EN ISO 20184-2:2018

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018)

This document gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for the examination of isolated proteins during the pre-examination phase before a molecular assay is performed.
This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate proteins isolated from frozen tissue. 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.
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 2: Isolierte Proteine (ISO 20184-2:2018)

Diese Internationale Norm gibt Empfehlungen zur Handhabung, Dokumentation, Lagerung und Verarbeitung von aus gefrorenem Gewebe bestehenden und für die Untersuchung vorgesehenen isolierten Proteinen während der präanalytischen Phase vor Beginn der molekularen Analyse. Diese Internationale Norm ist anwendbar auf molekulare in-vitro-Diagnoseuntersuchungen, die von medizinisches Laboratorien und Laboratorien der molekularen Pathologie durchgeführt werden, die aus gefrorenem Gewebe isolierten Proteine auswerten. Sie hat außerdem den Zweck, von Kunden des Laboratoriums, Entwicklern der in-vitro-Diagnose und Herstellern sowie Institutionen und kommerziellen Organisationen, die biomedizinische Forschungen durchführen, und Biobanken und Arzneimittelagenturen verwendet zu werden.
Proteinprofile und Protein-Protein-Interaktionen in Geweben können sich vor der Probenahme (z. B. aufgrund von warmer Ischämie) und nach der Probenahme (z. B. aufgrund von kalter Ischämie) drastisch verändern. Die Veränderungen werden beispielsweise durch Geninduktion, die Herabregelung von Genen oder eine Protein-Degradation verursacht. Die Mengen der Proteinspezies können sich je nach Gewebespender/Patient unterschiedlich verändern. Die Genexpression kann durch die jeweilige Behandlung oder den Eingriff (Operation, Biopsie) oder die zur Anästhesie oder Behandlung von Begleiterkrankungen verabreichten Medikamente sowie abhängig von unterschiedlichen Umgebungsbedingungen nach der Gewebeentnahme aus dem Körper beeinflusst sein.
Daher ist es äußerst wichtig, dass besondere Maßnahmen getroffen werden, um die beschriebenen Proteinprofilveränderungen und -modifikationen im Gewebe für die anschließende Untersuchung möglichst gering zu halten.
Gewebe, die vor dem Gefriervorgang einer chemischen Vorbehandlung zur Stabilisierung unterzogen wurden, sind nicht durch dieses Dokument abgedeckt. Des Weiteren gilt dieses Dokument nicht für eine immunhistochemische Proteinuntersuchung.
ANMERKUNG   Internationale, nationale oder regionale Regelungen bzw. Anforderungen können ebenfalls für bestimmte Themen in dieser Internationalen Norm gelten.

Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les tissus congelés - Partie 2: Protéines extraites (ISO 20184-2:2018)

Le présent document fournit des lignes directrices concernant la manipulation, la documentation, le stockage et le traitement de prélèvements de tissus congelés destinés à l'analyse des protéines extraites, durant la phase préanalytique précédant la réalisation d'un essai moléculaire.
Le présent document s'applique aux analyses de diagnostic moléculaire in vitro réalisées par des laboratoires de biologie médicale et des laboratoires de pathologie moléculaire qui évaluent les protéines extraites de tissus congelés. Il est également destiné à être utilisé par des clients de laboratoires, des développeurs et fabricants de l'industrie du diagnostic in vitro, ainsi que par des biobanques, des institutions et des organismes commerciaux spécialisés en recherche biomédicale, de même que des autorités de réglementation.
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 - 2. del: Izolirani proteini (ISO 20184-2:2018)

Ta mednarodni standard vsebuje priporočila za obravnavo, dokumentiranje, shranjevanje in obdelavo vzorcev zamrznjenih tkiv, namenjenih za preiskavo izvlečka proteinov med predpreiskovalno fazo, preden se izvede molekularni preskus. Ta mednarodni standard se uporablja za molekularne diagnostične preiskave in vitro, vključno z laboratorijsko razvitimi preskusi, ki jih izvajajo v medicinskih laboratorijih.  Uporabljali naj bi ga tudi uporabniki laboratorijev, razvijalci in proizvajalci diagnostike in vitro, nanaša pa se tudi na institucije in komercialne organizacije, ki izvajajo biomedicinske raziskave, biobanke ter regulativne organe.  Profili proteinov in interakcije protein-protein v tkivih se lahko pred zbiranjem tkiva (npr. zaradi tople ishemije) in po zbiranju tkiva (npr. zaradi hladne ishemije) zelo spremenijo. Spremembe so na primer posledica genske indukcije, znižanja izražanja gena, razgradnje proteina. Količine vrst proteinov se lahko različno spreminjajo pri tkivih različnih darovalcev/bolnikov. Na izražanje genov je mogoče vplivati z zdravljenjem ali posegom (operacija, biopsija), anestetiki ali celo z zdravljenjem sočasne bolezni kot tudi z različnimi okoljskimi pogoji po odstranitvi tkiva iz telesa. Zato je nujno treba sprejeti posebne ukrepe, da se zmanjšajo opisane spremembe profila proteina v tkivu za nadaljnje preiskave. Tkiva, ki so pred zamrzovanjem prestala predobdelavo za kemično stabilizacijo, niso zajeta v tem dokumentu. Ta dokument se ne uporablja za preiskave proteinov z imunohistokemijo. OPOMBA:   Za določene teme, ki so zajete v tem mednarodnem standardu, lahko veljajo tudi mednarodni, nacionalni ali regionalni predpisi ali zahteve.

