ISO 10993-3:2026 Published for Biological Evaluation of Medical Devices

ISO 10993-3:2026 has been published as part of the internationally recognised ISO 10993 series for the biological evaluation of medical devices.

The standard focuses on the evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity, supporting manufacturers in assessing potential long-term biological risks associated with medical devices and their constituent materials.

Scope of ISO 10993-3:2026

ISO 10993-3:2026 addresses four critical toxicological endpoints:

• genotoxicity;

• carcinogenicity;

• reproductive toxicity;

• developmental toxicity.

These endpoints are particularly relevant where biological evaluation identifies potential concerns related to device materials, chemical constituents, degradation products or long-term patient exposure.

Replacement of the Previous Edition

The publication indicates that ISO 10993-3:2026 replaces the previous ISO 10993-3:2014 edition.

The updated version reflects the latest scientific knowledge and current regulatory expectations for biological safety evaluation.

Importance for Biocompatibility Strategies

For medical device manufacturers, ISO 10993-3:2026 is relevant because biological evaluation is increasingly expected to follow a risk-based and science-based approach.

The updated standard supports the assessment of potential long-term biological hazards and should be considered alongside other elements of a complete biological evaluation strategy, including chemical characterisation and toxicological risk assessment.

Relevance for Implantable and Long-Term Contact Devices

The update is especially important for manufacturers developing devices with prolonged or repeated contact with the body, including implantable devices and products made from materials requiring detailed toxicological assessment.

Early consideration of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity can help manufacturers reduce regulatory uncertainty and avoid delays during conformity assessment or market access review.

Impact on Medical Device Manufacturers

Manufacturers should pay particular attention to:

• integration of ISO 10993-3:2026 into biological evaluation plans;

• identification of potential long-term toxicological risks;

• alignment with ISO 10993 chemical characterisation and toxicological risk assessment principles;

• justification of testing strategies;

• evaluation of material composition and degradation products;

• documentation of risk estimation and risk evaluation;

• relevance for MDR and global market access strategies;

• patient safety evidence.

For manufacturers, the key message is that biological evaluation should be planned early and documented clearly, especially where long-term toxicological endpoints may be relevant to the device’s materials, intended use and duration of contact.