Written by our experts, our blog provides updates on regulatory issues, upcoming changes to compendial test standards, and information about our participation with standard writing committees and organizations (AAMI, ASTM, AATB, ISO).
February 9, 2022
By: Alpa Patel
There is a critical piece of reprocessing validations that has been largely overlooked for a long time: the cleaning chemicals....
January 28, 2022
By: Brent Terry
According to ISO 10993-1:2018, “the biological evaluation of any material or medical device intended for use in humans shall form...
December 7, 2021
By: Lise Vanderkelen and Alpa Patel
Understanding the sterility assurance level To understand how steam sterilization processes are validated, it is important to understand some key...
November 30, 2021
ISO 17664:2017[1] as well as FDA[2] state that if a medical device is intended to be sterilized, at least one...
November 18, 2021
By: Jennifer Gygi and Maria Thomas
Particulate testing is required for medical devices to ensure patient safety, but there isn’t a lot of guidance available. Here...
