New Requirements for Medical Device Cleaning Validations: An Overview of ST98

As medical devices become more advanced and innovative, so do the regulations that surround them. This includes guidance for cleaning validations. Historically, AAMI TIR30 and other similar documents have offered guidance for this process 1 ; however, the creation of AAMI ST98 offers a standard for cleaning validations. Where AAMI TIR30:2011 states what considerations should be made during a cleaning validation, AAMI ST98 provides more details on those considerations, including, but not limited to, validation of extraction methods, extraction efficiency requirements, TOC acceptance criteria, and justification of sample size.