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CEN/TS 17688-3:2021

(Main)

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA

This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs) intended for gDNA 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 examine gDNA isolated from FNAs. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for collecting, stabilizing, transporting and storing of core needle biopsies (FNA Biopsy or FNA B) and are not covered in this document, but EN ISO 20184-3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA and EN ISO 20166-3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA.
This document is not applicable for pathogen DNA examination and gDNA examination by in situ detection.
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 Feinnadelaspirate - Teil 3: Isolierte genomische DNA

Dieses Dokument enthält Leitlinien zur Handhabung, Dokumentation, Lagerung und Verarbeitung von Feinnadelaspiraten (FNAs) zur gDNA Untersuchung während der präanalytischen Phase vor Beginn der molekularen Analyse.
Dieses Dokument gilt für molekulare in vitro-diagnostische Untersuchungen, wozu auch laboreigene Prüfungen zählen, die von medizinischen Laboratorien und Laboratorien der molekularen Pathologie zur Untersuchung der aus FNAs isolierten gDNA durchgeführt werden. Es soll auch von Laborkunden, Entwicklern und Herstellern von In vitro-Diagnostika, Biobanken, Einrichtungen und kommerziellen Organisationen, die in der biomedizinischen Forschung tätig sind, sowie Aufsichtsbehörden eingesetzt werden.
Für die Entnahme, die Stabilisierung, den Transport und die Lagerung von Stanzbiopsien (FNA Biopsie oder FNA B) werden verschiedene spezielle Maßnahmen ergriffen, die nicht in diesem Dokument, sondern in EN ISO 20184 3 Molekularanalytische in vitro-diagnostische Verfahren — Spezifikationen für präanalytische Prozesse für gefrorene Gewebeproben — Teil 3: Isolierte DNA und EN ISO 20166 3 Molekularanalytische in vitro-diagnostische Verfahren — Spezifikationen für präanalytische Prozesse für formalinfixierte und paraffineingebettete (FFPE)-Gewebeproben — Teil 3: Isolierte DNA behandelt werden.
Dieses Dokument findet keine Anwendung auf Untersuchungen pathogener DNA und gDNA Untersuchungen durch In situ-Nachweis.
ANMERKUNG   Zu bestimmten Bereichen, die in diesem Dokument behandelt werden, können auch internationale, nationale oder regionale Bestimmungen oder Anforderungen gelten.

Analyses moléculaires de diagnostic in vitro - Spécifications pour les processus préanalytiques pour les ponctions à l'aiguille fine - Partie 3: ADN génomique isolé

Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese pri aspiraciji s tanko iglo (FNA) - 3. del: Iz genoma izolirana DNK

Ta dokument podaja smernice za obravnavo, dokumentiranje, shranjevanje in obdelavo aspiratov, pridobljenih z aspiracijsko biopsijo s tanko iglo (FNA), namenjenih za pregled gDNK med predpreiskovalno fazo, preden se izvede molekularna preiskava.
Ta dokument se uporablja za molekularne diagnostične preiskave in vitro, vključno z laboratorijsko razvitimi preskusi, ki jih izvajajo v medicinskih laboratorijih in laboratorijih za molekularno patologijo, kjer preiskujejo gDNK, izolirano iz aspiratov, pridobljenih z aspiracijsko biopsijo s tanko iglo. Namenjen je tudi temu, da ga uporabljajo laboratorijske stranke, razvijalci in proizvajalci diagnostike in vitro, biobanke, institucije in komercialne organizacije, ki izvajajo biomedicinske raziskave, ter regulativni organi.
Za zbiranje, stabiliziranje, prevoz in shrambo aspiratov, pridobljenih z aspiracijsko biopsijo z debelo iglo (biopsija FNA oz. FNA B) se uporabljajo drugačni namenski ukrepi, ki niso zajeti v tem dokumentu, temveč v standardih EN ISO 20184-3, Molekularne diagnostične preiskave in vitro – Specifikacije za predpreiskovalne procese za zamrznjena tkiva – 3. del: Izolirana DNK in EN ISO 20166-3, Molekularne diagnostične preiskave in vitro – Specifikacije za predpreiskovalne procese za tkiva, ki so fiksirana v formalinu ter položena v parafin – 3. del: Izolirana DNK.
Ta dokument se ne uporablja za preiskave patogene DNK in preiskave gDNK z odkrivanjem in situ.
OPOMBA:   Za določene teme, ki so zajete v tem dokumentu, lahko veljajo tudi mednarodni, nacionalni ali regionalni predpisi ali zahteve.

General Information

Status
Published
Publication Date
21-Dec-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
22-Dec-2021
Due Date
01-Dec-2020
Completion Date
22-Dec-2021
Ref Project
SIST-TS CEN/TS 17688-3:2022 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA

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SLOVENSKI STANDARD
SIST-TS CEN/TS 17688-3:2022
01-februar-2022
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese pri aspiraciji s tanko iglo (FNA) - 3. del: Iz genoma izolirana DNK
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA
Molekularanalytische in‐vitro‐diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für Feinnadelaspirate - Teil 3: Isolierte genomische DNA
Analyses moléculaires de diagnostic in vitro - Spécifications pour les processus
préanalytiques pour les ponctions à l'aiguille fine - Partie 3: ADN génomique isolé
Ta slovenski standard je istoveten z: CEN/TS 17688-3:2021
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
SIST-TS CEN/TS 17688-3:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN/TS 17688-3:2022

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SIST-TS CEN/TS 17688-3:2022


CEN/TS 17688-3
TECHNICAL SPECIFICATION

SPÉCIFICATION TECHNIQUE

December 2021
TECHNISCHE SPEZIFIKATION
ICS 11.100.10
English Version

Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for Fine Needle Aspirates
(FNAs) - Part 3: Isolated genomic DNA
Analyses moléculaires de diagnostic in vitro - Molekularanalytische in-vitro-diagnostische Verfahren
Spécifications pour les processus préanalytiques pour - Spezifikationen für präanalytische Prozesse für
les ponctions à l'aiguille fine - Partie 3: ADN génomique Feinnadelaspirate - Teil 3: Isolierte genomische DNA
isolé
This Technical Specification (CEN/TS) was approved by CEN on 15 November 2021 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, 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. CEN/TS 17688-3:2021 E
worldwide for CEN national Members.

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SIST-TS CEN/TS 17688-3:2022
CEN/TS 17688-3:2021 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 General considerations . 12
5 Outside the laboratory . 13
5.1 Specimen collection . 13
5.1.1 General . 13
5.1.2 Information about the patient/specimen donor .
...

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