Search Harmonised Standards in ASEAN: ICS

Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices / ISO 10993-13:2010

ISO 10993?13:2010 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices…  [More Details+]

Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics / ISO 10993-14:2001

This part of ISO 10993 specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. It also…  [More Details+]

Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity / 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…  [More Details+]

ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity / ISO 10993-5:2009

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…  [More Details+]

Medical laboratories -- Requirements for safety / ISO 15190:2003

ISO 15190:2003 specifies requirements for safe practices in the medical laboratory.  [More Details+]