EN ISO 20166-4:2021
(Main)Molecular in vitro diagnostic examinations - Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4: In situ detection techniques (ISO 20166-4:2021)
Molecular in vitro diagnostic examinations - Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4: In situ detection techniques (ISO 20166-4:2021)
This document specifies requirements and gives recommendations for the collection, handling, documentation, transport, storage and processing during the pre-examination phase of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for qualitative and/or (semi-)quantitative in situ examination of the morphology and of biomolecules, such as metabolites, proteins, DNA and/or RNA, on FFPE tissue sections by using different in situ detection techniques.
This document is applicable to in vitro diagnostic examinations using in situ detection techniques. These include laboratory developed tests performed by pathology laboratories (histopathology laboratories) as well as by molecular pathology laboratories and other medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, as well as institutions and commercial organizations performing biomedical research, and regulatory authorities.
This document is not applicable to the pre-examination phase of RNA, proteins and DNA isolated from FFPE tissue for examination. These are covered in ISO 20166-1, ISO 20166-2 and ISO 20166-3, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for isolated RNA, proteins and DNA, respectively.
Different dedicated measures are taken for pre-examination processes for fine needle aspirates (FNAs). These are covered in CEN WI 00140128, CEN WI 00140126, and CEN WI 00140129, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) isolated cellular RNA, isolated proteins, and isolated genomic DNA, respectively.
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 formalinfixierte und paraffineingebettete (FFPE-) Gewebeproben - Teil 4: In-situ-Detektionstechniken (ISO 20166-4:2021)
Dieses Dokument legt Anforderungen an die Entnahme, Handhabung, Dokumentation, den Transport sowie die Lagerung und Verarbeitung von formalinfixierten und paraffineingebetteten (FFPE )Gewebeproben während der präanalytischen Phase fest, die für die qualitative und/oder (semi )quantitative In situ-Untersuchung der Morphologie und von Biomolekülen, beispielsweise Metaboliten, Proteinen, DNA und/oder RNA, an FFPE Gewebeschnitten mittels verschiedener In situ-Nachweisverfahren vorgesehen sind, und enthält entsprechende Empfehlungen.
Dieses Dokument ist anzuwenden für In vitro-diagnostische Untersuchungen, bei denen In situ-Nachweisverfahren angewendet werden. Dazu zählen auch im Labor entwickelte Prüfverfahren, die von pathologischen Laboratorien (histopathologischen Laboratorien) sowie von molekularpathologischen Laboratorien und anderen medizinischen Laboratorien 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.
Dieses Dokument ist nicht anzuwenden für die präanalytische Phase der Untersuchung von RNA, Proteinen und DNA, die zu Untersuchungszwecken aus FFPE Gewebeproben isoliert wurden. Diese werden in ISO 20166 1, ISO 20166 2 und ISO 20166 3, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for isolated RNA, proteins and DNA behandelt.
Für die präanalytischen Prozesse von Feinnadelaspiraten (FNAs) sind andere zweckbestimmte Maßnahmen zu treffen. Diese werden in CEN WI 00140128, CEN WI 00140126 und CEN WI 00140129, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) isolated cellular RNA, isolated proteins, and isolated genomic DNA behandelt.
ANMERKUNG Für bestimmte Bereiche, die in diesem Dokument behandelt werden, können auch internationale, nationale oder regionale Bestimmungen oder Anforderungen gelten.
Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les tissus fixés au formol et inclus en paraffine (FFPE) - Partie 4: Techniques de détection in situ (ISO 20166-4:2021)
Le présent document spécifie des exigences et formule des recommandations concernant le prélèvement, la manipulation, la documentation, le transport, le stockage et le traitement durant la phase préanalytique de prélèvements de tissus fixés au formol et inclus en paraffine (FFPE) destinés à l’analyse in situ qualitative et/ou (semi‑)quantitative de la morphologie et de biomolécules, telles que des métabolites, des protéines, l’ADN et/ou l’ARN sur des coupes de tissu FFPE à l’aide de différentes techniques de détection in situ.
