Successful course on CEN and ISO Standards for Pre-analytical Processes
CEN and ISO Standards for Pre-analytical Processes in Industrial Development and Medical Diagnostics
The course organized by the Institute of Pathology, SPIDIA4P, QIAGEN and BBMRI.at was held in Graz, Austria, and raised awareness about the existence and relevance of the CEN Technical Specifications and ISO Standards and of standardizing pre-analytical processes in R&D and medical diagnostics.
International participants learned about which CEN Technical Specifications (CEN/TS) “In-Vitro Diagnostic examinations ‑ Specifications for Pre-examination Processes” have already been published and which pre-analytical CEN/TS and ISO Standards are under development.
The main focus of the course on May 16, 2018 was on demonstrating their relevance for medical diagnostics and research and development (R&D), particularly in the context of the new In-Vitro Diagnostic Regulation. The development process of standards was introduced and an overview on the structure and scope were given.
The major pre-analytical factors and their influence on analysis results in pathology and human genetic laboratories were addressed and examples of how to implement the standards were given. Participants also had the opportunity to test the BBMRI-ERIC online Self Assessment Tool.
All participants rated the course ‘excellent’.
