SIST-TS CEN ISO/TS 7552-3:2025

SLOVENSKI STANDARD
01-januar-2025
Nadomešča:
SIST-TS CEN/TS 17390-3:2020
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 (ISO/TS 7552-3:2024)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for circulating tumour cells (CTCs) in venous whole blood - Part 3: Preparations for
analytical CTC staining (ISO/TS 7552-3:2024)
Spezifikationen für präanalytische Prozesse für zirkulierende Tumorzellen (CTC) in
venösen Vollblutproben - Teil 3: Vorbereitungen für die analytische CTC-Färbung
(ISO/TS 7552-3:2024)
Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour les cellules tumorales circulantes (CTC) dans le sang total veineux -
Partie 3: Préparations pour l’analyse par coloration des CTC (ISO/TS 7552-3:2024)
Ta slovenski standard je istoveten z: CEN ISO/TS 7552-3:2024
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

CEN ISO/TS 7552-3
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
November 2024
TECHNISCHE SPEZIFIKATION
ICS 11.100.10 Supersedes CEN/TS 17390-3:2020
English Version
Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for circulating tumour cells
(CTCs) in venous whole blood - Part 3: Preparations for
analytical CTC staining (ISO/TS 7552-3:2024)
Analyses de diagnostic moléculaire in vitro - Spezifikationen für präanalytische Prozesse für
Spécifications relatives aux processus préanalytiques zirkulierende Tumorzellen (CTC) in venösen
pour les cellules tumorales circulantes (CTC) dans le Vollblutproben - Teil 3: Vorbereitungen für die
sang total veineux - Partie 3: Préparations pour analytische CTC-Färbung (ISO/TS 7552-3:2024)
l'analyse par coloration des CTC (ISO/TS 7552-3:2024)
This Technical Specification (CEN/TS) was approved by CEN on 10 November 2024 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, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 7552-3:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (CEN ISO/TS 7552-3:2024) has been prepared by Technical Committee ISO/TC 212
"Medical laboratories and in vitro diagnostic systems" in collaboration with Technical Committee
CEN/TC 140 “In vitro diagnostic medical devices” the secretariat of which is held by DIN.
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 17390-3:2020.
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 website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to announce this Technical Specification: 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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO/TS 7552-3:2024 has been approved by CEN as CEN ISO/TS 7552-3:2024 without any
modification.
Technical
Specification
ISO/TS 7552-3
First edition
Molecular in vitro diagnostic
2024-11
examinations — Specifications
for pre-examination processes for
circulating tumour cells (CTCs) in
venous whole blood —
Part 3:
Preparations for analytical CTC
staining
Analyses de diagnostic moléculaire in vitro — Spécifications
relatives aux processus préanalytiques pour les cellules tumorales
circulantes (CTC) dans le sang total veineux —
Partie 3: Préparations pour l’analyse par coloration des CTC
Reference number
ISO/TS 7552-3:2024(en) © ISO 2024

ISO/TS 7552-3:2024(en)
© ISO 2024
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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO/TS 7552-3:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3  Terms and definitions . 1
4 General considerations . 5
5 Activities outside the laboratory. 6
5.1 Specimen collection .6
5.1.1 General .6
5.1.2 Information about the specimen donor/patient.6
5.1.3 Selection of the venous whole blood collection tube by the laboratory .6
5.1.4 Venous whole blood specimen collection from the patient/donor .7
5.2 Specimen storage and transport .7
5.2.1 General .7
5.2.2 Storage and transport using blood collection tubes with stabilizers .8
5.2.3 Storage and transport using blood collection tubes without stabilizers .8
6 Activities inside the laboratory . 8
6.1 Specimen reception .8
6.2 Specimen storage after transport and reception .9
6.3 Enrichment of CTCs .9
6.3.1 General .9
6.3.2 Using a commercial CTC enrichment system intended for diagnostic use .9
6.3.3 Using the laboratory developed CTC enrichment procedure .10
6.4 Quality of enriched CTCs .10
6.5 Storage of enriched CTCs .10
6.6 Preparation for CTC staining .10
6.6.1 General .10
6.6.2 Pretreatment for different staining techniques (antibody, colour staining, in
situ techniques) .11
Annex A (informative)  Decision guideline for critical steps of the CTC pre-analytical workflow .12
Bibliography . 14

iii
ISO/TS 7552-3:2024(en)
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 committee
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with the International Electrotechnical Commission (IEC) on all matters of 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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constitute an endorsement.
For an exp
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