ISO 10993-1:2018

Overview

ISO 10993-1:2018 - "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" is the international framework for assessing biocompatibility and biological safety of medical devices. It defines general principles for biological evaluation within a risk management process, classifies devices by the nature and duration of body contact, and describes how to evaluate existing data, identify data gaps, and select additional data and tests needed to assess biological risk. The standard applies to all device types (active/non‑active, implantable/non‑implantable) and also covers devices intended to protect the user (e.g., gloves, masks). Note: hazards from pathogens (bacteria, viruses, TSEs) are excluded.

Key topics and technical requirements

• Risk‑based biological evaluation: Integrate biological assessment into the device’s overall risk management (aligned with ISO 14971).
• Device categorization: Classify by nature of contact (non‑contacting, surface‑contacting, externally communicating, implant) and duration of contact (transitory, short, long, permanent).
• Data review and gap analysis: Systematically evaluate all available sources (literature, supplier data, previous testing) and identify missing information based on risk analysis.
• Selection of biological endpoints: Determine relevant endpoints (e.g., cytotoxicity, sensitization, systemic toxicity) and prioritize testing based on exposure and device category.
• Physical/chemical characterization: Use material and chemical data to inform biological risk (see ISO 10993‑18).
• Testing strategy and interpretation: Combine in vitro, in vivo, and chemical characterization as needed; interpret results in context of device use and patient exposure.
• Annex guidance: Informative Annex A lists endpoints; Annex B explains how to conduct evaluation within risk management; Annex C suggests literature review procedures.

Practical applications - who uses this standard

• Medical device manufacturers: plan biocompatibility programs, select tests, compile regulatory submissions.
• Regulatory affairs and quality teams: justify biological safety strategy during premarket review and audits.
• Biocompatibility engineers and testing labs: design test plans and interpret test results within a risk context.
• Notified bodies and auditors: evaluate conformity of biological evaluation and risk management.
• R&D and materials selection: choose materials and assess changes (e.g., degradation, breakage) for biological impact.

Related standards

• ISO 10993 series (e.g., ISO 10993‑5 cytotoxicity, ISO 10993‑11 systemic toxicity, ISO 10993‑18 chemical characterization)
• ISO 14971 (application of risk management to medical devices)

ISO 10993-1:2018 is essential for anyone involved in biocompatibility testing, medical device safety, and regulatory compliance - enabling a structured, risk‑based approach to biological evaluation and documentation.