IEC 60601-1-8 standard prepared by the International Electrotechnical Commission (IEC), an organization affiliated to the International Standards Organization (ISO), within the scope of basic safety and performance rules of medical devices, general specifications for electrical medical equipment and warning systems in electrical medical systems, It is a helpful standard that describes experiments and guidelines.
This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-1-8 Electrical medical equipment - Part 1-8: General rules for basic safety and required performance - Auxiliary standard: eGeneral characteristics, experiments and guidance for warning systems in electrical medical equipment and electrical medical systems.
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 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 conditions are explained.
This standard complements the IEC 60601-1 standard for medical electrical equipment.
The following standards referred to in the implementation of the 60601-1-8 standard are indispensable: IEC 60417-DB (graphic symbols for use in equipment), IEC 60601-1 and IEC 60601-1-1 (medical electrical equipment general safety requirements), IEC 60601- 1-6 (general requirements for medical electrical equipment safety, availability) IEC 60651 (sound level meters) and ISO 3744 (determination of sound power levels using acoustic, sound pressure of noise sources).
Within the scope of medical device tests, tests in accordance with TS EN 60601-1-8 standard are also carried out by our organization.
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