YY/T 9706.110-2021 Medical electrical equipment—Part 1-10:General requirements for basic safety and essential performance—Collateral Standard: Requirements for the development of physiologic closed-loop controllers

Scope

This part of YY/T 9706 specifies the development (analysis, design, verification, and validation) requirements for physiological closed-loop controllers (PCLCs) used in medical electrical equipment and medical electrical systems (hereinafter referred to as ME equipment and ME systems) to control physiological variables as part of a physiological closed-loop control system (PCLCS).
Note: Physiological variables may include human body chemistry (such as electrolytes, blood sugar), physical characteristics (such as patient body temperature, electrophysiological phenomena, hemodynamics), or drug concentrations.
This part applies to the basic safety and basic performance of ME equipment and ME systems.
This part applies to various types of PCLCs, such as linear and non-linear, adaptive, fuzzy, and neural network ones.
The content of this part does not include:
——Additional mechanical requirements; or
——Additional electrical requirements.
This part applies to closed-loop controllers (see Figure 1), which adjust (i.e., change or maintain) measured physiological variables by setting the controller output variables and associating them with reference variables.
This part does not apply to closed-loop controllers that use feedback data obtained from non-patient measurements to maintain physical or chemical variables.
Note: The chapters and articles marked with an asterisk (*) in this part have relevant principle explanations in Appendix A.

Development Information

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