ANSI/AAMI ST98 provides cleaning validation requirements for device manufacturers

Editor's Note

The Association for the Advancement of Medical Instrumentation (AAMI) on August 24 announced the publication of a new standard: “ANSI/AAMI ST98:2022, Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices.”

The new standard not only provides manufacturers with a formalized cleaning validation methodology that advances understanding of and conformance with cleaning best practices, but it has the potential to impact device design and development in the future, according to AAMI.