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CEN/TS 16826-3:2018

(Main)

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 3: Isolated DNA

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 3: Isolated DNA

This document 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 examination 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 schockgefrorene Gewebeproben - Teil 3: Isolierte DNA

Dieses Dokument gibt Empfehlungen zur Handhabung, Lagerung, Verarbeitung und Dokumentation von aus gefrorenem Gewebe bestehendem und für die DNA-Untersuchung vorgesehenem Untersuchungsmaterial während der präanalytischen Phase vor Beginn der molekularen Untersuchung.
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 biomedi-zinische 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.

Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les tissus à congélation rapide - Partie 3: ADN isolé

Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese za hitro zamrznjena tkiva - 3. del: Izolirani DNA

Ta dokument podaja priporočila za obravnavo, shranjevanje, obdelavo in dokumentiranje vzorcev zamrznjenih tkiv, namenjenih za analizo DNK med predpreiskovalno fazo, preden se izvede molekularna preiskava.
Ta dokument se uporablja za molekularne diagnostične preiskave in vitro, vključno z laboratorijsko razvitimi testi, ki jih izvajajo medicinski laboratoriji in laboratoriji za molekularno patologijo, ki ocenjujejo DNK, izoliran iz zamrznjenega tkiva. Namenjen je tudi temu, da ga uporabljajo laboratorijske stranke, razvijalci in proizvajalci diagnostike in vitro, biobanke, institucije in komercialne organizacije, ki izvajajo biomedicinske raziskave, in regulativni organi.
Tkiva, ki so pred zamrzovanjem prestala predobdelavo za kemično stabilizacijo, niso zajeta v tem dokumentu.
OPOMBA: Za določene teme, ki so zajete v tem dokumentu, lahko veljajo tudi mednarodni, nacionalni ali regionalni predpisi ali zahteve.

General Information

Status
Withdrawn
Publication Date
17-Jul-2018
Withdrawal 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
9960 - Withdrawal effective - Withdrawal
Completion Date
26-May-2021
Ref Project
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

Relations

Replaced By
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)
Effective Date
08-Jun-2022

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN/TS 16826-3:2018
01-september-2018
0ROHNXODUQHGLDJQRVWLþQHSUHLVNDYHLQYLWUR6SHFLILNDFLMH]DSUHGSUHLVNRYDOQH
SURFHVH]DKLWUR]DPU]QMHQDWNLYDGHO,]ROLUDQL'1$
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for snap frozen tissue - Part 3: Isolated DNA
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für schockgefrorene Gewebeproben - Teil 1: Isolierte DNA
Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour les tissus à congélation rapide - Partie 3: ADN isolé
Ta slovenski standard je istoveten z: CEN/TS 16826-3:2018
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST-TS CEN/TS 16826-3:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN/TS 16826-3:2018

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SIST-TS CEN/TS 16826-3:2018


CEN/TS 16826-3
TECHNICAL SPECIFICATION

SPÉCIFICATION TECHNIQUE

July 2018
TECHNISCHE SPEZIFIKATION
ICS 11.100.10
English Version

Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for snap frozen tissue - Part
3: Isolated DNA
Tests de diagnostic moléculaire in vitro - Spécifications Molekularanalytische in-vitro-diagnostische Verfahren
relatives aux processus préanalytiques pour les tissus à - Spezifikationen für präanalytische Prozesse für
congélation rapide - Partie 3: ADN isolé schockgefrorene Gewebeproben - Teil 3: Isolierte DNA
This Technical Specification (CEN/TS) was approved by CEN on 16 April 2018 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

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
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 16826-3:2018 E
worldwide for CEN national Members.

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SIST-TS CEN/TS 16826-3:2018
CEN/TS 16826-3:2018 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General considerations . 9
5 Outside the laboratory . 9
5.1 Specimen collection . 9
5.1.1 General . 9
5.1.2 Information about the specimen donor/patient . 9
5.1.3 Information about the specim
...

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