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Towards global in vitro diagnostic standards, Part II
1Powers Consulting Services, Pittsford, New York, USA. powers@frontiernet.net
Abstract:
The first global harmonized standards for in vitro diagnostic (IVD) products are nearing completion. Six of these standards are mandated for the IVD Directive. Part II of this two-part article continues with a report on the current status of these standards and reflects on the lessons learned so far from international standardization activity.

