Search Harmonised Standards in ASEAN: ASEAN BODY

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