October 7, 2022
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...
See BlogSeptember 14, 2022
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...
See BlogSeptember 28, 2021
The FDA guidance on reprocessing medical devices in health care settings: validation methods and labeling states, that when performing cleaning validations, the artificial test soil that is chosen should allow for at least two clinically relevant soil components to be...
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