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BS EN ISO 23118:2021

BS EN ISO 23118:2021

$142.49

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma

Published By Publication Date Number of Pages
BSI 2021 28
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This document specifies requirements and gives recommendations for the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis in the pre-examination processes. This document is applicable to metabolomics examinations and can be used by biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
11 4 General considerations
12 5 Urine
5.1 Outside the laboratory
5.1.1 Urine collection
13 5.1.2 Transport requirements
5.2 Inside the laboratory
5.2.1 Specimen reception
14 5.2.2 Storage requirements
5.2.3 Urine sample processing
5.2.4 Long-term storage requirements for urine samples
5.2.5 Urine thawing
15 6 Blood
6.1 Outside the laboratory
6.1.1 Primary collection
16 6.1.2 Transport of pre-processed specimens to laboratory
6.2 Inside the laboratory
6.2.1 Specimen reception
17 6.2.2 Sample processing
6.2.3 Transport of processed samples to a laboratory for metabolomics analysis or transport to a biobank
6.2.4 Long-term storage requirements
18 6.2.5 Serum and plasma thawing and use
19 Annex A (informative) Instability of the metabolome
25 Bibliography

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BS EN ISO 23118:2021
$142.49