ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro-Diagnostics Regulation: joint opinion of task force on European regulatory affairs and working group accreditation and ISO/CEN standards of the European Federation of Clinical Chemistry and Laboratory Medicine: review - Vanstapel, Florent; Orth, Matthias; Streichert, Thomas; Capoluongo, Ettore D.; Oosterhuis, Wytze P.; Çubukçu, Hikmet Can; Bernabeu-Andreu, Francisco A.; Thelen, Marc; Jacobs, Leo H. J.; Linko, Solveig; Bhattoa, Harjit Pal; Bossuyt, Patrick M. M.; et al. (Clinical chemistry and laboratory medicine, 2023)
Online veröffentlicht: 31. Januar 2023