Critical Care Assessment software was developed according to the standards and mathematical procedures for short-term HRV analysis set forth by:
- The European Society of Cardiology
- The North American Society of Pacing and Electrophysiology
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