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SLOVENSKI STANDARD SIST EN IEC 60601221:2021/oprA1:2023 01januar2023Medicinska elektrina oprema 221. del: Posebne zahteve za osnovno varnost in bistvene lastnosti otrokih sevalnih ogrevalnikov Dopolnilo
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Read the user manual for the specific medical electrical equipment.
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Medical electrical equipment refers to devices or apparatus intended for medical purposes that utilize electrical energy to perform specific functions such as diagnosis, monitoring, or treatment of patients.
Manufacturers and regulatory bodies responsible for the oversight of medical devices and equipment are required to file medical electrical equipment.
Filling out medical electrical equipment involves completing the required documentation and forms, providing detailed information about the device's specifications, intended use, and compliance with relevant standards.
The purpose of medical electrical equipment is to aid in the diagnosis, monitoring, treatment, and prevention of medical conditions, ensuring safety and effectiveness in patient care.
Information such as the device's name, model number, manufacturer details, intended purpose, safety data, and compliance with applicable regulations must be reported on medical electrical equipment.
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