ISO 10993-1:2025

Overview

ISO 10993-1:2025 - Sixth edition - defines the requirements and general principles for the biological evaluation (biocompatibility evaluation) of medical devices within an ISO 14971 risk management process. It applies to devices with direct or indirect contact with a patient’s body during intended use or reasonably foreseeable misuse, and to personal-protection devices used by non-patient users (e.g., gloves, masks). The standard covers assessment across the device life cycle (design, first use, changes, decommissioning) but excludes environmental impacts of decommissioning and evaluation of infectious agents.

Key topics and technical requirements

• Biological evaluation within ISO 14971: Integrates biological safety assessment into the device’s overall risk management process.
• Biological evaluation plan: Documented plan defining scope, data sources, and required assessments.
• Device characterization & hazard identification: Material, component and device-level characterization to identify constituents and tissue‑device interactions.
• Categorization by exposure duration and body contact: Guidance and methods for calculating exposure duration and determining scope of evaluation.
• Biological effects to consider: Includes cytotoxicity, sensitization, irritation, systemic toxicity, local effects after tissue contact, genotoxicity, carcinogenicity, haemocompatibility and other relevant effects.
• Gap analysis and equivalence: Identification of missing data, justification for use of existing data or biological equivalence claims.
• Testing principles: Guidance on when in vitro, ex vivo or in vivo testing is needed; includes degradation testing and toxicokinetic considerations.
• Risk estimation, evaluation and control: Process to estimate biological risk, compare to criteria, and define mitigation measures.
• Documentation & post‑production: Requirements for biological evaluation reports and for production/post‑market activities (including use of post-market data).
• Animal welfare: Considerations for testing that minimize animal use and follow welfare principles.

Practical applications & who uses it

ISO 10993-1:2025 is essential for:

• Medical device manufacturers - design, material selection, pre‑market biological safety.
• Regulatory and compliance teams - dossier preparation, clinical trial prerequisites (biological evaluation is often required before clinical studies).
• Biocompatibility scientists & testing labs - planning testing strategies, interpretation of results.
• Risk managers & clinical safety officers - integrating biological risk into ISO 14971 processes.
• Notified bodies and regulators - assessing conformity and evidence sufficiency.

Typical uses:

• Pre-market assessments of finished devices and prototypes
• Justifying testing exemptions or equivalence
• Supporting change controls and post-market surveillance

Related standards

• ISO 14971 (risk management framework)
• Other parts of the ISO 10993 series (chemical characterization, testing, sample prep)
• ISO 11737-3 (bacterial endotoxins)
• ISO 22442 (materials of animal origin)
• ISO 18562 (breathing-gas pathway devices)
• ISO 7405 (dental devices)

Keywords: ISO 10993-1:2025, biological evaluation, biocompatibility, medical devices, ISO 14971, cytotoxicity, sensitization, haemocompatibility, biological risk assessment.