DIN Standards Committee Optics and Precision Mechanics
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Abstract
ISO 10993-3:2014 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices: genotoxicity; carcinogenicity; reproductive and developmental toxicity. ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.
Begin
2023-11-01
WI
00206101
Planned document number
prEN ISO 10993-3 rev
Responsible national committee
NA 027-07-12 AA - Biological evaluation of medical devices
Responsible european committee
CEN/TC 206 - Biological and clinical evaluation of medical devices
