ivd 产品ce 认证基本要求检查表

appropriate methods of resterilisation or decontamination;Рq) if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and resterilisation or decontamination, and any restriction on the number of reuses;Рr) precautions to be taken as regards exposure, in reasonably foreseeable environmental conditions, to ic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure, acceleration, thermal ignition sources, etc.;Рs) precautions to be taken against any special, unusual risks related to the use or disposal of the device including special protective measures; where the device includes substances of human or animal origin, attention must be drawn to their potential infectious nature;