This document specifies the contamination limit requirements for the cleanliness test of the primary packaging and/or primary packaging materials of sterile medical devices in accordance with the T/CAMDI 009 series of standards. This document is applicable to manufacturers of primary packaging and/or primary packaging materials for sterile medical devices, as well as manufacturers of sterile medical devices.
T/CAMDI 009.10-2024 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