ONORM EN ISO 10993-1:2026

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025)

This document specifies the requirements and general principles applicable to the biological evaluation of medical devices within a risk management process according to ISO 14971. This document is applicable to the biological evaluation of medical devices that come into direct or indirect contact with: — the patient's body during intended use or reasonably foreseeable misuse; or — the bodies of other users who are not patients, if the medical device is intended for personal protection (e.g., medical gloves, surgical masks). A biological evaluation assesses the biological safety of a medical device, considering the biological risks associated with: — the components of a medical device; and — the interactions between the product and tissues (including physical effects). The biological evaluation specified in this document can address the biological safety of the medical device throughout its life cycle, from conception and development through initial use of the finished medical device to final decommissioning or cessation of use. Biological evaluation considers both the biological safety of the finished product at first use and the significance of any changes to the medical device that may occur during its life cycle. However, the assessment of risks associated with the environmental impact of decommissioning medical devices is not within the scope of this document. This document does not require re-evaluation of medical devices already on the market with an established and acceptable safety profile (see 6.6.2). This document can be useful in clinical or usability evaluations of medical devices. For example, biological evaluation is a prerequisite for conducting a clinical investigation. This means that the principles set out in this document can be applied to the evaluation of prototypes or products under development as well as to finished medical devices. Other parts of the ISO 10993 series of standards address specific aspects of biological evaluation, such as chemical characterization, biological testing, sample preparation, animal welfare, and toxicological risk assessment. For some types of medical devices, specific requirements from other standards (outside the ISO 10993 series) may be used, provided that the approach taken is justified if there are differences between the requirements of the ISO 10993 series and those in other standards. For example, the ISO 18562 series contains specific requirements for the biological evaluation of medical devices for respiratory gases, and ISO 7405 contains specific requirements for the biological evaluation of dental devices. The assessment of risks associated with infectious agents [e.g., bacteria, molds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents] is not within the scope of this document. NOTE 1: The evaluation of bacterial endotoxins is covered in ISO 11737-3. NOTE 2 The assessment of risks associated with viruses, TSEs and other pathogens originating from materials of animal origin is addressed in the ISO 22442 series of standards.