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ČSN EN ISO 4307 (857037)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
Translate name
STANDARD published on 1.6.2022
The information about the standard:
Designation standards: ČSN EN ISO 4307
Classification mark: 857037
Catalog number: 514498
Publication date standards: 1.6.2022
SKU: NS-1064200
The number of pages: 28
Approximate weight : 84 g (0.19 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 4307 (857037):
This document specifies requirements and recommendations on the handling, storage, processing and documentation of saliva specimens intended for human DNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories. It can also be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Dedicated measures that need to be taken for saliva collected on absorbing material or by mouth washes are not described in this document. Neither are measures for preserving and handling of native saliva cell-free DNA, pathogens, and other bacterial or whole microbiome DNA in saliva described. NOTE - International, national or regional regulations or requirements can also apply to specific topics covered in this document
Preview of the standard ČSN EN ISO 4307 (857037)
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