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

Autor: Vanstapel, F.J.L.A., Orth, M., Streichert, T., Capoluongo, E.D., Oosterhuis, W.P., Cubukcu, H.C., Bernabeu-Andreu, F.A., Thelen, M., Jacobs, L.H.J., Linko, S., Bhattoa, H.P., Bossuyt, P.M.M., Brguljan, P.M., Boursier, G., Cobbaert, C.M., Neumaier, M.

Publikováno v: Clinical Chemistry and Laboratory Medicine, 61, 4, pp. 608-626
Clinical Chemistry and Laboratory Medicine, 61, 608-626
Clinical Chemistry and Laboratory Medicine, 61(4). WALTER DE GRUYTER GMBH

Contains fulltext : 290896.pdf (Publisher’s version ) (Closed access) The EU In-Vitro Diagnostic Device Regulation (IVDR) aims for transparent risk-and purpose-based validation of diagnostic devices, traceability of results to uniquely identified d

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=dedup_wf_001::93d8bcb2ad3a7a33f7eea85a887c25f4
https://hdl.handle.net/1887/3590515

Validation and verification of examination procedures in medical laboratories: Opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validation

Autor: Roelofsen-De Beer, R. Wielders, J. Boursier, G. Vodnik, T. Vanstapel, F. Huisman, W. Vukasović, I. Vaubourdolle, M. Sönmez, Ç. Linko, S. Brugnoni, D. Kroupis, C. Lohmander, M. Šprongl, L. Bernabeu-Andreu, F. Meško Brguljan, P. Thelen, M.

This paper reflects the opinion of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO). It aims to provide guidance for drawing up local/national documents about va

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https://pergamos.lib.uoa.gr/uoa/dl/object/uoadl:3078268

Boron detection from blood samples by ICP-AES and ICP-MS during boron neutron capture therapy.

Autor: Linko, S.^1,2 (AUTHOR) solveig.linko@hus.fi, Revitzer, H.³ (AUTHOR), Zilliacus, R.⁴ (AUTHOR), Kortesniemi, M.^2,5 (AUTHOR), Kouri, M.^2,6 (AUTHOR), Savolainen, S.^2,5,7 (AUTHOR)

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Assessment of the state-of-the-art trueness and precision of serum total-calcium and glucose measurements in Finnish laboratories - the QSL-Finland study.

Autor: Linko, S, Himberg, J J, Thienpont, L, Stöckl, D, De Leenheer, A

Publikováno v: Scandinavian Journal of Clinical & Laboratory Investigation. 7/22/98, Vol. 58 Issue 3, p229-240. 12p.