Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Dagher, G; Becker, KF; Bonin, S; Foy, C; Gelmini, S; Kubista, M; Kungl, P; Oelmueller, U; Parkes, H; Pinzani, P; Riegman, P; Schröder, U; Stumptner, C; Turano, P; Sjöback, R; Wutte, A; Zatloukal, K.
Pre-analytical processes in medical diagnostics: New regulatory requirements and standards.
N Biotechnol. 2019; 52:121-125
Doi: 10.1016/j.nbt.2019.05.002
Web of Science
PubMed
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FullText_MUG
- Führende Autor*innen der Med Uni Graz
- Dagher Georges
- Zatloukal Kurt
- Co-Autor*innen der Med Uni Graz
- Kungl Penelope
- Stumptner Cornelia
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- Abstract:
- In May 2017, the European In Vitro Diagnostic Regulation (IVDR) entered into force and will apply to in vitro diagnostics from May 26th, 2022. This will have a major impact on the in vitro diagnostics (IVD) industry as all devices falling under the scope of the IVDR will require new or re-certification. It will also affect health institutions developing and using in-house devices. The IVDR also has implications with respect to product performance validation and verification including the pre-analytics of biological samples used by IVD developers and diagnostic service providers. In parallel to the IVDR, a series of standards on pre-analytical sample processing has been published by the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN). These standards describe pre-analytical requirements for various types of analyses in various types of biospecimens. They are of relevance for IVD product developers in the context of (re)certification under the IVDR and to some extent also to devices manufactured and used only within health institutions. This review highlights the background and the rational for the pre-analytical standards. It describes the procedure that leads to these standards, the major implications of the standards and the requirements on pre-analytical workflows. In addition, it discusses the relationship between the standards and the IVDR. Copyright © 2019. Published by Elsevier B.V.
- Find related publications in this database (using NLM MeSH Indexing)
- Diagnostic Techniques and Procedures - standards
- Equipment and Supplies - standards
- Humans -
- Pre-Analytical Phase - standards
- Reference Standards -
- Social Control, Formal -
- Find related publications in this database (Keywords)
- In vitro diagnostic regulation
- Molecular diagnostics
- In vitro diagnostic medical device
- Pre-analytics
- ISO standard
- CEN technical specification