June 7, 2022
With the update to ISO 10993-18, is an extractables study required for all medical devices regardless of contact type and duration of contact? In this article, Helin Räägel, Matthew R Jorgensen, and Thor Rollins from Nelson Labs share insights on...
See BlogFebruary 9, 2022
There is a critical piece of reprocessing validations that has been largely overlooked for a long time: the cleaning chemicals. The devices and instruments used for the validations tend to get most of the attention. Recently Alpa Patel, Principal Scientist...
See BlogNovember 18, 2021
Particulate testing is required for medical devices to ensure patient safety, but there isn’t a lot of guidance available. Here are four important things you need to know about particulate testing on medical devices. First, while there are some device-specific...
See BlogAugust 18, 2021
The ISO 17664 series[1][2] as well as the FDA guidance for reprocessing medical devices in health care settings[3] specify that processing instructions should include the required quality of any water that is used for preparing solutions or for rinsing. A...
See BlogJuly 30, 2021
Deciding which disinfection level applies to your non-critical device can be tricky. Non-critical devices are defined as devices that will either only contact intact skin but do not penetrate it, or which have no direct patient contact but may become...
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