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PD CEN/TS 16826-1:2015

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue Isolated RNA
Available format(s)

Hardcopy , PDF

Superseded date

05-01-2019

Language(s)

English

Published date

31-08-2015

Publisher

British Standards Institution

European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Outside the laboratory
6 Inside the laboratory
Annex A (informative) - Impact of preanalytical variables
        on RNA profiles obtained from frozen
        liver tissue samples collected during and after
        routine surgery
Bibliography

Recommends the handling, documentation and processing of frozen tissue specimens intended for RNA analysis during the pre-analytical phase before a molecular assay is performed.

This Technical Specification recommends the handling, documentation and processing of frozen tissue specimens intended for RNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g., in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organisations performing biomedical research, biobanks, and regulatory authorities). RNA profiles in tissues can change significantly before and after collection and can change differently in different donors’ / patients’ tissues. Therefore, special measures have to be taken to minimize the described profile changes and modifications within the tissue for subsequent RNA analysis. Tissues that have undergone chemical stabilisation pre-treatment before freezing are not covered in this document.

Committee
CH/212
DocumentType
Standard
Pages
20
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

Standards Relationship
CEN/TS 16826-1:2015 Identical

ISO 22174:2005 Microbiology of food and animal feeding stuffs Polymerase chain reaction (PCR) for the detection of food-borne pathogens General requirements and definitions
ISO 15189:2012 Medical laboratories — Requirements for quality and competence
EN ISO 22174:2005 Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the detection of food-borne pathogens - General requirements and definitions (ISO 22174:2005)
ISO 15190:2003 Medical laboratories Requirements for safety
ISO Guide 30:2015 Reference materials Selected terms and definitions

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PDF - English
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