IVDD协调标准清单（医疗器械CE认证资料） _ 工业工程网

</script>Standard         Titles

• EN 375: 2001        Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
  
• EN 376: 2002        Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
  
• EN 591: 2001        Instructions for use in vitro diagnostic instruments for professional use
  
• EN 592: 2002        Instructions for use for in vitro diagnostic instruments for self-testing
  
• EN 928: 1995         In vitro diagnostic systems – Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices
  
• EN 980: 1996/ A2:2001        Graphical symbols for use in the labelling of medical devices
  
• EN 1658: 1996         Requirements for marking of in vitro diagnostic instruments
  
• EN 12286: 1998/ A1:2000        In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Presentation of reference measurement procedures
  
• EN 12287: 1999         In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Description of reference materials
  
• EN 12322: 1999/ A1:2001        In vitro diagnostic medical devices – Culture media for microbiology – Performance criteria for culture media
  
• EN 13532: 2002        General requirements for in vitro diagnostic medical devices for self-testing
  
• EN 13612: 2002        Performance evaluation of in vitro diagnostic medical devices
  
• EN 13640: 2002        Stability testing of in vitro diagnostic medical devices
  
• EN 13641: 2002        Elimination or reduction of risk of infection related to in vitro diagnostic reagents
  
• EN 13975:2003        Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
  
• EN ISO 14971:        Medical devices – Application of risk management to medical devices (ISO 14971:2000)
  
• 2000
  
• EN ISO 18153:2003        In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)
  
• EN 61010-2-101: 2002        Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
  
•         Reference document: IEC 61010-2-101:2002 (Modified)</ul>
  

pmp148 (2006-8-03 02:05:58)哈哈学习
多谢分享pmp148 (2006-8-29 00:22:56)出口认证--开拓国际市场的通行证！
您好
我专门负责医疗器械出口认证
包括CE、ISO13485、FDA等出口认证
贵公司产品出口需要做认证可以联系我
有机会交流交流
希望可以为您的产品出口提供“通行证”！hua0530 (2007-4-18 11:46:38)tttttttttttttttttttttttttttttttt

[ 本帖最后由 hua0530 于 2007-7-13 17:42 编辑 ]sc623 (2007-6-08 15:40:45):) 出口认证--开拓国际市场的通行证！
xo p%P*J,zsrL您好
%o}4[)u3jd        x~5Y.`我专门负责医疗器械出口认证
5r jy2U2c包括CE、ISO13485、FDA等出口认证^f"#
qv+wce
贵公司产品出口需要做认证可以联系我-质量-SPC ,six sigma,TS16949,MSA,FMEA8^'AF0Jo[,^
有机会交流交流
"O-c3K3Y#O3{.F希望可以为您的产品出口提供“通行证”！bztest (2007-8-29 09:22:09)争创认证领域的第一品牌
MSN:renzheng166#hotmail.com
T:021-61134006 || www.bztest.cn
专注CE  服务中国 || 权威认证  值得信赖mantail (2007-8-29 14:53:26)做医疗器械的多交流

顶上去

楼上你为何这么吊

谢谢楼主，共同发展

我在论坛打滚这么多年，所谓阅人无数，就算没有见过猪走路，也总明白猪肉是啥味道的。

支持下 很好的资料

学习了，谢谢分享

我想加入 QQ群

我是来刷分的，嘿嘿

大爱工业工程

工业工程值得分享