Towards global in vitro diagnostic standards, Part II.
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.
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Powers Consulting Services, Pittsford, New York, USA. powers@frontiernet.net
D019411:Clinical Laboratory Techniques / Q000592:standards*; D019937:Diagnostic Techniques and Procedures / Q000592:standards*; D017408:Guidelines as Topic; D066298:In Vitro Techniques; D007391:International Cooperation; D009937:Organizational Objectives