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EN ISO 20184-3:2021

(Main)

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (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
Publication Date
25-May-2021
ICS
11.100.10 - In vitro diagnostic test systems
Technical Committee
CEN/TC 140 - In vitro diagnostic systems
Drafting Committee
CEN/TC 140/WG 3 - Quality management in the medical laboratory
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
26-May-2021
Completion Date
26-May-2021
Ref Project
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)

Relations

Replaces
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
08-Jun-2022

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SLOVENSKI STANDARD
SIST EN ISO 20184-3:2021
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
SIST EN ISO 20184-3:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 20184-3:2021

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SIST EN ISO 20184-3:2021


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.

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SIST EN ISO 20184-3:2021
EN ISO 20184-3:2021 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 20184-3:2021
EN ISO 20184-3:2021 (E)
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, Spa
...

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