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).
May 11, 2021
By: Lise Vanderkelen and Alpa Patel
Before looking into the validation requirements of thermal disinfection, let’s first go a bit more into what thermal disinfection is...
May 5, 2021
ISO17664:2017 provides guidance on this issue and states that “At least one validated automated cleaning method (which may include a...
April 23, 2021
By: Wendy Mach
On this episode of SPOT radio, Charlie Webb speaks with Wendy Mach with Nelson Labs about their Packaging Validation 101 Webinar....
February 19, 2021
By: Janelle Bentz
ASTM published a new standard called “Standard Specification for Barrier Face Coverings” (ASTM F3502) this week. This standard specification for...
February 18, 2021
By: Sophie Michel and Audrey Turley
The requirements for assessing irritation for medical devices has moved from ISO 10993-10 to ISO 10993-23 and with this new...
