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ISO 10993-3:2026

Biological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity

Aug 6, 2026

General information

60.60     Aug 6, 2026

ISO

ISO/TC 194

International Standard

11.100.20  

English   French  

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Scope

This document specifies strategies for risk estimation and evaluation of biological harms with respect to:

genotoxicity;
carcinogenicity;
reproductive toxicity; and
developmental toxicity.

This document is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity has been established.
This document is not applicable to active pharmaceutical ingredients of device-drug combination products or biological components of device-biologic combination products which are covered by regulations.
NOTE            Guidance on selecting relevant biological effects for medical devices is covered in ISO 10993-1.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 10993-3:2014

WITHDRAWN
ISO/TR 10993-33:2015

NOW

PUBLISHED
ISO 10993-3:2026
60.60 Standard published
Aug 6, 2026

National adoptions

dnaSRPS EN ISO 10993-3:2024  
ISS

Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity (ISO/FDIS 10993-3:2026)

50.60   Close of voting. Proof returned by secretariat

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