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ČSN P CEN/TS 17626 (857040)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA
Translate name
STANDARD published on 1.11.2021
The information about the standard:
Designation standards: ČSN P CEN/TS 17626
Classification mark: 857040
Catalog number: 512995
Publication date standards: 1.11.2021
SKU: NS-1041240
The number of pages: 44
Approximate weight : 132 g (0.29 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN P CEN/TS 17626 (857040):
This document specifies requirements and gives recommendations for the pre-examination phase of human specimens, such as stool, saliva, skin and urogenital specimens, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, transport, storage, processing, isolation of DNA, and documentation. This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. 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. Different dedicated measures are taken for pre-examination processes for infectious disease examination (e.g. targeted pathogen identification) and for microbiome DNA examination from tissue (e.g. biopsies). These are outside of the scope of this document. Different dedicated measures are taken for pre-examination processes for saliva for human genomic DNA examination. These are not described in this document but are covered in CEN/TS 17305, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated DNA. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document
Preview of the standard ČSN P CEN/TS 17626 (857040)
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