Title Of Document
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
Abstract
ISO 10993-5:2009 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.
Category of Standards
Category 1
Document number assigned by ASEAN
ISO 10993-5:2009
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
16/03/2022
Date of Latest Review
Links :
Biological evaluation of medical devices ? Part 5: Tests for in vitro cytotoxicity