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.
Status: PublishedPublication date: 2007-11
Edition: 1Number of pages: 71
Technical Committee: ISO/TC 121/SC 3 Respiratory devices and related equipment used for patient care
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|std 1 215||Paper|
|std 2 215|