60.60 Standard published Aug 6, 2026
ISO
ISO/TC 194 Biological and clinical evaluation of medical devices
International Standard
11.100.20 Biological evaluation of medical devices
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.
PUBLISHED
ISO 10993-3:2026
60.60
Standard published
Aug 6, 2026