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Recommend use of ECRI s Universal Medical Device Nomenclature System UMDNS. Adapted from Information Security for Biomedical Technology A HIPAA Compliance Guide ACCE/ECRI 2004. This form was adapted from portions of the ACCE/ECRI Biomedical Equipment Survey Form a key tool found in Information Security for Biomedical Technology A HIPAA Compliance Guide ACCE/ECRI 2004. HIMSS recommends that the information in the MDS2 be used to help complete the ACCE/ECRI form and associated processes as part...
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Device category is a classification system used to categorize different types of devices based on their characteristics and intended use.
Manufacturers, distributors, and importers of devices are required to file device category.
Device category can be filled out by providing detailed information about the device, its intended use, and any relevant specifications.
The purpose of device category is to help regulators and consumers understand the characteristics and intended use of different devices.
Information such as device name, model number, intended use, specifications, and any relevant warnings or precautions must be reported on device category.
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