BS EN ISO 23118:2021 – TC:2022 Edition
$186.33
Tracked Changes. 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 | 2022 | 64 |
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 |
|---|---|
| 38 | National foreword |
| 40 | European foreword |
| 42 | Foreword |
| 43 | Introduction |
| 45 | 1 Scope 2 Normative references 3 Terms and definitions |
| 47 | 4 General considerations |
| 48 | 5 Urine 5.1 Outside the laboratory 5.1.1 Urine collection |
| 49 | 5.1.2 Transport requirements 5.2 Inside the laboratory 5.2.1 Specimen reception |
| 50 | 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 |
| 51 | 6 Blood 6.1 Outside the laboratory 6.1.1 Primary collection |
| 52 | 6.1.2 Transport of pre-processed specimens to laboratory 6.2 Inside the laboratory 6.2.1 Specimen reception |
| 53 | 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 |
| 54 | 6.2.5 Serum and plasma thawing and use |
| 55 | Annex A (informative) Instability of the metabolome |
| 61 | Bibliography |
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