The IEC 60601-1-8 standard is an auxiliary standard that explains the general specifications, tests and guidelines for electrical medical equipment and warning systems in electrical medical systems, within the scope of the basic safety and performance rules of medical devices. This assurance standard describes the requirements for alarm systems and alarm signals in medical electrical equipment and medical electrical systems. It also provides guidance on the application of alarm systems.
The purpose of the IEC 60601-1-8 standard is to define the basic safety and performance requirements for medical electrical equipment and alarm systems in medical electrical systems, to explain test methods, and to guide their implementation. In this context, alarm categories, degrees of urgency, consistent alarm signals and consistent control states are explained.
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