Standard Compliance

pt_bg_3qjhStandard Compliance

Critical Care Assessment software was developed according to the standards and mathematical procedures for short-term HRV analysis set forth by:

Critical Care Assessment is FDA 510k cleared.

Critical Care Assessment is also in compliance with the following standards:

  • ISO 13485:2003
  • ISO 9001:2008
  • EN 60601-1:1990
  • EN 60601-1-1:2001
  • EN 60601-1-2:2001
  • ANSI-AAMI EC57-98
  • ANSI-AAMI EC13:2002
  • EMC, Directive 93/42/EEC
  • CE 0120