Standard Number: YY/T 9706.110-2021(YY/T9706.110-2021)
Chinese:医用电气设备 第1-10部分：基本安全和基本性能的通用要求 并列标准：生理闭环控制器开发要求
English:Medical electrical equipment – Part 1-10: General requirements forbasic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
Effective Date:2023-05-01
ICS:11.040.01
Standard Applicability:This standard specifies the requirements for the development (analysis, design, verification and validation) of physiological closed-loop controllers (PCLCs) used to control physiological variables as part of a physiological closed-loop control system (PCLCS) in medical electrical equipment and medical electrical systems. This standard applies to various types of PCLCs such as linear and nonlinear, adaptive, fuzzy, neural networks, etc. The content of this standard does not include: additional mechanical requirements; or additional electrical requirements. This standard applies to closed-loop controllers that modulate (i.e., change or maintain) measured physiologic variables by setting controller output variables and correlating them with reference variables. This standard does not apply to closed-loop controllers that use feedback data not derived from patient measurements to maintain physical or chemical variables.
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