Biocompatibility - Toxicity Testing Procedure | ISO 13485 | FDA QMSR

The Biocompatibility Procedure governs the biological evaluation of materials and medical devices. The Biocompatibility Procedure is aligned with ISO 10993-1:2025, ISO 14971:2019, MDR 2017/745 and FDA QMSR.

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Biocompatibility Procedure Overview

The Biocompatibility Procedure applies to the biological evaluation of materials and medical devices for use in humans. The Biocompatibility Procedure includes a sample protocol and final report that provides guidance on overall structure and required content.

The revised biological-evaluation content includes ISO 10993-1:2025, ISO 10993-12:2021 with Amendment 1:2025, ISO 10993-17:2023 with Amendment 1:2025, and ISO 10993-18:2020 with Amendment 1:2022.

Regulatory framework

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.