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CEN/TS 16945:2016

(Main)

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

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

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.

Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für Metabolomuntersuchungen in Urin, venösem Blutserum und -plasma

Diese Technische Spezifikation umfasst die präanalytische Phase und gibt Empfehlungen zur Handhabung, Dokumentation und Verarbeitung von für die Metabolomanalyse vorgesehenem Urin, venösem Blutplasma und  serum. Diese Technische Spezifikation gilt für Metabolomuntersuchungen und ist für biomedizinische Labore, Kunden dieser Labore, Entwickler und Hersteller von In-vitro-Diagnostika, Einrichtungen und kommerzielle Organisationen, die in der biomedizinischen Forschung tätig sind, Biobanken und Aufsichts-behörden von Bedeutung.
Die Übernahme der beschriebenen Verfahren für die präanalytische Phase ermöglicht den Vergleich und die Bewertung der aus der Analyse durch Erstellung eines metabolischen Profils erhaltenen Ergebnisse.

Tests 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)

Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese metabolomike v urinu, serumu in plazmi venske krvi

Ta tehnična specifikacija zajema predanalizno fazo in vsebuje priporočila za obravnavo, dokumentiranje ter obdelavo urina, seruma in plazma venske krvi, ki so namenjeni za metabolomično analizo. Ta tehnična specifikacija se uporablja za metabolomične preiskave in je ključnega pomena za biomedicinske laboratorije, laboratorijske stranke, razvijalce in proizvajalce diagnostike »in vitro«, institucije in podjetja, ki izvajajo biomedicinske raziskave, biobanke ter regulativne organe.
Sprejetje opisanih postopkov za predanalizno fazo mogoča primerjavo in ocenjevanje rezultatov analize metaboličnega profiliranja.

General Information

Status
Withdrawn
Publication Date
17-May-2016
Withdrawal Date
01-Jun-2021
ICS
11.100.10 - In vitro diagnostic test systems
Technical Committee
CEN/TC 140 - In vitro diagnostic systems
Drafting Committee
CEN/TC 140/WG 3 - Quality management in the medical laboratory
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
02-Jun-2021
Ref Project
SIST-TS CEN/TS 16945:2016 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma

Relations

Replaced By
EN 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)
Effective Date
09-Jun-2021

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN/TS 16945:2016
01-julij-2016
0ROHNXODUQHGLDJQRVWLþQHSUHLVNDYHLQYLWUR6SHFLILNDFLMH]DSUHGSUHLVNRYDOQH
SURFHVHPHWDERORPLNHYXULQXVHUXPXLQSOD]PLYHQVNHNUYL
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for metabolomics in urine, venous blood serum and plasma
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für Metabolomuntersuchungen in Urin, venösem Blutserum und
-plasma
Ta slovenski standard je istoveten z: CEN/TS 16945:2016
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST-TS CEN/TS 16945:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN/TS 16945:2016

---------------------- Page: 2 ----------------------

SIST-TS CEN/TS 16945:2016


CEN/TS 16945
TECHNICAL SPECIFICATION

SPÉCIFICATION TECHNIQUE

May 2016
TECHNISCHE SPEZIFIKATION
ICS 11.100.10
English Version

Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for metabolomics in urine,
venous blood serum and plasma
Tests de diagnostic moléculaire in vitro - Spécifications Molekularanalytische in-vitro-diagnostische Verfahren
relatives aux processus préanalytiques pour l'analyse - Spezifikationen für präanalytische Prozesse für
du métabolome dans l'urine et le sang veineux (sérum Metabolomuntersuchungen in Urin, venöses Blutserum
et plasma) und -plasma
This Technical Specification (CEN/TS) was approved by CEN on 22 March 2016 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 16945:2016 E
worldwide for CEN national Members.

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SIST-TS CEN/TS 16945:2016
CEN/TS 16945:2016 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General Considerations. 7
5 Urine . 8
5.1 Outside the laboratory . 8
5.1.1 Urine collection manual . 8
5.1.2 Transport requirements. 9
5.2 Inside the laboratory .
...

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