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KINGDOM OF SAUDI ARABIA SAUDI STANDARDS, METROLOGY AND QUALITY ORGANIZATION SAS SAUDI STANDARD DRAFT No19981 /2011 MEDICAL ELECTRICAL EQUIPMENT Part 12: General requirements for basic safety and essential
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Medical electrical equipment parts are components or accessories that are essential for the functioning of medical devices.
Manufacturers or distributors of medical electrical equipment parts are required to file with the appropriate regulatory authorities.
To fill out a medical electrical equipment part, manufacturers or distributors need to provide detailed information about the component or accessory, including but not limited to its specifications, intended use, and testing results.
The purpose of filing a medical electrical equipment part is to ensure the safety and effectiveness of medical devices that rely on these components or accessories.
Information that must be reported on a medical electrical equipment part includes technical specifications, intended use, testing results, and any known risks or hazards associated with the component or accessory.
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