PD CEN/TS 16945:2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma
Hardcopy , PDF
06-07-2021
English
05-31-2016
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European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General Considerations
5 Urine
6 Blood
Annex A (informative) - Long-term stability of
urine and serum [1]H NMR metabolic profiles
Bibliography
Defines the preanalytical phase and recommends the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis.
| Committee |
CH/212
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
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.
| Standards | Relationship |
| CEN/TS 16945:2016 | Identical |
| ISO/TS 80004-6:2013 | Nanotechnologies Vocabulary Part 6: Nano-object characterization |
| ISO 15189:2012 | Medical laboratories — Requirements for quality and competence |
| ISO 15190:2003 | Medical laboratories Requirements for safety |
| ISO Guide 30:2015 | Reference materials — Selected terms and definitions |
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