Reference number
ISO 20166-2:2018
International Standard
ISO 20166-2:2018
Molecular in vitro diagnostic examinations — Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins
Edition 1
2018-12
Preview
ISO 20166-2:2018
69802
недоступно на русском языке
Опубликовано (Версия 1, 2018)

ISO 20166-2:2018

ISO 20166-2:2018
69802
Язык
Формат
CHF 129
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Тезис

This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for the examination of isolated proteins during the pre-examination phase before a molecular assay is performed.

This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology 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.

This document is not applicable for protein examination by immunohistochemistry.

NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Общая информация

  •  : Опубликовано
     : 2018-12
    : Рассылка краткого отчета о пересмотре [90.60]
  •  : 1
  • ISO/TC 212
    11.100.10 
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