T/CAMDI 009.10-2023 Active
T/CAMDI 009.10-2023 Sterile Medical Device Initial Packaging Cleanliness - Part 10: Limit of Contamination
Abstract
Main technical content: The primary packaging of sterile medical devices is an integral part of sterile medical devices, so its cleanliness directly affects the cleanliness of sterile medical devices. This requires that the primary packaging be produced under sufficiently clean conditions. For the primary packaging of certain special devices, it may be required to be produced in a production environment with the same cleanliness as that of sterile medical devices, or to undergo final cleaning. The cleanliness of the primary packaging of sterile medical devices can be evaluated from the following aspects: — Particle contaminants; — Microbial load; — Bacterial endotoxins
General Product Information
| Document Type | Group standards |
|---|---|
| Standard Status | Active |
| Standard Code | T/CAMDI 009.10-2023 |
| ICS | Disinfection and packaging |
| Implement Date | 2023-04-20 |