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ISO 10993

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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October 10, 2023

FDA Guidance 2023 on ISO 10993-1: What Changed?

This article by biocompatibility experts Helin Räägel, PhD, and Audrey Turley discusses the most recent FDA guidance on biological evaluations of medical devices per ISO 10993-1, highlighting the new guidance on intact skin contact. Read Full Article Learn more about...

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September 13, 2023

Complete Rewrite of ISO 10993-1 Creates Industry Buzz

This article by biocompatibility experts Helin Räägel and Thor Rollins discusses the major upcoming revision of ISO 10993-1. Read Full Article Learn more about the authors below.

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January 28, 2022

Understanding Biological Evaluation Plans

According to ISO 10993-1:2018, “the biological evaluation of any material or medical device intended for use in humans shall form part of a structured biological evaluation plan within a risk management process in accordance with ISO 14971.” Based on the...

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