General Information

• Status: Published
• Publication Date: 11-Dec-2018
• Withdrawal Date: 30-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: 12-Dec-2018
• Due Date: 11-Aug-2018
• Completion Date: 12-Dec-2018
• Ref Project: SIST EN ISO 20184-2:2019 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018)

Relations

• Replaces: CEN/TS 16826-2:2015 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 2: Isolated proteins
• Effective Date: 19-Dec-2018

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2019
1DGRPHãþD
SIST-TS CEN/TS 16826-2:2015
0ROHNXODUQHGLDJQRVWLþQHSUHLVNDYHLQYLWUR6SHFLILNDFLMH]DSUHGSUHLVNRYDOQH
SURFHVH]D]DPU]QMHQDWNLYDGHO,]ROLUDQLSURWHLQL,62
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018)
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für schockgefrorene Gewebeproben - Teil 2: Isolierte Proteine
(ISO 20184-2:2018)
Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour les tissus congelés - Partie 2: Protéines extraites (ISO 20184-
2:2018)
Ta slovenski standard je istoveten z: EN ISO 20184-2:2018
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 20184-2
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2018
EUROPÄISCHE NORM
ICS 11.100.10 Supersedes CEN/TS 16826-2:2015
English Version
Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for frozen tissue - Part 2:
Isolated proteins (ISO 20184-2:2018)
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 2: Protéines extraites schockgefrorene Gewebeproben - Teil 2: Isolierte
(ISO 20184-2:2018) Proteine (ISO 20184-2:2018)
This European Standard was approved by CEN on 30 September 2018.

This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 30 January 2019.

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, 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 NORMALISATIO N

EUROPÄISCHES KOMITEE FÜR NORMUN G

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. EN ISO 20184-2:2018 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 20184-2:2018) 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 June 2019, and conflicting national standards shall be
withdrawn at the latest by December 2021.
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 16826-2:2015.
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, 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 the United Kingdom.
Endorsement notice
The text of ISO 20184-2:2018 has been approved by CEN as EN ISO 20184-2:2018 without any
modification.
INTERNATIONAL ISO
STANDARD 20184-2
First edition
2018-11
Molecular in vitro diagnostic
examinations — Specifications for
pre-examination processes for frozen
tissue —
Part 2:
Isolated proteins
Analyses de diagnostic moléculaire in vitro — Spécifications relatives
aux processus préanalytiques pour les tissus congelés —
Partie 2: Protéines extraites
Reference number
ISO 20184-2:2018(E)
©
ISO 2018
ISO 20184-2:2018(E)
© ISO 2018
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
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Published in Switzerland
ii © ISO 2018 – All rights reserved

ISO 20184-2:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
4 General considerations . 4
5 Outside the laboratory . 5
5.1 Specimen collection . 5
5.1.1 General. 5
5.1.2 Information about the specimen donor/patient . 5
5.1.3 Information about the specimen . 6
5.1.4 Specimen processing . 6
5.2 Fresh tissue transport requirements . 6
5.2.1 General. 6
5.2.2 Preparations for the transport . 7
5.2.3 During transport . 7
6 Inside the laboratory . 7
6.1 Information about the reception of the specimen . 7
6.2 Evaluation of the pathology of the specimen and selection of the sample(s) . 7
6.3 Freezing of the specimen or sample(s) . 8
6.4 Storage requirements .10
6.5 Isolation of total protein .10
6.5.1 General.10
6.5.2 Using commercial kits .11
6.5.3 Using the laboratories own protocols .11
6.6 Quantity and quality assessment of isolated proteins .11
6.7 Storage of isolated total protein .12
Annex A (informative) Quantitative protein examination demonstrates changes of protein
amounts during cold ischemia .13
Bibliography .17
ISO 20184-2:2018(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
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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
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.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in
vitro diagnostic test systems.
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 2018 – All rights reserved

ISO 20184-2:2018(E
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