In the last few years reusable medical devices have gained the spotlight in the medical device industry and regulatory landscape. This attention has forced the standards that govern reusable device validations to update with more clear concise guidelines. The guidance found in AAMI TIR 30 on cleaning validation steps is in the process of being replaced by a new standard AAMI ST98. AAMI TIR12, which offers guidance on which processes are appropriate, was updated at the end of 2020. This webinar will discuss the updates to TIR 12 and the upcoming new standard ST98, and how those changes apply to cleaning, disinfection, and sterilization validations of medical devices.
- Updates to sample size and test control requirements in ST98
- Discussion on the acceptance criteria using statistics for cleaning validations
- Guidance on disinfection level and patient contact in TIR 12