Le présent document s’applique aux analyses de diagnostic in vitro, utilisant des techniques de détection in situ. Celles‑ci englobent les analyses développées en laboratoire réalisées par des laboratoires de pathologie (laboratoires d’histopathologie) ainsi que par des laboratoires de pathologie moléculaire et autres laboratoires de biologie médicale. Il est également destiné à être utilisé par des clients de laboratoires, des développeurs et fabricants de l’industrie du diagnostic in vitro, des biobanques, ainsi que par des institutions et des organismes commerciaux spécialisés en recherche biomédicale, de même que des autorités de réglementation.
Le présent document ne s’applique pas à la phase préanalytique de l’analyse d’ARN, de protéines et d’ADN extraits de tissus FFPE, ces biomolécules étant respectivement couvertes par les normes ISO 20166‑1, ISO 20166‑2 et ISO 20166‑3, Analyses de diagnostic moléculaire in vitro — Spécifications relatives aux processus préanalytiques pour l’ARN extrait, les protéines extraites et l’ADN extrait.
Des mesures spéciales différentes sont prises pour les processus préanalytiques applicables aux prélèvements de biopsie à l’aiguille fine (BAF). Les mesures applicables aux différents prélèvements BAF (ARN cellulaire extrait, protéines extraites, et ADN génomique extrait) sont respectivement traitées par les CEN WI 00140128, CEN WI 00140126, et CEN WI 00140129, Molecular in vitro diagnostic examinations — Specifications for pre‑examination processes for Fine Needle Aspirates (FNAs) isolated cellular RNA, isolated proteins, and isolated genomic DNA (disponibles en anglais seulement).
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 tkiva, ki so fiksirana v formalinu ter položena v parafin - 4. del: Tehnike detekcije in situ (ISO 20166-4:2021)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 20166-4:2021
01-oktober-2021
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese za tkiva, ki so fiksirana v formalinu ter položena v parafin - 4. del: Tehnike
detekcije in situ (ISO 20166-4:2021)
Molecular in vitro diagnostic examinations - Specifications for preexamination processes
for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4: In situ detection
techniques (ISO 20166-4:2021)
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für formalinfixierte und paraffineingebettete (FFPE-)
Gewebeproben - Teil 4: In-situ-Detektionstechniken (ISO 20166-4:2021)
Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour les tissus fixés au formol et inclus en paraffine (FFPE) - Partie 4:
Techniques de détection in situ (ISO 20166-4:2021)
Ta slovenski standard je istoveten z: EN ISO 20166-4:2021
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
SIST EN ISO 20166-4:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 20166-4:2021
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SIST EN ISO 20166-4:2021
EN ISO 20166-4
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2021
EUROPÄISCHE NORM
ICS 11.100.10
English Version
Molecular in vitro diagnostic examinations - Specifications
for preexamination processes for formalin-fixed and
paraffin-embedded (FFPE) tissue - Part 4: In situ detection
techniques (ISO 20166-4:2021)
Analyses de diagnostic moléculaire in vitro - Molekularanalytische in-vitro-diagnostische Verfahren
Spécifications relatives aux processus préanalytiques - Spezifikationen für präanalytische Prozesse für
pour les tissus fixés au formol et inclus en paraffine formalinfixierte und paraffineingebettete (FFPE-)
(FFPE) - Partie 4: Techniques de détection in situ (ISO Gewebeproben - Teil 4: In-situ-Detektionstechniken
20166-4:2021) (ISO 20166-4:2021)
This European Standard was approved by CEN on 20 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,
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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 20166-4:2021 E
worldwide for CEN national Members.
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SIST EN ISO 20166-4:2021
EN ISO 20166-4:2021 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 20166-4:2021
EN ISO 20166-4:2021 (E)
European foreword
This document (EN ISO 20166-4:2021) 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 January 2022, and conflicting national standards shall
be withdrawn at the latest by July 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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websit
...
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