CEI EN 60601-1-10/A2 PDF

This collateral standard specifies requirements for the development (analysis, design, VERIFICATION and VALIDATION) of a PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) as part of a PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM (PCLCS) to control at least one PATIENT VARIABLE (i.e. a PHYSIOLOGIC VARIABLE) in ME EQUIPMENT and ME SYSTEMS.

EXAMPLE A PATIENT VARIABLE can be a measure of body chemistry (e.g. electrolytes or blood glucose value), a physical property (e.g. body temperature, electrophysiologic characteristic, hemodynamic quantity), or a pharmaceutical concentration.