October 7, 2022

Changes Related to Cleaning Validations

The Association for the Advancement of Medical Instrumentation (AAMI) recently released the first cleaning validation standard for medical device manufactures, ANSI/AAMI ST98:2022 Cleaning validation of healthcare products—Requirements for development and validation of a cleaning process for medical devices. This new standard that...

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September 14, 2022

Are You Ready for the New ANSI/AAMI Standard, ST98, Regarding How to Perform Cleaning Validations for Health-Care Products?

Reusable medical devices need to have validated cleaning instructions to ensure patient safety and minimize health-care-acquired infections, corrective actions, recalls, and to ensure compliance with current regulatory standards. For devices that need to comply with US FDA, the requirements regarding...

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