IEC 60601-1-8/FRAGf ED1

Medical electrical equipment - Part 1-8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601-1-8/FRAGf ED1

Scope

Specifies requirements for alarm systems and alarm signals in medical electrical equipment and medical electrical systems.
It also provides guidance for the application of alarm systems.

The object of this collateral standard is to specify basic safety and essential performance requirements and tests for alarm systems in medical electrical equipment and medical electrical systems and to provide guidance for their application. This is accomplished by defining alarm categories (priorities) by degree of urgency, consistent alarm signals and consistent control states and their marking for all alarm systems.