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Biocompatibility Testing

March 12, 2025

Applying the Appropriate Extraction Conditions for Biocompatibility Testing

Sample representativeness and quantity determination for test articles have been discussed in my previous posts. Continuing on the topic of what to consider when performing biological testing, this post will cover the extraction conditions to be applied for testing. Extraction...

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February 20, 2025

Reviewing a Tech Talk from MD&M West 2025: Key Updates to the New Revision of ISO 10993-1

At this year’s MD&M West trade show, Nicholas Christiano, Global Segment Leader for Biological Safety at Nelson Laboratories, presented on updates to the new revision of ISO 10993-1, the cornerstone standard guiding biocompatibility assessments for medical devices.      ...

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November 11, 2024

Determining the Quantity of Samples for Biocompatibility Testing

In my previous blog post I discussed sample representativeness and provided recommendations on how test articles should be prepared, outlining details that may be overlooked in the process. With various considerations that need to be accounted for, it is difficult...

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April 13, 2023

Nelson Labs is an ASCA Accredited Testing Laboratory!

Nelson Labs has recently received ASCA accreditation for Biocompatibility, specifically cytotoxicity and sample preparation (ID TL-65). The Accreditation Scheme for Conformity Assessment (ASCA) is offered through the FDA CDRH Standards and Conformity Assessment Program (S-CAP). The goals of the ASCA...

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April 7, 2022

Biocompatibility Fundamentals for Medical Devices eBook

This eBook contains guidelines for planning, risk mitigation, testing, and compliance for the design and manufacture of medical devices. It provides a digest of pressing challenges and solutions for medical-device design, development, and testing with regard to biocompatibility and toxicology...

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