February 23,2012
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The EU in vitro diagnostic medical device laws and regulations related to the coordination of standards in Europe

EN 455-1
  Disposable medical gloves - Part 1: Requirements and test non-porous
   
 
EN 928
  In vitro diagnostic systems - the in vitro diagnostic medical devices in vitro diagnostic EN 29001, EN 46001, EN 29002 and EN 46002 standard application guide
   
 
EN 980/A1
  In vitro diagnostic medical devices for the graphic symbols label
   
 
EN 1658
  A sign of in vitro diagnostic equipment requirements
   
 
EN ISO 9360-1
  For moist respiratory gases in patients with wet heat exchangers (HMEs) - Part 1: The lowest gas heat exchanger for 250ml of the wet (ISO 9360-1:2000)
   
 
EN ISO 10993-15
  Biological evaluation of medical devices - Part 15: Metal and Alloy Modification to identify and quantify materials (ISO 10993-15:2000)
   
 
EN 12286
  In vitro diagnostic in vitro diagnostic medical devices - measurement of the number of biological samples - a reference to measure the procedure introduced
   
 
EN 12286/A1
  In vitro diagnostic in vitro diagnostic medical devices - the number of samples of biological sources of measurement - reference measurement procedures for demonstration
   
 
EN 12287
  In vitro diagnostic in vitro diagnostic medical devices - the number of samples of biological sources of measurement - reference material described in
   
 
EN 12322
  In vitro diagnostic in vitro diagnostic medical devices - Microbiological medium - medium performance standards
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