Standardization in biobanking - Between cooperation and competition

Abstract

This article presents the current situation of German biobanks and shows future fields of action in the European and international context on the basis of upcoming legal and normative challenges. It gives an overview of the development of the international biobank standard ISO 20387 and the commitment of German biobank experts in the ISO committee TC276. Less attention than the biobank standard per se has so far been paid to the basic mechanisms by which standards are developed and the potential of their application and accreditation. In this sense, this article deals with the motivation for active participation in standardization projects. We discuss the status of ISO 20387 as a conformity assessment standard and the consequence of accreditation as a performance monitor.