Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)

This document provides recommendations and requirements on the handling, storage, processing and documentation of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) examination during the pre-examination phase before an analytical test is performed. This document covers specimens collected in venous whole blood collection tubes.
This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for stabilizing blood genomic DNA, which are not described in this document. Blood genomic DNA is covered in ISO 20186-2.
Different dedicated measures are taken for preserving DNA in circulating exosomes, which are not described in this document.
NOTE    ccfDNA obtained from blood by the procedures cited in this document can contain DNA originally present in exosomes[8][9].
DNA in pathogens present in blood is not covered by this document.

Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für venöse Vollblutproben - Teil 3: Aus Plasma isolierte zirkulierende zellfreie DNA (ISO 20186-3:2019)

Dieses Dokument enthält Empfehlungen und Anforderungen für die Handhabung, Lagerung, Verarbeitung und Dokumentation von venösen Vollblutproben, die für die Untersuchung zirkulierender zellfreier DNA (ccfDNA) vorgesehen sind, während der präanalytischen Phase vor Beginn einer analytischen Prüfung. Dieses Dokument behandelt Untersuchungsmaterial, das in Blutentnahmeröhrchen für venöses Vollblut entnommen wurde.
Dieses Dokument gilt für alle molekularen in vitro diagnostischen Untersuchungen, die in medizinischen Laboren durchgeführt werden. Es ist außerdem auch für die Verwendung durch Labor Kunden, Entwickler und Hersteller von In vitro Diagnostika, Biobanken, Einrichtungen und kommerzielle Organisationen, die in der biomedizinischen Forschung tätig sind, sowie durch Aufsichtsbehörden vorgesehen.
Zur Stabilisierung genomischer DNA aus Blut werden andere spezielle Maßnahmen getroffen, die nicht in diesem Dokument beschrieben sind. Genomische DNA aus Blut wird in ISO 20186 2 behandelt.
Zur Erhaltung der DNA in zirkulierenden Exosomen werden andere zweckbestimmte Maßnahmen ergriffen, die in diesem Dokument nicht beschrieben werden.
ANMERKUNG   ccfDNA, die mit den in diesem Dokument vorgeschlagenen Verfahren aus Blut gewonnen wurde, kann DNA enthalten, die ursprünglich in Exosomen vorlag [8], [9].
Nicht durch dieses Dokument abgedeckt ist DNA, die in Krankheitserregern im Blut vorhanden ist.

Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour le sang total veineux - Partie 3: ADN libre circulant extrait du plasma (ISO 20186-3:2019)

Le présent document fournit des recommandations et des exigences sur la manipulation, le stockage, le traitement et la documentation des prélèvements de sang total veineux destinés à l'analyse de l'ADN libre circulant (ADNlc) durant la phase préanalytique précédant la réalisation d'un essai analytique. Le présent document concerne les échantillons primaires prélevés dans des tubes de prélèvement de sang total veineux.
Le présent document s'applique aux analyses de diagnostic moléculaire in vitro réalisées par des laboratoires de biologie médicale. Il est également destiné à être utilisé par des clients de laboratoires, des développeurs et fabricants de l'industrie du diagnostic in vitro, ainsi que par des biobanques, des institutions et des organismes commerciaux spécialisés en recherche biomédicale, de même que des autorités de réglementation.
Des mesures spécifiques différentes, non décrites dans le présent document, sont prises pour stabiliser l'ADN génomique sanguin. L'ADN génomique sanguin est couvert par l'ISO 20186-2.
Des mesures spécifiques différentes, non décrites dans le présent document, sont prises pour préserver l'ADN des exosomes circulants.
NOTE       L'ADNlc extrait du sang à l'aide des protocoles cités dans le présent document est susceptible de contenir de l'ADN présent à l'origine dans les exosomes[8][9].
L'ADN des pathogènes présents dans le sang n'est pas couvert par le présent document.

Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese za vensko polno kri - 3. del: Iz plazme izolirana cirkulirajoča brezcelična DNK (ISO 20186-3:2019)

Ta mednarodni standard vsebuje priporočila za obravnavo, dokumentiranje, shranjevanje in obdelavo vzorcev venske polne krvi, namenjenih za analizo cirkulirajoče brezcelične DNK (ccfDNA) med predpreiskovalno fazo, preden se izvede molekularni preskus. Ta mednarodni standard zajema vzorce, ki so zbrani s cevkami za zbiranje venske polne krvi. Ta mednarodni standard se uporablja za molekularne diagnostične preiskave in vitro, vključno z laboratorijsko razvitimi preskusi, ki jih izvajajo v medicinskih laboratorijih. Uporabljali naj bi ga tudi uporabniki laboratorijev, razvijalci in proizvajalci diagnostike in vitro, navezuje pa se tudi na institucije in komercialne organizacije, ki izvajajo biomedicinske raziskave, biobanke ter regulativne organe. Profili cirkulirajoče brezcelične DNK se lahko znatno spremenijo po odvzemu krvi od darovalca (npr. sprostitev genomske DNK iz belih krvnih celic, razpad ali sprememba količine cirkulirajoče brezcelične DNK). Zato je treba sprejeti posebne ukrepe za pridobivanje vzorcev krvi dobre kakovosti za analizo in shrambo cirkulirajoče brezcelične DNK. Za ohranjanje krvne genomske DNK je treba uporabiti drugačne namenske ukrepe, ki niso opisani v tem mednarodnem standardu. Krvna genomska DNK je opisana v standardu ISO 20185-2, Molekularne diagnostične preiskave in vitro – specifikacije za predpreiskovalne procese za vensko polno kri - 2. del: Iz genoma izolirana DNK OPOMBA: cirkulirajoča brezcelična DNK iz krvi, pridobljena s postopki, ki jih predlaga ta dokument, lahko vsebuje DNK iz eksosomov. Patogena DNK v krvi ni zajeta v tem mednarodnem standardu. Za ohranjanje DNK v cirkulirajočih eksosomih je treba uporabiti drugačne namenske ukrepe, ki niso opisani v tem mednarodnem standardu. OPOMBA: Za določene teme, ki so zajete v tem mednarodnem standardu, lahko veljajo tudi mednarodni, nacionalni ali regionalni predpisi ali zahteve.

