SIST EN ISO 20184-3:2021

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)

This document specifies requirements and gives recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. 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.
Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.
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 gefrorene Gewebeproben - Teil 3: Isolierte DNA (ISO 20184-3:2021)

Dieses Dokument legt Anforderungen fest und gibt Empfehlungen zur Handhabung, Lagerung, Verarbeitung und Dokumentation von gefrorenen Gewebeproben, die für die DNA Untersuchung während der präanalytischen Phase vor Beginn der molekularen Untersuchung vorgesehen sind.
Dieses Dokument ist anwendbar auf molekulare in vitro diagnostische Untersuchungen, einschließlich im Laboratorium entwickelter Prüfungen, die von medizinischen Laboratorien und Laboratorien der molekularen Pathologie durchgeführt werden, die aus gefrorenem Gewebe isolierte DNA auswerten. Es ist außerdem dafür vorgesehen, von Kunden des Laboratoriums, Entwicklern und Herstellern von In vitro Diagnostika sowie Biobanken, Einrichtungen und kommerziellen Organisationen, die biomedizinische Forschungen durchführen, und Aufsichtsbehörden angewendet zu werden.
Gewebe, die vor dem Gefriervorgang einer chemischen Vorbehandlung zur Stabilisierung unterzogen wurden, sind nicht durch dieses Dokument abgedeckt.
ANMERKUNG Internationale, nationale oder regionale Bestimmungen bzw. Anforderungen können ebenfalls für bestimmte Themen in diesem Dokument gelten.

Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les tissus congelés - Partie 3: ADN extrait (ISO 20184-3:2021)

Le présent document spécifie des exigences et fournit des recommandations relatives à la manipulation, au stockage, au traitement et à la documentation de prélèvements de tissus congelés destinés à l’analyse de l’ADN durant la phase préanalytique précédant la réalisation d’une analyse moléculaire.
Le présent document s’applique aux analyses de diagnostic moléculaire in vitro, y compris les essais développés en laboratoires, réalisées par les laboratoires de biologie médicale et les laboratoires de pathologie moléculaire qui évaluent l’ADN extrait de tissus congelés. Il est également destiné à être utilisé par les clients de laboratoires, les développeurs et fabricants de l’industrie du diagnostic in vitro, ainsi que par les biobanques, les institutions et les organismes commerciaux spécialisés en recherche biomédicale et les autorités réglementaires.
Le cas des tissus ayant subi un prétraitement de stabilisation chimique avant la congélation n’est pas couvert par le présent document.
NOTE         Des réglementations ou exigences internationales, nationales ou régionales peuvent également s’appliquer à des sujets spécifiques traités dans le présent document.

Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese za zamrznjena tkiva - 3. del: Izolirana DNK (ISO 20184-3:2021)

General Information

• Status: Published
• Public Enquiry End Date: 19-Oct-2020
• Publication Date: 09-Jun-2021
• ICS: 11.100.10 - In vitro diagnostic test systems
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 03-Jun-2021
• Due Date: 08-Aug-2021
• Completion Date: 10-Jun-2021
• Ref Project: EN ISO 20184-3:2021 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)

Relations

• Replaces: SIST-TS CEN/TS 16826-3:2018 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 3: Isolated DNA
• Effective Date: 02-Jun-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2021
Nadomešča:
SIST-TS CEN/TS 16826-3:2018
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese za zamrznjena tkiva - 3. del: Izolirana DNK (ISO 20184-3:2021)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für gefrorene Gewebeproben - Teil 3: Isolierte DNA (ISO 20184-
3:2021)
Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour les tissus congelés - Partie 3: ADN extrait (ISO 20184-3:2021)
Ta slovenski standard je istoveten z: EN ISO 20184-3:2021
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 20184-3
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2021
EUROPÄISCHE NORM
ICS 11.100.10 Supersedes CEN/TS 16826-3:2018
English Version
Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for frozen tissue - Part 3:
Isolated DNA (ISO 20184-3:2021)
Analyses de diagnostic moléculaire in vitro - Molekularanalytische in-vitro-diagnostische Verfahren
Spécifications relatives aux processus préanalytiques - Spezifikationen für präanalytische Prozesse für
pour les tissus congelés - Partie 3: ADN extrait (ISO gefrorene Gewebeproben - Teil 3: Isolierte DNA (ISO
20184-3:2021) 20184-3:2021)
This European Standard was approved by CEN on 9 May 2021.

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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20184-3:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 20184-3:2021) 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 November 2021, and conflicting national standards
shall be withdrawn at the latest by May 2024.
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 16826-3:2018.
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 20184-3:2021 has been approved by CEN as EN ISO 20184-3:2021 without any
modification.
INTERNATIONAL ISO
STANDARD 20184-3
First edition
2021-05
Molecular in vitro diagnostic
examinations — Specifications for
pre-examination processes for frozen
tissue —
Part 3:
Isolated DNA
Analyses de diagnostic moléculaire in vitro — Spécifications relatives
aux processus préanalytiques pour les tissus congelés —
Partie 3: ADN extrait
Reference number
ISO 20184-3:2021(E)
©
ISO 2021
ISO 20184-3:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO 20184-3:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
4 General considerations . 5
5 Outside the laboratory . 6
5.1 Specimen collection . 6
5.1.1 General. 6
5.1.2 Information about the patient/specimen donor . 6
5.1.3 Information about the specimen . 6
5.1.4 Specimen processing . 6
5.2 Fresh tissue transport requirements . 7
5.2.1 General. 7
5.2.2 Preparations for the transport . 7
5.2.3 During transport . 8
6 Inside the laboratory . 8
6.1 Information about the reception of the specimen . 8
6.2 Evaluation of the pathology of the specimen and selection of the sample(s) . 8
6.3 Freezing of the specimen or sample(s) . 9
6.4 Storage requirements .11
6.5 DNA isolation .11
6.5.1 General.11
6.5.2 Using commercial kits .12
6.5.3 Using laboratory developed protocols .12
6.6 Quantity and quality assessment of isolated DNA .12
6.7 Storage of isolated DNA .13
Bibliography .14
ISO 20184-3:2021(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
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
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
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in
vitro diagnostic test systems, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 140, In vitro diagnostic medical devices, in accordance with the Agreement
on technical cooperation between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 20184 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.
iv © ISO 2021 – All rights reserved

ISO 20184-3:2021(E)
Introduction
Molecular in vitro diagnostics, including molecular pathology, has enabled significant progress in
medicine. Further progress is expected with new technologies analysing nucleic acids, proteins, and
metabolites in human tissues and body fluids. Ho
...