Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA

This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs) intended for RNA 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 examine RNA 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 in EN ISO 20184-1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA and EN ISO 20166-1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA.
This document is not applicable for RNA 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 Feinnadelaspiration (FNA) - Teil 1: Isolierte zelluläre RNA

Dieses Dokument gibt Leitlinien für die Handhabung, Dokumentation, Lagerung und Verarbeitung von Feinnadelaspiraten (FNAs) zur RNA Untersuchung während der präanalytischen Phase vor Beginn der molekularen Analyse.
Dieses Dokument ist anzuwenden 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 RNA 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 angewendet 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 1, Molekularanalytische in vitro-diagnostische Verfahren — Spezifikationen für präanalytische Prozesse für gefrorene Gewebeproben — Teil 1: Isolierte RNA und EN ISO 20166 1, Molekularanalytische in vitro-diagnostische Verfahren — Spezifikationen für präanalytische Prozesse für formalinfixierte und paraffineingebettete (FFPE)-Gewebeproben — Teil 1: Isolierte RNA behandelt werden.
Dieses Dokument ist nicht anzuwenden für RNA Untersuchungen durch In situ-Detektion.
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 1 : ARN cellulaire extrait

Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese pri aspiraciji s tanko iglo (FNA) - 1. del: Izolirana celična RNK

Ta dokument podaja smernice za obravnavo, dokumentiranje, shranjevanje in obdelavo aspiratov, pridobljenih z aspiracijsko biopsijo s tanko iglo (FNA), namenjenih za pregled RNK 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 RNK, 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 (FNA B) se uporabljajo drugačni namenski ukrepi, ki niso zajeti v tem dokumentu, temveč v standardih ISO 20184-1, Molekularne diagnostične preiskave in vitro – Specifikacije za predpreiskovalne procese za zamrznjena tkiva – 1. del: Izolirani RNK in ISO 20166-1, Molekularne diagnostične preiskave in vitro – Specifikacije za predpreiskovalne procese za tkiva, ki so fiksirana v formalinu ter položena v parafin – 1. del: Izolirani RNK.
RNK v patogenih v aspiratu ni 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
Published
Publication Date
21-Dec-2021
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
22-Dec-2021
Due Date
01-Dec-2020
Completion Date
22-Dec-2021

Buy Standard

Technical specification
TS CEN/TS 17688-1:2022 - BARVE
English language
38 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day
Draft
kTS FprCEN/TS 17688-1:2021 - BARVE
English language
38 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN/TS 17688-1:2022
01-februar-2022
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese pri aspiraciji s tanko iglo (FNA) - 1. del: Izolirana celična RNK
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA
Molekularanalytische in‐vitro‐diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für Feinnadelaspiration (FNA) - Teil 1: Isolierte zelluläre RNA
Analyses moléculaires de diagnostic in vitro - Spécifications pour les processus
préanalytiques pour les ponctions à l’aiguille fine - Partie 1 : ARN cellulaire extrait
Ta slovenski standard je istoveten z: CEN/TS 17688-1:2021
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
SIST-TS CEN/TS 17688-1:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST-TS CEN/TS 17688-1:2022

---------------------- Page: 2 ----------------------
SIST-TS CEN/TS 17688-1:2022


CEN/TS 17688-1
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 1: Isolated cellular RNA
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 1 : ARN cellulaire Feinnadelaspiration (FNA) - Teil 1: Isolierte zelluläre
extrait RNA
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 17688-1:2021 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST-TS CEN/TS 17688-1:2022
CEN/TS 17688-1:2021 (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 .
...

SLOVENSKI STANDARD
kSIST-TS FprCEN/TS 17688-1:2021
01-september-2021
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese pri aspiraciji s tanko iglo (FNA) - 1. del: Izolirana celična RNK
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA
Molekularanalytische in‐vitro‐diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für Feinnadelaspiration (FNA) - Teil 1: Isolierte zelluläre RNA
Analyses moléculaires de diagnostic in vitro - Spécifications pour les processus
préanalytiques pour les ponctions à l’aiguille fine - Partie 1 : ARN cellulaire extrait
Ta slovenski standard je istoveten z: FprCEN/TS 17688-1
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
kSIST-TS FprCEN/TS 17688-1:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
kSIST-TS FprCEN/TS 17688-1:2021

---------------------- Page: 2 ----------------------
kSIST-TS FprCEN/TS 17688-1:2021


FINAL DRAFT
TECHNICAL SPECIFICATION
FprCEN/TS 17688-1
SPÉCIFICATION TECHNIQUE

TECHNISCHE SPEZIFIKATION

July 2021
ICS 11.100.10
English Version

Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for Fine Needle Aspirates
(FNAs) - Part 1: Isolated cellular RNA
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 1 : ARN cellulaire Feinnadelaspiration (FNA) - Teil 1: Isolierte zelluläre
extrait RNA


This draft Technical Specification is submitted to CEN members for Vote. It has been drawn up by the Technical Committee
CEN/TC 140.

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.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a Technical Specification. It is distributed for review and comments. It is subject to change
without notice and shall not be referred to as a Technical Specification.


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. FprCEN/TS 17688-1:2021 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
kSIST-TS FprCEN/TS 17688-1:2021
FprCEN/TS 17688-1:2021 (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 . 13
5.1.3 Information about the specimen .
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.