General Information

Status
Published
Publication Date
22-Oct-2019
Withdrawal Date
30-Oct-2022
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
23-Oct-2019
Due Date
11-Aug-2018
Completion Date
23-Oct-2019

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 20186-3:2020
01-januar-2020
Nadomešča:
SIST-TS CEN/TS 16835-3:2015
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese za vensko polno kri - 3. del: Iz plazme izolirana cirkulirajoča brezcelična
DNK (ISO 20186-3:2019)
Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes
for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO
20186-3:2019)
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für venöse Vollblutproben - Teil 3: Aus Plasma isolierte
zirkulierende zellfreie DNS (ISO 20186-3:2019)
Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus pré-
analytiques pour le sang - ARN cellulaire - Partie 3: ADN libre circulant extrait du plasma
(ISO 20186-3:2019)
Ta slovenski standard je istoveten z: EN ISO 20186-3:2019
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
SIST EN ISO 20186-3:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 20186-3:2020

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SIST EN ISO 20186-3:2020


EN ISO 20186-3
EUROPEAN STANDARD

NORME EUROPÉENNE

October 2019
EUROPÄISCHE NORM
ICS 11.100.10
English Version

Molecular in-vitro diagnostic examinations - Specifications
for pre-examination processes for venous whole blood -
Part 3: Isolated circulating cell free DNA from plasma (ISO
20186-3:2019)
Analyses de diagnostic moléculaire in vitro - Molekularanalytische in-vitro-diagnostische Verfahren
Spécifications relatives aux processus préanalytiques - Spezifikationen für präanalytische Prozesse für
pour le sang total veineux - Partie 3: ADN libre venöse Vollblutproben - Teil 3: Aus Plasma isolierte
circulant extrait du plasma (ISO 20186-3:2019) zirkulierende zellfreie DNA (ISO 20186-3:2019)
This European Standard was approved by CEN on 14 September 2019.

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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20186-3:2019 E
worldwide for CEN national Members.

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SIST EN ISO 20186-3:2020
EN ISO 20186-3:2019 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------
SIST EN ISO 20186-3:2020
EN ISO 20186-3:2019 (E)
European foreword
This document (EN ISO 20186-3:2019) 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 April 2020, and conflicting national standards shall be
withdrawn at the latest by October 2022.
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 16835-3:2015.
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, Eston
...

SLOVENSKI STANDARD
oSIST prEN ISO 20186-3:2018
01-marec-2018
0ROHNXODUQHGLDJQRVWLþQHSUHLVNDYHLQYLWUR6SHFLILNDFLMH]DSUHGSUHLVNRYDOQH
SURFHVH]DYHQVNRSROQRNUL&HOLþQD51$GHO,]SOD]PHL]ROLUDQLFLUNXOLUDMRþL
EUH]FHOLþQL'1$ ,62',6
Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes
for venous whole blood - Cellular RNA - Part 3: Isolated circulating cell free DNA from
plasma (ISO/DIS 20186-3:2018)
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für venöse Vollblutproben - Teil 3: Aus Plasma isolierte
zirkulierende zellfreie DNS (ISO/DIS 20186-3:2018)
Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus pré-
analytiques pour le sang - ARN cellulaire - Partie 3: ADN libre circulant extrait du plasma
(ISO/DIS 20186-3:2018)
Ta slovenski standard je istoveten z: prEN ISO 20186-3
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
oSIST prEN ISO 20186-3:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 20186-3:2018

---------------------- Page: 2 ----------------------
oSIST prEN ISO 20186-3:2018
DRAFT INTERNATIONAL STANDARD
ISO/DIS 20186-3
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:
2018-01-03 2018-03-28
Molecular in-vitro diagnostic examinations —
Specifications for pre-examination processes for venous
whole blood — Cellular RNA —
Part 3:
Isolated circulating cell free DNA from plasma
Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus pré-analytiques pour le
sang - ARN cellulaire —
Partie 3: ADN libre circulant extrait du plasma
ICS: 11.100.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 20186-3:2018(E)
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. ISO 2018

---------------------- Page: 3 ----------------------
oSIST prEN ISO 20186-3:2018
ISO/DIS 20186-3:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2018 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 20186-3:2018
ISO/DIS 20186-3:2018(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General Consideration . 5
5 Outside the laboratory .
...

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