ISO 10993-1-2025 PDF

Full title and description

ISO 10993-1:2025 — Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process. This sixth-edition standard defines principles, required outputs and general methods for assessing biological safety of medical devices across the device life cycle, and aligns biological evaluation with the risk-management framework described in ISO 14971.

Abstract

The 2025 revision of ISO 10993-1 updates the core approach to biocompatibility assessment by replacing prescriptive test-checklist methods with a risk- and lifecycle-based process. It emphasizes identification of biological hazards, materials characterization, exposure-duration assessment, scientific justification for test selection, and traceability of hazards through design, manufacturing and use. The standard is intended to support manufacturers, evaluators and regulators in demonstrating the biological safety of medical devices in a consistent, science-based way.

General information

• Status: Published
• Publication date: November 2025
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.100; 11.100.20
• Edition / version: Edition 6 (2025)
• Number of pages: 42

Scope

This part of ISO 10993 specifies requirements and general principles for the biological evaluation of medical devices within a risk management process. It covers identification and assessment of biological hazards arising from device materials and device–tissue interactions, selection and justification of evaluation methods (including chemical characterization and biological testing), and integration of biological evaluation outputs into the broader device risk-management file throughout the product life cycle. It does not cover environmental impacts of device decommissioning.

Key topics and requirements

• Integration of biological evaluation with ISO 14971 risk-management principles and documentation.
• Shift from prescriptive table-based testing to risk-based, scientifically justified test selection.
• Materials characterization requirements including composition, processing aids, residues and degradation products.
• Clear guidance on assessing exposure duration and defining relevant exposure scenarios over the device life cycle.
• Requirement to identify, trace and justify management of biological hazards from raw materials through to finished device.
• Emphasis on minimizing unnecessary testing (including animal tests) through robust chemical and toxicological risk assessment and existing data use.
• New or expanded informational annexes explaining rationale, terminology updates and examples of applying the risk-based approach.
• Requirements for reporting, biological evaluation plans (BEP) and biological evaluation reports (BER) tied to the risk file.

Typical use and users

Primary users are medical device manufacturers, design and regulatory teams, third‑party testing and certification bodies, notified bodies and regulators. The standard is used when planning biocompatibility strategies, preparing BEPs and BERs, selecting tests or justifying omission of tests, and when compiling safety evidence for regulatory submissions (e.g., 510(k), PMA, CE/UK conformity dossiers).

Related standards

ISO 10993-1 is the core of the ISO 10993 series; related documents include other parts of ISO 10993 (for example parts on genotoxicity, cytotoxicity, systemic toxicity, implantation, irritation, material characterization and specific test methods), ISO 14971 (medical device risk management), applicable regional/adopted versions (EN ISO 10993‑1), and regulatory guidance such as the FDA guidance on use of ISO 10993‑1 in premarket submissions.

Keywords

biological evaluation, biocompatibility, medical devices, risk management, ISO 14971, materials characterization, exposure duration, lifecycle assessment, BEP, BER, hazard identification

FAQ

Q: What is this standard?

A: ISO 10993-1:2025 is the sixth edition of the Part 1 standard for biological evaluation of medical devices. It sets out requirements and general principles for evaluating biological safety as part of a risk-management process.

Q: What does it cover?

A: It covers identification and assessment of biological hazards from device materials and interactions with tissue, requirements for materials characterization and exposure assessment, selection and justification of biological tests, and integration of the outcomes into the device risk-management file across the life cycle.

Q: Who typically uses it?

A: Medical device manufacturers, regulatory and clinical affairs teams, testing laboratories, notified bodies, and regulators use the standard to design biocompatibility strategies, prepare supporting documentation and assess biological safety for market submissions.

Q: Is it current or superseded?

A: ISO 10993-1:2025 is the current published edition (Edition 6) and supersedes the previous 2018 edition. Organizations updating biological evaluation processes should refer to the 2025 edition.

Q: Is it part of a series?

A: Yes. ISO 10993-1 is Part 1 of the ISO 10993 series on biological evaluation of medical devices; other parts cover specific endpoints, test methods and guidance that are commonly used alongside Part 1.

Q: What are the key keywords?

A: Biocompatibility, biological evaluation, medical devices, risk-based assessment, materials characterization, exposure duration, lifecycle, ISO 14971, BEP, BER.