Biocompatibility - Toxicity Testing Procedure | ISO 13485 | FDA QMSR

Plan and document the biological evaluation of a medical device with this editable Biocompatibility and Toxicity Testing Procedure. It addresses device materials, patient contact, existing evidence, biological risks and testing decisions, with sample protocol and final report guidance. The procedure references ISO 10993-1:2025 and ISO 14971:2019.

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Supplied as one editable Microsoft Word document in a digital download.

Biological evaluation planning and evidence review

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.

The biological evaluation begins by characterizing the finished device, its materials, manufacturing residues and the nature and duration of body contact. The team reviews existing data and gaps before choosing evaluation or testing methods. Results are interpreted against biological hazards for each constituent and the finished product, with reassessment if a later design, material or process change alters the exposure picture.

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.

Use this biological evaluation alongside the separately sold Risk Management Procedure for hazard and control records and the Design Verification and Validation Procedure for development evidence. The included sample protocol and final report guide documentation; this product does not provide completed laboratory testing or a device-specific test report.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Medical Device Biological Evaluation: Materials, Contact and Evidence Gaps for workflow guidance, a checklist and common mistakes.