T/CAMDI 009.3-2023 Cleanliness of primary package for sterile medical device – Part 3：Test methods for estimating the total number of microorganisms (English Version)
The initial packaging of sterile medical devices is an integral part of the sterile medical devices, so its cleanliness directly affects the cleanliness of the sterile medical devices. This requires that the initial packaging must be produced under sufficiently clean conditions. For some special devices, the initial packaging may require production or final cleaning in a production environment with the same cleanliness as sterile medical devices.
T/CAMDI 009.3-2023 history
2023T/CAMDI 009.3-2023 Cleanliness of primary package for sterile medical device – Part 3：Test methods for estimating the total number of microorganisms