Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA

This document specifies requirements and gives recommendations on the handling, storage, processing and documentation of body fluids specimens intended for human cfDNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health institutions including facilities collecting and handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Dedicated measures that need to be taken for cytohistological analysis of body fluid derived nucleated cells are not described in this technical specification. Neither are measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described.
Different dedicated measures need to be taken for preserving ccfDNA from other body fluids such as blood, lymph and others. These are not described in this document. ccfDNA from blood is covered in EN ISO 20186 3.
NOTE   International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für Urin und andere Körperflüssigkeiten - Isolierte zellfreie DNA

Dieses Dokument legt Anforderungen fest an und gibt Empfehlungen für die Handhabung, Lagerung, Verarbeitung und Dokumentation von für die Untersuchung von humaner cfDNA vorgesehenen Körperflüssigkeitenproben während der präanalytischen Phase vor der Durchführung einer molekularen Analyse.
Dieses Dokument ist anwendbar auf molekulare in vitro-diagnostische Untersuchungen, die in medizinischen Laboratorien durchgeführt werden. Es ist darüber hinaus für die Verwendung durch Gesundheitseinrichtungen, einschließlich Einrichtungen, die Primärproben entnehmen und handhaben, Laborkunden, Entwickler und Hersteller von In vitro-Diagnostika, Biobanken, in der biomedizinischen Forschung tätige Einrichtungen und kommerzielle Organisationen sowie Aufsichtsbehörden, vorgesehen.
Spezielle Maßnahmen, die bei der zytohistologischen Analyse von aus Körperflüssigkeiten entnommenen kernhaltigen Zellen erforderlich sind, werden in dieser Technischen Spezifikation nicht beschrieben. Des Weiteren werden auch keine Maßnahmen zur Konservierung und Handhabung von Pathogen- und sonstiger bakterieller oder Mikrobiom-DNA in Körperflüssigkeiten beschrieben.
Für die Konservierung von ccfDNA aus anderen Körperflüssigkeiten wie Blut, Lymphe u. a. müssen abweichende spezielle Maßnahmen getroffen werden. Diese werden nicht in diesem Dokument beschrieben. ccfDNA aus Blut ist Gegenstand von EN ISO 20186-3.
ANMERKUNG   Für bestimmte Aspekte, die in diesem Dokument behandelt werden, können auch internationale, nationale oder regionale Bestimmungen oder Anforderungen gelten.

Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese pregleda urina in drugih telesnih tekočin - Izolirana brezcelična DNK

Ta dokument določa zahteve ter podaja priporočila glede obravnave, shranjevanja, obdelave in dokumentiranja vzorcev telesnih tekočin, namenjenih za preiskave cirkulirajoče brezcelične DNK (cfDNA) med predpreiskovalno fazo, preden se izvede molekularna preiskava.
Ta dokument se uporablja za molekularne diagnostične preiskave in vitro, ki jih izvajajo v medicinskih laboratorijih. Uporabljale naj bi ga tudi zdravstvene ustanove, vključno z ustanovami, ki zbirajo in obravnavajo vzorce, laboratorijske stranke, razvijalci in proizvajalci diagnostike in vitro, biobanke, institucije in komercialne organizacije, ki izvajajo biomedicinske raziskave, ter regulativni organi.
V tej tehnični specifikaciji niso opisani namenski ukrepi za citohistološko analizo celic z jedri, pridobljenih iz telesnih tekočin. Prav tako niso opisani ukrepi za ohranjanje in ravnanje s patogeni ter drugo bakterijsko ali mikrobiomsko DNK v telesnih tekočinah.
Za ohranjanje cirkulirajoče brezcelične DNK iz drugih telesnih tekočin, kot so kri, limfa in ostale tekočine, je treba uporabiti drugačne namenske ukrepe. Slednji niso opisani v tem dokumentu. Cirkulirajoča brezcelična DNK iz krvi je obravnavana v standardu EN ISO 20186 3.
OPOMBA:   Za določene teme, ki so zajete v tem dokumentu, lahko veljajo tudi mednarodni, nacionalni ali regionalni predpisi ali zahteve.

