To evaluate the virus inactivation effect, whether the animal-based medical devices must be subject to laboratory validation of virus inactivation process？
According to Guidelines for Technical Review of Animal-based Medical Device Registration (2017 Revision), to apply for the registration of animal derived medical devices, the description of the process of inactivating and removing viruses and / or infectious factors in the production process and the effectiveness verification data or relevant materials shall be provided.
The efficacy of virus inactivation can be validated through laboratory validation or from suppliers of animal-derived materials, or evaluated through literature or historical data. If the validation data submitted are not based on the data obtained from the validation of the declared product itself, an analysis and demonstration of its applicability shall be conducted
When conducting EMC test for ultrasonic soft tissue cutting and hemostatic equipment, is it possible to select a type of cutter head as a typical model?
Ordinary ultrasonic cutter head (excluding transducer) only transmits sound energy, not electric energy, which theoretically has no effect on EMC performance. In order to identify the functions of disposable use and collect the working parameters of some ultrasonic cutter heads, there is a chip in the cutter head, which needs power supply and may affect the EMC performance. For the ultrasonic cutter head without chip and without transmitting conductive signal and electric energy, one type of cutter head can be selected for detection.
