PD CEN/TS 16826-1:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue Isolated RNA
Hardcopy , PDF
05-01-2019
English
31-08-2015
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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.
| Committee |
CH/212
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
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.
| 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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