Towards global in vitro diagnostic standards, Part I.

The first global harmonized standards for in vitro diagnostic products (IVD) are nearing completion. The ISO Technical Committee overseeing this work will meet in June 2000 to prepare for the final vote. Six of these standards are mandated for the IVD Directive. This two-part report on the current status of these standards provides an insight into the international standardization process and suggests ways that industry can make it work more effectively.