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[DOI] [PMC free article] [PubMed] [Google Scholar] 6.Vecchio M., Malaguarnera G., Giordano M., Malaguarnera M., Li Volti G., Galvano F., Drago F., Basile F., Malaguarnera M

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Heart Failure -Introduction, Classification, and Universal Definition 1

5 Class 1 No public health risk Low personal risk Sample collection containers Microbiological culture media Class 2 Low public health risk Moderate personal risk Pregnancy and fertility self-testing kits Cholesterol tests Class 3 Moderate public health risk High personal risk Tests to detect a sexually transmitted disease (e.g., chlamydia, gonorrhea) Human genetic tests Class 4 High public health risk HIV screening tests Ebola tests A conformity assessment involves the examination of clinical data, design records, quality processes, and technical documentation to determine if the device performs as intended and conforms to TGAs Essential Principles