PD CEN/TS 16945:2016
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for metabolomics in urine@ venous blood serum and plasma
- Standard No.
- PD CEN/TS 16945:2016
- Release Date
- 2016
- Published By
- European Committee for Standardization (CEN)
- Latest
- PD CEN/TS 16945:2016
- Replace
- FprCEN/TS 16945-2015
- Scope
- This Technical Specification covers the preanalytical phase and recommends the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis. This Technical Specification is applicable to metabolomics examinations and is of importance to biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities. The adoption of the described procedures for the preanalytical phase make it possible to compare and evaluate the results obtained from metabolic profiling analysis.
PD CEN/TS 16945:2016 Referenced Document
- EN ISO 15189:2012 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)*， 2024-04-20 Update
- ISO 15190:2003 Medical laboratories - Requirements for safety
- ISO Guide 30:1992 Terms and definitions used in connection with reference materials
- ISO/TS 80004-6:2013 Nanotechnologies.Vocabulary.Part 6: Nano-object characterization
PD CEN/TS 16945:2016 history
- 2016 PD CEN/TS 16945:2016 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for metabolomics in urine@ venous blood serum and plasma
