iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

CEN/TS 17390-3:2020

(Main)

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood and the CTC (Circulating Tumor Cell) enrichment, CTC isolation and other preparations for analytical staining (i.e., conventional cytochemical and immunocytochemical staining) of CTCs during the pre-examination Phase before the cytopathological evaluation is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. 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.
This document does not cover specific staining procedures.
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 zirkulierende Tumorzellen (CTC) in venösen Vollblutproben - Teil 3: Vorbereitungen für die analytische CTC Färbung

Dieses Dokument spezifiziert Empfehlungen zur Handhabung, Lagerung, Verarbeitung und Dokumentation von Proben venösen Vollbluts, die für die Färbung der zirkulierenden Tumorzellen (CTCs) vorgesehen sind, während der präanalytischen Phase vor der Durchführung einer molekularen Analyse.
Dieses Dokument ist anwendbar auf molekulare in vitro diagnostische Untersuchungen, die in medizinischen Laboratorien durchgeführt werden, einschließlich vom Laboratorium selbst entwickelter Verfahren. Es ist darüber hinaus für die Verwendung durch Kunden von Laboratorien, Entwickler und Hersteller von In vitro Diagnostika, durch Biobanken, Institutionen und kommerzielle Organisationen, die biomedizinische Forschungen durchführen, sowie durch Arzneimittelagenturen bestimmt.
Dieses Dokument behandelt nicht die Anforderungen an den präanalytischen Arbeitsablauf zur Kryokonser¬vierung und Kultivierung lebensfähiger CTCs.
ANMERKUNG 1 Die in diesem Dokument dargelegten Anforderungen können auch auf andere zirkulierende Zellen (z. B. fetale Zellen) angewendet werden.
ANMERKUNG 2 Internationale, nationale oder regionale Regelungen bzw. Anforderungen können ebenfalls für bestimmte Themen in diesem Dokument gelten.

Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les cellules tumorales circulantes (CTC) du sang total veineux - Partie 3 : Préparations pour l’analyse par coloration des CTC

Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese za cirkulirajoče tumorske celice (CTC) v venski polni krvi - 3. del: Priprave za analitično barvanje CTC

General Information

Status
Published
Publication Date
21-Jan-2020
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-Jan-2020
Due Date
28-Jan-2020
Completion Date
22-Jan-2020
Ref Project
SIST-TS CEN/TS 17390-3:2020 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining

Buy Standard

TS CEN/TS 17390-3:2020TS CEN/TS 17390-3:2020
PreviousNext
Technical specification
TS CEN/TS 17390-3:2020
English language
19 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN/TS 17390-3:2020
01-marec-2020
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese za cirkulirajoče tumorske celice (CTC) v venski polni krvi - 3. del: Priprave
za analitično barvanje CTC
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for circulating tumor cells (CTCs) in venous whole blood - Part 3: Preparations for
analytical CTC staining
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für zirkulierende Tumorzellen (CTC) in venösen Vollblutproben
- Teil 3: Vorbereitungen für die analytische CTC-Färbung
Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour les cellules tumorales circulantes (CTC) du sang total veineux -
Partie 3 : Préparations pour l’analyse par coloration des CTC
Ta slovenski standard je istoveten z: CEN/TS 17390-3:2020
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
SIST-TS CEN/TS 17390-3:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST-TS CEN/TS 17390-3:2020

---------------------- Page: 2 ----------------------
SIST-TS CEN/TS 17390-3:2020


CEN/TS 17390-3
TECHNICAL SPECIFICATION

SPÉCIFICATION TECHNIQUE

January 2020
TECHNISCHE SPEZIFIKATION
ICS 11.100.10
English Version

Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for circulating tumor cells
(CTCs) in venous whole blood - Part 3: Preparations for
analytical CTC staining
Analyses de diagnostic moléculaire in vitro - Molekularanalytische in-vitro-diagnostische Verfahren
Spécifications relatives aux processus préanalytiques - Spezifikationen für präanalytische Prozesse für
pour les cellules tumorales circulantes (CTC) du sang zirkulierende Tumorzellen (CTC) in venösen
total veineux - Partie 3 : Préparations pour l'analyse Vollblutproben - Teil 3: Vorbereitungen für die
par coloration des CTC analytische CTC-Färbung
This Technical Specification (CEN/TS) was approved by CEN on 27 October 2019 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 17390-3:2020 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST-TS CEN/TS 17390-3:2020
CEN/TS 17390-3:2020 (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 .
...

Questions, Comments and Discussion

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

This May Also Interest You

CEN
EN ISO 20916:2024(Main)
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
SIST EN ISO 20916:2024

This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes.
NOTE 1    The purpose of these studies is to assess the ability of an IVD medical device in the hands of the intended user, to yield results pertaining to a particular medical condition or physiological/pathological state, in the intended population.
The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study.
This document identifies the principles that underpin clinical performance studies and specifies general requirements intended to
—          ensure the conduct of the clinical performance study will lead to reliable and robust study results,
—          define the responsibilities of the sponsor and principal investigator,
—          assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices, and
—          protect the rights, safety, dignity and well-being of the subjects providing specimens for use in clinical performance studies.
Analytical performance studies are out of the scope of this document.
NOTE 2    When the collection of specimens specifically for the analytical performance study creates an additional collection risk for subjects, some of the elements of this document (particularly the annexes) can be useful for ensuring subject safety.
Clinical performance studies that are performed for reasons other than pre- and post-market regulatory purposes, such as for re-imbursement purposes, are out of the scope of this document.
NOTE 3    Some of the elements of this document can be useful for the design of such studies, including subject safety and data integrity.
This document does not include safety information for laboratory workers or other personnel collecting the study specimens.
NOTE 4    Such information is included in other publications[1][12][13].
NOTE 5    Users of this document can consider whether other standards and/or requirements also apply to the IVD medical device which is the subject of the clinical performance study, for instance, in the situation for which there is an IVD medical device and a medical device used in an integrated system (e.g. a lancet, an IVD test strip, and a glucose meter), aspects of both this document and ISO 14155 can be considered.

