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BS EN ISO 20184-2:2018:2019 Edition

BS EN ISO 20184-2:2018:2019 Edition

$142.49

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

Published By Publication Date Number of Pages
BSI 2019 26
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This document gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for the examination of isolated proteins during the pre-examination phase before a molecular assay is performed.

This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate proteins isolated from frozen tissue. 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.

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
12 4 General considerations
13 5 Outside the laboratory
5.1 Specimen collection
5.1.1 General
5.1.2 Information about the specimen donor/patient
14 5.1.3 Information about the specimen
5.1.4 Specimen processing
5.2 Fresh tissue transport requirements
5.2.1 General
15 5.2.2 Preparations for the transport
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)
16 6.3 Freezing of the specimen or sample(s)
18 6.4 Storage requirements
6.5 Isolation of total protein
6.5.1 General
19 6.5.2 Using commercial kits
6.5.3 Using the laboratories own protocols
6.6 Quantity and quality assessment of isolated proteins
20 6.7 Storage of isolated total protein
21 Annex A (informative) Quantitative protein examination demonstrates changes of protein amounts during cold ischemia
25 Bibliography

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BS EN ISO 20184-2:2018
$142.49