Cookies
We need your consent to use the individual data so that you can see information about your interests, among other things. Click "OK" to give your consent.
ČSN EN ISO 20166-4 (857032)
Molecular in vitro diagnostic examinations - Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4: In situ detection techniques
Translate name
STANDARD published on 1.3.2022
The information about the standard:
Designation standards: ČSN EN ISO 20166-4
Classification mark: 857032
Catalog number: 513750
Publication date standards: 1.3.2022
SKU: NS-1050144
The number of pages: 40
Approximate weight : 120 g (0.26 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 20166-4 (857032):
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
Preview of the standard ČSN EN ISO 20166-4 (857032)
We recommend:
Technical standards updating
Do you want to make sure you use only the valid technical standards?
We can offer you a solution which will provide you a monthly overview concerning the updating of standards which you use.
Would you like to know more? Look at this page.
