UNE-EN ISO 10993-1:2026

This document specifies requirements and general principles governing the biological evaluation of medical

devices within a risk management process per ISO 14971. This document applies to the evaluation of medical

devices that have direct contact or indirect contact with either:

a patient's body during intended use or reasonably foreseeable misuse; or

the body of other users who are not patients, if the medical device is intended for personal protection (e.g.,

medical gloves, masks).

Biological evaluation assesses the biological safety of the medical device by considering the biological risks

associated with:

constituents of a medical device; and

tissue-device interactions (including physical effects).

The biological evaluation specified by this document can address the biological safety of the medical device

throughout its life cycle from design and development through initial use of the finished medical device to final

decommissioning or withdrawal from use. The evaluation considers both the biological safety of the finished

device in first use, and the significance of any changes to the medical device which can occur throughout the

life cycle. However, the evaluation of risks related to environmental impacts of decommissioning of medical

devices are not within the scope of this document. This version of the standard does not mandate re-testing of

medical devices that are already on the market and have established and acceptable safety profiles (see 6.6.2).

This document can be useful to support clinical or usability evaluations of medical devices. For example, a

biological evaluation is a pre-requisite for conduct of a clinical trial. This means that principles outlined by

this standard can be applied to evaluation of prototype or development stage devices as well as to finished

medical devices.

Other parts of ISO 10993 cover specific aspects of biological evaluation such as chemical characterisation,

biological testing, sample preparations, animal welfare and toxicological risk assessment.

For some types of medical devices, specific requirements from other standards (outside the ISO 10993-series)

can be considered with justification for the approach taken in the event of differences between ISO 10993

requirements and those provided in other standards. For example, the ISO 18562 series of standards

provides specific requirements for biological evaluation of breathing gas pathway medical devices and

ISO 7405 provides specific requirements for biological evaluation of dental devices.

The evaluation of risks related to infectious agents (e.g., bacteria, moulds, yeasts, viruses, transmissible

spongiform encephalopathy (TSE) agents) is not within the scope of this document.

NOTE 1 The evaluation of bacterial endotoxins is addressed by ISO 11737-3.

NOTE 2 Evaluation of risks related to viruses, TSE agents and other pathogens is addressed by the ISO 22442 series,

which provide requirements for risk assessments for materials of animal origin.