Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019)

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for genomic DNA examination during the pre-examination phase before a molecular examination 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 cell free circulating DNA, which are not described in this document.
NOTE       Circulating cell free DNA in blood is covered in ISO 20186-3.
Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document.
This document does not cover the isolation of specific blood cells and subsequent isolation of genomic DNA therefrom.
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 2: Isolierte genomische DNA (ISO 20186-2:2019)

Diese Internationale Norm gibt Empfehlungen zur Handhabung, Dokumentation, Lagerung und Verarbeitung von Proben venösen Vollbluts, die für die Untersuchung genomischer DNA vorgesehen sind, während der präanalytischen Phase vor der Durchführung einer molekularen Untersuchung. Diese Internationale Norm betrifft Proben, die mit Blutentnahmeröhrchen für venöses Vollblut entnommen wurden.
Diese Internationale Norm ist anwendbar auf alle molekularen in vitro diagnostischen Untersuchungen, die in medizinischen Laboratorien durchgeführt werden. Sie ist darüber hinaus für die Verwendung durch Kunden von Laboratorien, Entwickler und Hersteller von In vitro Diagnostika, durch Institutionen und kommerzielle Organisationen, die biomedizinische Forschungen durchführen, sowie durch Biobanken und Arzneimittelagenturen bestimmt.
Zur Stabilisierung von blutzellfreier zirkulierender DNA sind andere spezielle Maßnahmen erforderlich, die in dieser Internationalen Norm nicht beschrieben werden. Zellfrei im Blut zirkulierende DNA wird behandelt in ISO 20186 3, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma.
Auch bei der Abnahme, Stabilisierung, dem Transport und der Lagerung von Kapillarblut sowie für die Gewinnung und Lagerung von Blut mithilfe von papierbasierten Techniken sowie anderen Techniken zur Herstellung von getrocknetem Blut sind verschiedene spezielle Maßnahmen nötig. Diese werden in dieser Internationalen Norm ebenfalls nicht beschrieben.
Diese Internationale Norm behandelt nicht die Isolierung von bestimmten Blutzellen und die anschließende Präparation von genomischer DNA aus diesen Zellen.
Auch DNA von im Blut vorliegenden Pathogenen wird in dieser Internationalen Norm nicht behandelt.
ANMERKUNG   Internationale, nationale oder regionale Regelungen bzw. Anforderungen können ebenfalls für bestimmte Themen in dieser Internationalen Norm gelten.

Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour le sang total veineux - Partie 2: ADN génomique extrait (ISO 20186-2:2019)

Le présent document fournit des lignes directrices pour la manipulation, le stockage, le traitement et la documentation des prélèvements de sang total veineux destinés à l'analyse de l'ADN génomique durant la phase préanalytique précédant la réalisation d'une analyse moléculaire. 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 à prendre pour stabiliser l'ADN libre circulant dans le sang.
NOTE       L'ADN libre circulant dans le sang est traité dans l'ISO 20186‑3.
Des mesures spécifiques différentes sont prises pour prélever, stabiliser, transporter et stocker le sang capillaire, et pour prélever et stocker le sang par des technologies à base de support papier ou d'autres technologies produisant du sang séché. Ces mesures ne sont pas décrites dans le présent document.
Le présent document ne traite ni de l'extraction de cellules sanguines spécifiques ni de l'extraction de l'ADN génomique qu'elles contiennent.
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 - 2. del: Iz genoma izolirana DNK (ISO 20186-2:2019)

Ta mednarodni standard vsebuje priporočila za obravnavo, dokumentiranje, shranjevanje in obdelavo vzorcev venske polne krvi, namenjenih za analizo iz genoma izolirane DNA 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 na primer izvajajo v medicinskih laboratorijih. Uporabljali naj bi ga tudi uporabniki laboratorijev, razvijalci in proizvajalci diagnostike in vitro, nanaša pa se tudi na institucije in komercialne organizacije, ki izvajajo biomedicinske raziskave, biobanke ter regulativne organe. Krvna genomska DNA lahko po odvzemu krvi razpade ali se razkroji. Zato je treba uporabiti posebne ukrepe za pridobivanje vzorcev krvi dobre kakovosti za analizo genomske DNA. To je še posebej pomembno za analitične preskusne postopke, ki zahtevajo DNA z veliko molekularno težo. Za ohranjanje cirkulirajoče brezcelične DNA je treba uporabiti drugačne namenske ukrepe, ki niso opisani v tem mednarodnem standardu. Cirkulirajoča brezcelična DNA je opisana v standardu ISO 20091-3, Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese za vensko polno kri - 3. del: Iz plazme izolirana cirkulirajoča brezcelična DNA Za zbiranje, stabiliziranje, prevoz in shrambo kapilarne krvi ter za zbiranje in shrambo krvi s tehnologijami, ki temeljijo na papirju, ali drugimi tehnologijami, pri katerih nastaja posušena kri, je treba uporabiti drugačne namenske ukrepe. Ti niso opisani v tem mednarodnem standardu. Patogena DNA v krvi ni zajeta 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
26-Mar-2019
Withdrawal Date
30-Mar-2022
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
27-Mar-2019
Due Date
11-Aug-2018
Completion Date
27-Mar-2019

