The IEC 60601-1-10 standard, prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Standards Organization (ISO), is a physiological standard to control a physiological variable as part of a physiological closed-loop control system in medical electrical equipment and systems. It describes the analysis, design and verification requirements of the closed-loop controller device, and briefly the criteria for the development of these devices.
This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-1-10 Electrical medical equipment - Part 1-10: Basic Safety and general features for required performance - Auxiliary standard: fFeatures for the development of isiological closed-loop controllers.
The IEC 60601-1-10 standard is an assurance standard that applies to various types of physiological closed-loop control equipment such as linear and nonlinear, adaptive, fuzzy and neural networks. This standard is applied to a closed-loop control equipment that sets the controller output variable to adjust the measured physiological variable by correlating it with the reference variable.
The following standards referenced during the implementation of the IEC 60601-1-10 standard are indispensable: IEC 60601-1 (general requirements for medical electrical equipment, basic safety and basic performance), IEC 60601-1-6 (general requirements for basic safety and basic performance , assurance standard: availability), IEC 60601-1-8 (assurance standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems), IEC 62304 (software life cycle processes) and ISO 14971 (medical risk management application to devices).
Tests in accordance with IEC 60601-1-10 standard are also carried out by our organization within the scope of medical device tests.
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