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SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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, 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 20186-3:2019 has been approved by CEN as EN ISO 20186-3:2019 without any
modification.
INTERNATIONAL ISO
STANDARD 20186-3
First edition
2019-09
Molecular in vitro diagnostic
examinations — Specifications for
pre-examination processes for venous
whole blood —
Part 3:
Isolated circulating cell free DNA
from plasma
Analyses de diagnostic moléculaire in vitro — Spécifications relatives
aux processus préanalytiques pour le sang total veineux —
Partie 3: ADN libre circulant extrait du plasma
Reference number
ISO 20186-3:2019(E)
©
ISO 2019
ISO 20186-3:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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ISO 20186-3:2019(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 . 5
5.1 Specimen collection . 5
5.1.1 Information about the specimen donor/patient . 5
5.1.2 Selection of the venous whole blood collection tube by the laboratory . 6
5.1.3 Venous whole blood collection from the donor/patient and stabilization
procedures . 6
5.1.4 Information about the specimen and storage requirements at the blood
collection facility . 7
5.2 Transport requirements . 7
6 Inside the laboratory . 8
6.1 Specimen reception . 8
6.2 Storage requirements for blood specimens . 8
6.3 Plasma preparation . 9
6.4 Storage requirements for plasma samples . 9
6.5 Isolation of the ccfDNA .10
6.5.1 General.10
6.5.2 Using blood collection tubes with stabilizers .10
6.5.3 Using blood collection tubes without stabilizers .11
6.6 Quantity and quality assessment of isolated ccfDNA .11
6.7 Storage of isolated ccfDNA .11
6.7.1 General.11
6.7.2 ccfDNA isolated with commercially available kits .12
6.7.3 ccfDNA isolated with the laboratory's own protocols .12
Annex A (informative) Impact of pre-examination process steps on circulating cell free DNA
profiles in venous whole blood plasma .13
Bibliography .16
ISO 20186-3:2019(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
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ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
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This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in
vitro diagnostic test systems.
A list of all parts in the ISO 20186 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
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