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IEC 60601-1-10 Ed. 1.2:2020 (b)
医用電気機器-第1-10部:基礎安全及び基本性能に関する一般要求事項-副通則:生理的閉ループ制御器の開発に関する要求事項
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

発行年月日: 2020-07-22
状態: 有効
邦訳版: 無

規格概要
IEC 60601-1-10:2007+A1:2013+A2:2020 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) in medical electrical equipment and medical electrical systems to control a physiologic variable. This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks. This collateral standard applies to a closed-loop controller 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. This consolidated version consists of the first edition (2007), its amendment 1 (2013) and its amendment 2 (2020). Therefore, no need to order amendments in addition to this publication.
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TC TC 62/SC 62A
ICS 11.040.01
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