EVS-EN 60601-1-10:2008+A1+A2:2021

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT
and ME SYSTEMS.
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.
This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive,
fuzzy, neural networks.
This collateral standard does not specify:
− additional mechanical requirements; or
− additional electrical requirements.
This collateral standard applies to a closed-loop controller (see Figure 1) that sets the
CONTROLLER OUTPUT VARIABLE in order to adjust (i.e., change or maintain) the measured
PHYSIOLOGIC VARIABLE by relating it to the REFERENCE VARIABLE.
A closed-loop controller that maintains a physical or chemical VARIABLE, using feedback that is
not measured from a PATIENT, is outside the scope of this standard.