BBMRI.at Delegates at ISO/TC 212 Work Group 4 Meeting
BBMRI.at representatives from Med Uni Graz regularly participate in ISO/TC 212 Work Group 4 – Microbiology and molecular diagnostics – meetings. The last one took place from 11-14 June 2024 at DIN in Berlin. The major goal was to refine and to develop new ISO standards for microbiology and molecular diagnostics.
Supporting to develop and establish ISO and CEN quality standards relevant for biobanks and biomedical laboratories is an important part of the work of BBMRI.at and its partners. BBMRI.at Executive Manager Cornelia Stumptner and former BBMRI.at Director Kurt Zatloukal from the Medical University of Graz took part in an ISO/TC 212 WG4 meeting from 11-14 June 2024 at the German Institute for Standardization (Deutsches Institut für Normierung, DIN) in Berlin, Germany.
Both BBMRI.at representatives are part of this ISO working group that has already developed a series of 22 standards on “Molecular in vitro diagnostic examinations” that were developed as part of the EU project SPIDIA4P (Standardisation of generic Pre-analytical procedures for Invitro DIAgnostics for Personalized Medicine) where BBMRI.at partner Med Uni Graz was also involved as a project partner. Five of these standards which are currently European CEN standards are now developed into international ISO standards.
In addition to these pre-examination (pre-analytical) sample quality standards, also other ISO standards highly relevant for the medical molecular diagnostic field are being newly developed.
The respective standards are:
From the standard series ‘Molecular in vitro diagnostic examinations – ‘
- Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood
- ISO/DTS 7552-1 Part 1: Isolated RNA
- ISO/DTS 7552-2 Part 2: Isolated DNA
- ISO/DTS 7552-3 Part 3: Preparations for analytical CTC staining
- ISO/PWI TS 18701 Specifications for pre-examination processes for human specimens — Isolated microbiome DNA
- ISO/PWI TS 18702 Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood — DNA, RNA and proteins
- ISO/PWI 18703 Specifications for pre-examination processes for venous whole blood — Isolated circulating cell free RNA from plasma
- ISO/CD 18704 Specifications for pre-examination processes for urine and other body fluids — Isolated cell free DNA
Other quality standards, such as:
- ISO/AWI TS 8219 Sequencing and clinical application to infectious diseases
- ISO/DIS 21474-3 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acidsPart 3: Interpretation and reports
- ISO/AWI 24051-2 Medical laboratories – Part 2: Digital pathology and artificial intelligence (AI)-based image analysis
