The manufacturer should dynamically evaluate the servicelife of the product through risk analysis in the whole life cycle of theproduct. When there is no unacceptable risk within the service life ofthe product after listing, the expected service life determined beforelisting can be maintained; or the expected service life determinedbefore listing can be extended after reassessment; when the safetyand effective performance of the product after listing is reduced tothe extent that the risk is unacceptable within the service life, therelevant responsible party (manufacturer and/or user) shall assess thisrisk and take corresponding measures.

The following aspects should be considered in the determinationof the service life of active medical devices: key componentssuch as high integrity components, usage frequency and intensitytransportation and storage, usage environment, cleaning, disinfection.sterilization,component maintenance and commercial factors,etc.