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BS EN ISO 20166-4:2021

BS EN ISO 20166-4:2021

$167.15

Molecular in vitro diagnostic examinations. Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue – In situ detection techniques

Published By Publication Date Number of Pages
BSI 2021 36
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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.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
16 4 General considerations
18 5 Activities outside the laboratory
5.1 Specimen collection
5.1.1 General
5.1.2 Information about the patient/specimen donor
5.1.3 Information about the specimen
19 5.1.4 Specimen processing, intermediate storage and preparation for transport
20 5.2 Transport
6 Activities inside the laboratory
6.1 Specimen reception
6.2 Formalin fixation of the specimen or sample(s)
21 6.3 Evaluation of the pathology of the specimen and selection of the sample(s)
6.3.1 General
22 6.3.2 Macroscopic evaluation
6.3.3 Selection of the sample(s)
23 6.4 Post-fixation of frozen samples from intraoperative consultation
6.5 Sample decalcification/softening
24 6.6 Tissue processing and paraffin embedding
6.6.1 General
6.6.2 Dehydration and clearing
25 6.6.3 Impregnation with paraffin and paraffin embedding
6.7 Storage of FFPE tissue blocks
26 6.8 Sectioning of FFPE tissue blocks and storage of slide-mounted sections
27 6.9 Deparaffinization and rehydration of slide-mounted sections
6.10 Pretreatment of slide-mounted sections for in situ detection techniques
6.10.1 General
6.10.2 Pretreatment for antibody- or other affinity binder-based in situ detection techniques
28 6.10.3 Pretreatment for hybridization-based in situ detection techniques
6.10.4 Pretreatment for other in situ detection techniques
6.11 Quality assessment of the pre-analytical part of in situ detection
29 Annex A (informative) Recommendations relating to verification and validation of laboratory developed in situ detection tests
30 Annex B (informative) Example protocol for tissue processing
31 Bibliography

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BS EN ISO 20166-4:2021
$167.15