WinSystems Life Support Policy
WINSYSTEMS' PRODUCTS ARE NOT AUTHORIZED FOR USE AS CRITICAL COMPONENTS IN LIFE SUPPORT
DEVICES OR SYSTEMS WITHOUT THE EXPRESS WRITTEN APPROVAL OF THE PRESIDENT
OF WINSYSTEMS CORPORATION. As used herein.
1. Life support devices or systems are devices or systems which, (a) are intended
for surgical implant into the body, or (b) support or sustain life, and whose
failure to perform, when properly used in accordance with instructions for use
provided in the labeling, can be reasonably expected to result in a significant
injury to the user.
2. A critical component is any component of a life support device or system whose
failure to perform can be reasonably expected to cause the failure of the life
support device or system, or to affect its safety or effectiveness.