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Female scientist overseeing ISO 10993-1:2025 biological evaluation process for medical devices, highlighting safety, biocompatibility, and risk management steps.
ANSI | Medical Devices

ISO 10993-1:2025—Biological Evaluation of Medical Devices

ByAlexandra Schirn January 13, 2026January 2, 2026

Medical devices range from simple bandages to complex implantable devices like pacemakers and prosthetics. Regardless of their complexity, all medical devices must undergo rigorous testing…

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