Labelling of medical devices

The requirements for information to be supplied with medical devices are addressed by the following standards: 

  • BS EN 375 Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
  • BS EN 376 Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
  • BS EN 591 Instructions for use for in vitro diagnostic instruments for professional use
  • BS EN 592 Instructions for use for in vitro diagnostic instruments for self-testing
  • BS EN 1041 Information supplied by the manufacturer with medical devices

 Also available:

  • BS EN 980:2008 Graphical symbols for use in the labelling of medical devices
  • BS EN 980 Symbols for labelling medical devices is available on CD BS EN 980:2008 Symbols for labelling medical devices is available on CD
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