WuXi Medical Device Testing

The upcoming publication of ISO 10993-17 will support the latest ISO 10993 expectations already in place. Gain insights into what this standard will mean to the evaluation process and how to prepare in advance.

Sherry Parker, WuXi AppTec Medical Device Testing

[Image from Pixabay]

Following ISO 10993-1, the lens of medical device biological safety evaluation changed to a risk management process, impacting how manufacturers prepare their medical devices for submission.

The newest version of ISO 10993-17 is approaching publication. These revisions expand current guidance on establishing limits for leachable substances to assess the toxicological risk of medical device chemical constituents. The changes allow for a more consistent evaluation and will likely lead to a more device-specific approach to subsequent biological safety evaluations.

While the ISO 10993-17 guidance document is still in the dra…