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 20186-2:2019
01-julij-2019
Nadomešča:
SIST-TS CEN/TS 16835-2:2015
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese za vensko polno kri - 2. del: Iz genoma izolirana DNA (ISO 20186-2:2019)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019)
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für venöse Vollblutproben - Teil 2: Isolierte genomische DNA
(ISO 20186-2:2019)
Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour le sang total veineux - Partie 2: ARN cellulaire extrait (ISO 20186-
2:2019)
Ta slovenski standard je istoveten z: EN ISO 20186-2:2019
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
11.100.30 Analiza krvi in urina Analysis of blood and urine
SIST EN ISO 20186-2:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 20186-2:2019

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

SIST EN ISO 20186-2:2019


EN ISO 20186-2
EUROPEAN STANDARD

NORME EUROPÉENNE

March 2019
EUROPÄISCHE NORM
ICS 11.100.10 Supersedes CEN/TS 16835-2:2015
English Version

Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for venous whole blood -
Part 2: Isolated genomic DNA (ISO 20186-2:2019)
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 2: ADN génomique venöse Vollblutproben - Teil 2: Isolierte genomische
extrait (ISO 20186-2:2019) DNA (ISO 20186-2:2019)
This European Standard was approved by CEN on 2 February 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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 20186-2:2019 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 20186-2:2019
EN ISO 20186-2:2019 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------

SIST EN ISO 20186-2:2019
EN ISO 20186-2:2019 (E)
European foreword
This document (EN ISO 20186-2:2019) 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 September 2019, and conflicting national standards
shall be withdrawn at the latest by March 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 16835-2:2015.
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, Estonia, Finland, Former Yugoslav Republic of Macedonia,
Fra
...

SLOVENSKI STANDARD
SIST EN ISO 20186-2:2019
01-julij-2019
Nadomešča:
SIST-TS CEN/TS 16835-2:2015
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese za vensko polno kri - 2. del: Iz genoma izolirana DNK (ISO 20186-2:2019)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019)
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für venöse Vollblutproben - Teil 2: Isolierte genomische DNA
(ISO 20186-2:2019)
Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour le sang total veineux - Partie 2: ARN cellulaire extrait (ISO 20186-
2:2019)
Ta slovenski standard je istoveten z: EN ISO 20186-2:2019
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
11.100.30 Analiza krvi in urina Analysis of blood and urine
SIST EN ISO 20186-2:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 20186-2:2019

---------------------- Page: 2 ----------------------
SIST EN ISO 20186-2:2019


EN ISO 20186-2
EUROPEAN STANDARD

NORME EUROPÉENNE

March 2019
EUROPÄISCHE NORM
ICS 11.100.10 Supersedes CEN/TS 16835-2:2015
English Version

Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for venous whole blood -
Part 2: Isolated genomic DNA (ISO 20186-2:2019)
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 2: ADN génomique venöse Vollblutproben - Teil 2: Isolierte genomische
extrait (ISO 20186-2:2019) DNA (ISO 20186-2:2019)
This European Standard was approved by CEN on 2 February 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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 20186-2:2019 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST EN ISO 20186-2:2019
EN ISO 20186-2:2019 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------
SIST EN ISO 20186-2:2019
EN ISO 20186-2:2019 (E)
European foreword
This document (EN ISO 20186-2:2019) 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 September 2019, and conflicting national standards
shall be withdrawn at the latest by March 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 16835-2:2015.
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, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Ger
...

SLOVENSKI STANDARD
oSIST prEN ISO 20186-2:2017
01-februar-2017
0ROHNXODUQHGLDJQRVWLþQHSUHLVNDYHLQYLWUR6SHFLILNDFLMH]DSUHGSUHLVNRYDOQH
SURFHVH]DYHQVNRSROQRNULGHO'1$L]ROLUDQL]JHQRPD ,62',6

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for venous whole blood - Part 2: Isolated genomic DNA correct (ISO/DIS 20186-2:2016)
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für venöse Vollblutproben - Teil 2: Isolierte genomische DNA
(ISO/DIS 20186-2:2016)
Ta slovenski standard je istoveten z: prEN ISO 20186-2
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
oSIST prEN ISO 20186-2:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 20186-2:2017

---------------------- Page: 2 ----------------------
oSIST prEN ISO 20186-2:2017
DRAFT INTERNATIONAL STANDARD
ISO/DIS 20186-2
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:
2016-12-23 2017-03-16
Molecular in vitro diagnostic examinations —
Specifications for pre-examination processes for venous
whole blood —
Part 2:
Isolated genomic DNA correct
Titre manque
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 20186-2:2016(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 2016

---------------------- Page: 3 ----------------------
oSIST prEN ISO 20186-2:2017
ISO/DIS 20186-2:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, 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 2016 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 20186-2:2017
ISO/DIS 20186-2:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope.1
2 Normative references .1
3 Terms and definitions.1
4 General Considerations .6
5 Outside the laboratory .6
5.1 Specimen collection .6
5.1.1 Information about the specimen donor/patient .6
5.1.2 Selection of the venous whole blood collection tube by the laboratory .7
5.1.3 Venous whole blood specimen collection from the donor/patient and stabilization
procedures .7
5.1.4 Information about the specimen and storage requirements at the blood collection facility .7
5.2 Transport requirements .8
6 Inside the laboratory .
...

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