ISO/DIS 18704

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Проект данного международного стандарта находится на этапе рассмотрения членами ИСО.

ISO/DIS 18704

CHF 63

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Тезис

This document specifies requirements and provides recommendations for the pre-examination phase of cell free DNA (cfDNA) from body fluid specimens other than blood, including but not limited to the collection, handling, storage, transport, processing and documentation of human body fluids, such as urine, cerebrospinal fluid (CSF), pleural effusions and saliva, intended for cfDNA examination. Processing includes multiple steps, such as centrifugation for specimen cleaning and isolation of cfDNA. This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health institutions including facilities collecting and handling specimen, 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 cytohistological analysis of body fluid derived nucleated cells are not described in this document. Neither are measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described. Different dedicated measures need to be taken for preserving circulating cell free DNA (ccfDNA) from blood. These are not described in this document, but are covered in ISO 20186-3. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Общая информация

Текущий статус
: В стадии разработки

You can help develop this draft international standard by contacting your national member

Этап
: Начало голосования по проекту между-народно-го стандарта: 3 мес. [40.20]
Версия
: 1
Технический комитет :
ISO/TC 212

ICS :
11.100.10
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