BIOANALYTICAL STANDARDIZING FOR SEROLOGICAL DIAGNOSTIC MEDICAL DEVICES
A. Yu. Galkin
A. G. Komar
A. A. Grigorenko
- Publisher: National Academy of Sciences of Ukraine and Palladin Institute of Biochemistry of the National Academy of Sciences of Ukraine.
(issn: 2410-7751, eissn: 2410-776X)
in vitro diagnostics | serological methods | analytical methods | standardization | validation | Biotechnology | TP248.13-248.65
In article we analyzed national and international regulations concerning the quality and safety of medical devices for in vitro diagnostics. We discussed the possibility of a partial application of the recommendations of the State Pharmacopoeia of Ukraine to this type o...