements to devices and to supporting documentation《体外诊断医疗器.pdf_第3页
第3页 / 共24页
GOST R 51088-2013 In vitro diagnostic medical devices Reagents kits the test-systems control materials culture media Requirements to devices and to supporting documentation《体外诊断医疗器.pdf_第4页
第4页 / 共24页
GOST R 51088-2013 In vitro diagnostic medical devices Reagents kits the test-systems control materials culture media Requirements to devices and to supporting documentation《体外诊断医疗器.pdf_第5页
第5页 / 共24页
点击查看更多>>
资源描述

1、 51088 2013 , , -, , 2014 510882013 II 1 - . 2 380 - . 3 8 2013. 1483-c 4 5108897 1.02012 ( 8). ( 1 ) , . () . , (gost.ru) , 2014 , 51088 2013 1 , , -, , . In vitro diagnostic medical devices. Reagents, kits, the test - systems, control materials, culture media. Requirements to devices. and to suppo

2、rting documentation 2015 01 01 1 - , - - , , , , -, - - , , . , , 53133.3. , - . , , . ( ). (-, , , , - ). 2 : 1.4 2004 . . 15.013 94 . 51609 2000 . . 52905 2007 ( 15190:2003) . 53133.3 2008 . . 3. 54147 2010 . 12322 2010 in vitro. . 15223-1 2010 . , , . 1. 2.114 - 95 2.601 2006 510882013 2 12.1.005

3、 88 . - ISO 14971 2011 . - , 1 , - , , . -, , - (). -, , , , , . , , , , - . 3 : 3.1 : , - . 1 : ) ; ) , , ; ) ; ) - ; ) , , ) (, , 1 ), . 2 52361, 17. 3.2 : , - , . 3.3 : , , , . ISO 18113-1, 3.49 1. 3.4 : , . 3.5 , , : 1 . 2 ISO 18113-1, 3.24 1. 3.6 : () () () , (, , , -), (- , , ), . 3.7 : , , ,

4、/ , / - , - 510882013 3 , . : 1 . 2 , , , , , , - , . 3 ISO 14971, 2.8. 3.8 : ( ) . : 1 , , . , , . 2 , -. () () . 3 , . 4 , - - (), , , , 2. 3.9 (), : , - , , . 3.10 : , -. : 1 (, , -, ), , . 2 3. 3.11 : , , , - , . 3.12 : , - - - , () , () - , () . : 1 4. 2 -. 3 -, , , - , . 3.13 (): (-), , , ( ), , ( ), - 510882013 4 . , - . : 1 , , , , , , . 2 ISO 18113-1, 3.32 1. 3.14 : , , , : 1 , , , , . 2 , , , - (, , , .). 3 , - . 4 , , -, , , . 5 - , . 6 2. . -. , 2004. 3.15 (): , . : 1 , . 2 ISO 18113-1, 3.5 1. 3.16 : - - , . 3.17 : -

展开阅读全文
相关资源
猜你喜欢
相关搜索

当前位置:首页 > 标准规范 > 国际标准 > GOST

copyright@ 2008-2019 麦多课文库(www.mydoc123.com)网站版权所有
备案/许可证编号:苏ICP备17064731号-1