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BS EN ISO 20184-3:2021

BS EN ISO 20184-3:2021

$142.49

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue – Isolated DNA

Published By Publication Date Number of Pages
BSI 2021 24
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This document specifies requirements and gives recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA 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 evaluate DNA isolated from frozen tissue. 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.

Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.

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
13 4 General considerations
14 5 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
5.1.4 Specimen processing
15 5.2 Fresh tissue transport requirements
5.2.1 General
5.2.2 Preparations for the transport
16 5.2.3 During transport
6 Inside the laboratory
6.1 Information about the reception of the specimen
6.2 Evaluation of the pathology of the specimen and selection of the sample(s)
17 6.3 Freezing of the specimen or sample(s)
19 6.4 Storage requirements
6.5 DNA isolation
6.5.1 General
20 6.5.2 Using commercial kits
6.5.3 Using laboratory developed protocols
6.6 Quantity and quality assessment of isolated DNA
21 6.7 Storage of isolated DNA
22 Bibliography

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BS EN ISO 20184-3:2021
$142.49