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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…

xpert toxicologist identifying the substances of potential significance present at medical laboratory adhering to the toxicological risk assessment process in ISO 10993-17:2023.
ANSI | Medical Devices

ISO 10993-17:2023— Toxicological Risk Assessment

ByAlexandra Schirn October 9, 2023June 10, 2025

Risk assessment is a multi-step process which produces estimates of risk of an adverse health effect occurring as a consequence of ingesting, inhaling, and/or absorbing…

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