General Information

Status
Published
Public Enquiry End Date
30-Mar-2022
Publication Date
21-Aug-2022
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
04-Aug-2022
Due Date
09-Oct-2022
Completion Date
22-Aug-2022

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN/TS 17811:2022
01-september-2022
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese pregleda urina in drugih telesnih tekočin - Izolirana brezcelična DNK
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for urine and other body fluids - Isolated cell free DNA
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für Urin und andere Körperflüssigkeiten - Isolierte zellfreie DNA
Ta slovenski standard je istoveten z: CEN/TS 17811:2022
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
SIST-TS CEN/TS 17811:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST-TS CEN/TS 17811:2022

---------------------- Page: 2 ----------------------
SIST-TS CEN/TS 17811:2022


CEN/TS 17811
TECHNICAL SPECIFICATION

SPÉCIFICATION TECHNIQUE

June 2022
TECHNISCHE SPEZIFIKATION
ICS 11.100.10
English Version

Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for urine and other body
fluids - Isolated cell free DNA
 Molekularanalytische in-vitro-diagnostische Verfahren
- Spezifikationen für präanalytische Prozesse für Urin
und andere Körperflüssigkeiten - Isolierte zellfreie
DNA
This Technical Specification (CEN/TS) was approved by CEN on 17 May 2022 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, 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 17811:2022 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST-TS CEN/TS 17811:2022
CEN/TS 17811:2022 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General requirements . 10
5 Outside the laboratory . 11
5.1 Specimen collection . 11
5.1.1 Information about the patient or specimen donor . 11
5.1.2 Selection of the body fluid collection device by the laboratory . 12
5.1.3 Body fluid specimen collection from the patient/donor and stabilization procedures. 12
5.1.4 Information about the specimen storage requirements at the body fluid collection
facility/site . 14
5.2 Transport re
...

SLOVENSKI STANDARD
kSIST-TS FprCEN/TS 17811:2022
01-marec-2022
Molekularne diagnostične preiskave in vitro - Specifikacije za postopke pred
pregledom urina in drugih telesnih tekočin - Izolirana prosta celična DNK
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for urine and other body fluids - Isolated cell free DNA
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für Urin und andere Körperflüssigkeiten - Isolierte zellfreie DNA
Ta slovenski standard je istoveten z: FprCEN/TS 17811
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
kSIST-TS FprCEN/TS 17811:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
kSIST-TS FprCEN/TS 17811:2022

---------------------- Page: 2 ----------------------
kSIST-TS FprCEN/TS 17811:2022


FINAL DRAFT
TECHNICAL SPECIFICATION
FprCEN/TS 17811
SPÉCIFICATION TECHNIQUE

TECHNISCHE SPEZIFIKATION

January 2022
ICS 11.100.10
English Version

Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for urine and other body
fluids - Isolated cell free DNA
 Molekularanalytische in-vitro-diagnostische Verfahren
- Spezifikationen für präanalytische Prozesse für Urin
und andere Körperflüssigkeiten - Isolierte zellfreie
DNA


This draft Technical Specification is submitted to CEN members for Vote. It has been drawn up by the Technical Committee
CEN/TC 140.

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.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a Technical Specification. It is distributed for review and comments. It is subject to change
without notice and shall not be referred to as a Technical Specification.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TS 17811:2022 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
kSIST-TS FprCEN/TS 17811:2022
FprCEN/TS 17811:2022 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General requirements . 10
5 Outside the laboratory . 11
5.1 Specimen collection . 11
5.1.1 Information about the patient or specimen donor . 11
5.1.2 Selection of the body fluid collection device by the laboratory . 12
5.1.3 Body fluid specimen collection from the patient/donor and stabilization procedures. 12
5.1.4 Information about the specimen storage requirements at the body fluid collection
facility/site . 14
5.2 Transport requirements. 15
5.2.1 General .
...

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