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Medical Devices

December 11, 2023

Extraction of Medical Devices for Bacterial Endotoxin Testing

 When performing the Bacterial Endotoxin test, we observe changes within a solution that occur as a reaction to the presence of endotoxin. As such, it is necessary that the test medium be a liquid. For pharmaceutical products, the sample is...

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June 13, 2023

How to perform cleaning validations for semi-critical and critical devices according to the new ANSI/AAMI ST98 standard?

Cleaning validation requirements for reusable medical devices according to AAMI TIR30 did not distinguish between non-critical devices on the one hand and semi-critical or critical devices on the other. Additionally, many validation testing requirements were formulated using generalities rather than...

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May 30, 2023

How to Perform Cleaning Validations for Non-Critical Devices According to the New ANSI/AAMI ST98 Standard

Cleaning validation requirements for reusable medical devices according to AAMI TIR30 did not distinguish between non-critical devices on the one hand and semi-critical or critical devices on the other. Only general recommendations were formulated, which resulted in one validation approach...

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June 7, 2022

A Haystack with No Needle: Is an Extractables Study Appropriate for Limited-Contact Devices?

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...

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February 9, 2022

What About the Chemicals Used in Reprocessing Reusable Medical Devices?

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...

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