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 the initial packaging of some special devices, it may be required to be produced or subjected to final cleaning in a production environment with the same cleanliness as sterile medical devices. The cleanliness of the initial packaging of sterile medical devices can be evaluated from the following aspects:
———Particulate contaminants;
——Microbial load;
——Bacterial endotoxins.
T/CAMDI 009.10-2023 history
2024T/CAMDI 009.10-2024 Cleanliness of primary package for sterile medical device Part 10：Limits of contamination
2023T/CAMDI 009.10-2023 Cleanliness of primary package for sterile medical device - Part 10：Limits of contamination
2020T/CAMDI 009.10-2020 Cleanliness of primary package for sterile medical device - Part 10：limits of contamination