SIST EN ISO 23118:2021
(Main)Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)
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.
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für Metabolomuntersuchungen in Urin, venösem Blutserum und -plasma (ISO 23118:2021)
Dieses Dokument legt die Anforderungen an die Handhabung, Dokumentation und Verarbeitung von für die Metabolomanalyse vorgesehenem Urin, venösem Blutplasma und serum während der präanalytischen Phase fest und gibt entsprechende Empfehlungen. Dieses Dokument gilt für Metabolomuntersuchungen und kann von biomedizinischen Laboren, Kunden dieser Labore, Entwicklern und Herstellern von In vitro-Diagnostika, Einrichtungen und kommerziellen Organisationen, die in der biomedizinischen Forschung tätig sind, Biobanken und Aufsichtsbehörden angewendet werden.
Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour l'analyse du métabolome dans l'urine et le sang veineux (sérum et plasma) (ISO 23118:2021)
Le présent document spécifie les exigences et donne des recommandations concernant la manipulation, la documentation et le traitement de l’urine et du sang veineux (plasma et sérum) destinés à l’analyse métabolomique lors du processus préanalytique. Le présent document est applicable aux analyses métabolomiques et peut être utilisé par les laboratoires biomédicaux, les clients de laboratoires, les développeurs et fabricants de diagnostics in vitro, les organismes et sociétés de recherche biomédicale, les biobanques et les autorités réglementaires.
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese metabolomike v urinu, serumu in plazmi venske krvi (ISO 23118:2021)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2021
Nadomešča:
SIST-TS CEN/TS 16945:2016
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese metabolomike v urinu, serumu in plazmi venske krvi (ISO 23118:2021)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für Metabolomuntersuchungen in Urin, venösem Blutserum und
-plasma (ISO 23118:2021)
Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour l'analyse du métabolome dans l'urine et le sang veineux (sérum et
plasma) (ISO 23118:2021)
Ta slovenski standard je istoveten z: EN ISO 23118:2021
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 23118
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2021
EUROPÄISCHE NORM
ICS 11.100.10 Supersedes CEN/TS 16945:2016
English Version
Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes in metabolomics in urine,
venous blood serum and plasma (ISO 23118:2021)
Analyses de diagnostic moléculaire in vitro - Molekularanalytische in-vitro-diagnostische Verfahren
Spécifications relatives aux processus préanalytiques - Spezifikationen für präanalytische Prozesse für
pour l'analyse du métabolome dans l'urine et le sang Metabolomuntersuchungen in Urin, venösem
veineux (sérum et plasma) (ISO 23118:2021) Blutserum und -plasma (ISO 23118:2021)
This European Standard was approved by CEN on 20 May 2021.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23118:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 23118:2021) has been prepared by Technical Committee ISO/TC 212 "Clinical
laboratory testing and in vitro diagnostic test systems" in collaboration with Technical Committee
CEN/TC 140 “In vitro diagnostic medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by December 2021, and conflicting national standards
shall be withdrawn at the latest by June 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN/TS 16945:2016.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 23118:2021 has been approved by CEN as EN ISO 23118:2021 without any modification.
INTERNATIONAL ISO
STANDARD 23118
First edition
2021-05
Molecular in vitro diagnostic
examinations — Specifications
for pre-examination processes in
metabolomics in urine, venous blood
serum and plasma
Analyses de diagnostic moléculaire in vitro — Spécifications relatives
aux processus préanalytiques pour l'analyse du métabolome dans
l'urine et le sang veineux (sérum et plasma)
Reference number
ISO 23118:2021(E)
©
ISO 2021
ISO 23118:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii © ISO 2021 – All rights reserved
ISO 23118:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General considerations . 3
5 Urine . 4
5.1 Outside the laboratory . 4
5.1.1 Urine collection . 4
5.1.2 Transport requirements . 5
5.2 Inside the laboratory . 5
5.2.1 Specimen reception . 5
5.2.2 Storage requirements . 6
5.2.3 Urine sample processing . 6
5.2.4 Long-term storage requirements for urine samples. 6
5.2.5 Urine thawing . 6
6 Blood . 7
6.1 Outside the laboratory . 7
6.1.1 Primary collection . 7
6.1.2 Transport of pre-processed specimens to laboratory . 8
6.2 Inside the laboratory . 8
6.2.1 Specimen reception . 8
6.2.2 Sample processing . 9
6.2.3 Transport of processed samples to a laboratory for metabolomics analysis
or transport to a biobank . 9
6.2.4 Long-term storage requirements . 9
6.2.5 Serum and plasma thawing and use .10
Annex A (informative) Instability of the metabolome.11
Bibliography .17
ISO 23118:2021(E)
Foreword
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This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in
vitro diagnostic test systems, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 140, In vitro diagnostic medical devices, in accordance with the Agreement
on technical cooperation between ISO and CEN (Vienna Agreement).
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iv © ISO 2021 – All rights reserved
ISO 23118:2021(E)
Introduction
Metabolomics is the "-omic" science that deals with the charact
...
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