Title Of Document
Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Abstract
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.
Category of Standards
Category 1
Document number assigned by ASEAN
ISO 10993-3:2014
ICS
HS
HS Range
MRA/Harmonised Regulations related to the Standard
ASEAN Body responsible for Standard
ASEAN Medical Device Committee (AMDC)
Member States
BN
ID
KH
LA
MM
MY
PH
SG
TH
VN
Date of harmonisation in ASEAN
16/10/2025
Date of Latest Review
Links :
Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity