Different exposures and mass outcomes require different evidence
- Autoclave / ETO sterilization
Autoclave uses moist heat; ETO uses controlled ethylene oxide gas. Validate each process and the material or assembly response separately.
- Absorbed dose / dose rateThis term
Absorbed dose describes deposited energy per mass, and dose rate describes its change per time. State the radiation and exposure conditions.
- TML / CVCM
TML concerns specimen mass loss during the defined vacuum-heating test. CVCM concerns the fraction collected as condensable material on the controlled collector.
Moist heat and ethylene oxide sterilization use different validated processes. Radiation dose differs from dose rate, while vacuum-heating mass loss differs from collected condensable material.
Conceptual chambers and measurement relationships without process settings or acceptance values. No sterilization compatibility, radiation tolerance or outgassing qualification is implied.