Latest European device standards published:
This article was originally published in Clinica
The latest series of European standards for medical devices and diagnostics have been published in the Official Journal of the European Communities (C 288/41). Manufacturers conform to these standards to imply that they meet the relevant essential requirements of the European Union medical device directives on in vitro diagnostics (IVDs), medical devices (MDs) and active implantable medical devices (AIMDs). The new standards or parts of standards cover: culture media for microbiology (IVD); tests for in vitro cytotoxicity (MD and AIMD); validation and routine control of sterilisation by irradiation (MD); and 15 parts to the standards on electricomedical equipment ranging from gamma beam therapy equipment to endoscopic equipment and infant radiant monitors (AIMD).