BS EN 62366-1:2015
Medical devices. Application of usability engineering to medical devices

Standard No.
BS EN 62366-1:2015
Release Date
2015
Published By
British Standards Institution (BSI)
Status
Replace By
BS EN 62366-1:2015+A1:2020
Latest
BS EN 62366-1:2015+A1:2020
Replace
BS EN 62366:2008+A1:2015

BS EN 62366-1:2015 Referenced Document

  • EN 1041:2008 Information supplied by the manufacturer of medical devices
  • EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
  • ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
  • ISO 14971:2007 Medical devices - Application of risk management to medical devices
  • ISO 7010:2011 Graphical symbols - Safety colours and safety signs - Registered safety signs
  • ISO 9000:2005 Quality management systems - Fundamentals and vocabulary
  • ISO 9001:2008 Quality management systems - Requirements
  • ISO 9241-11:1998 Ergonomic requirements for office work with visual display terminals (VDTs) - Part 11: Guidance on usability
  • ISO/IEC Guide 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices
  • ISO/TR 16142:2006 Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

BS EN 62366-1:2015 history

  • 1970 BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
  • 0000 BS EN 62366:2008+A1:2015
  • 2015 BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
Medical devices. Application of usability engineering to medical devices



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