  • Draft
    72 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN/TS 17981-2:2023(Main)
In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 2: Human RNA examination
SIST-TS CEN/TS 17981-2:2024

This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows for in vitro diagnostics and biomedical research. This document covers the pre-examination processes, human RNA isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated RNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, and circulating cell free RNA from plasma.
NOTE 1   Typical applications include, but are not limited to, NGS for oncology and clinical genetics, certain single-cell analyses.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories, molecular pathology laboratories and molecular genetic laboratories. This document is also applicable to laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions, and organisations performing biomedical research.
This document is not applicable for in situ sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis.
NOTE 2   International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.

  • Technical specification
    64 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN/TS 17981-1:2023(Main)
In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 1: Human DNA examination
SIST-TS CEN/TS 17981-1:2024

This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows for in vitro diagnostics and biomedical research. This document covers the pre-examination processes, human DNA (somatic and germline) isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated DNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, circulating cell free DNA from plasma, and DNA from saliva.
NOTE 1   Typical applications include, but are not limited to, NGS for oncology, pharmacogenomics and clinical genetics; approaches include panels (e.g. disease panels, exome panels, target gene panels and in silico panels), exome and whole genome sequencing, as well as certain epigenetics and certain single-cell analyses.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories, molecular pathology laboratories and molecular genetic laboratories. This document is also applicable to laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions, and organizations performing biomedical research.
This document is not applicable for in situ sequencing, DNA-mediated protein sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis.
NOTE 2   International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.

  • Technical specification
    60 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN/TS 17811:2022(Main)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA
SIST-TS CEN/TS 17811:2022

This document specifies requirements and gives recommendations on the handling, storage, processing and documentation of body fluids specimens intended for human cfDNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health institutions including facilities collecting and handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Dedicated measures that need to be taken for cytohistological analysis of body fluid derived nucleated cells are not described in this technical specification. Neither are measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described.
Different dedicated measures need to be taken for preserving ccfDNA from other body fluids such as blood, lymph and others. These are not described in this document. ccfDNA from blood is covered in EN ISO 20186-3.
NOTE   International, national or regional regulations or requirements can also apply to specific topics covered in this document.

  • Technical specification
    24 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN/TS 17747:2022(Main)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins
SIST-TS CEN/TS 17747:2022

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for DNA, RNA and protein examination from exosomes and other extracellular vesicles during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes.
The pre-examination process described in this document results in isolated DNA, RNA and proteins from enriched exosomes and other extracellular vesicles.
This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health care institutions including facilities collecting and handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken during the pre-examination phase for venous whole blood circulating cell-free RNA (ccfRNA) examination and for venous whole blood circulating cell-free DNA (ccfDNA) examination, both without prior enrichment of exosomes and other extracellular vesicles. These are not described in this document but are covered in EN ISO 20186 3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma and CEN/TS 17742, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma.
NOTE   International, national or regional regulations or requirements can also apply to specific topics covered in this document.

  • Technical specification
    30 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN/TS 17742:2022(Main)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma
SIST-TS CEN/TS 17742:2022

This document specifies requirements and recommendations for the pre-examination phase of circulating cell free RNA (ccfRNA) from venous whole blood specimens, including but not limited to the collection, handling, storage, processing and documentation of venous whole blood specimens intended for ccfRNA examination. This document covers specimens collected in venous whole blood collection tubes.
The pre-examination process described in this document results in circulating cell free RNA isolated from blood plasma without prior enrichment of exosomes and other extracellular vesicles.
This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. 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.
Different dedicated measures need to be taken during the pre-examination phase for isolated RNA from enriched exosomes and other extracellular vesicles enriched from venous whole blood and for cellular RNA isolated from venous whole blood. These are not described in this document but are covered in CEN/TS 17747,  Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - Isolated DNA, RNA and proteins, and in EN ISO 20186 1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA.
NOTE   International, national or regional regulations or requirements can also apply to specific topics covered in this document.

  • Technical specification
    25 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN/TS 17688-2:2021(Main)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 2: Isolated proteins
SIST-TS CEN/TS 17688-2:2022

This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs) intended for protein 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 proteins 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 20184-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins and EN ISO 20166-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins.
This document is not applicable for protein examination by immunohistochemistry.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

  • Technical specification
    26 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
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
SIST-TS CEN/TS 17688-3:2022

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.

  • Technical specification
    36 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN/TS 17688-1:2021(Main)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA
SIST-TS CEN/TS 17688-1:2022

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.

  • Technical specification
    38 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 4307:2021(Main)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
SIST EN ISO 4307:2022

This document specifies requirements and recommendations on the handling, storage, processing and documentation of saliva specimens intended for human 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. It can also be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Dedicated measures that need to be taken for saliva collected on absorbing material or by mouth washes are not described in this document. Neither are measures for preserving and handling of native saliva cell-free DNA, pathogens, and other bacterial or whole microbiome DNA in saliva described.
NOTE       International, national or regional regulations or requirements can also apply to specific topics covered in this document.

  • Standard
    21 pages
    English language
    sale 10% off
    e-Library read for
    1 day