Standard

SN-CEN/TS 17390-3:2020

Withdrawn
Preview

Corrigendums and amendments are bought separately.

Language
Services

Abstract

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood and the CTC (Circulating Tumor Cell) enrichment, CTC isolation and other preparations for analytical staining (i.e., conventional cytochemical and immunocytochemical staining) of CTCs during the pre-examination Phase before the cytopathological evaluation is performed.This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests 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.This document does not cover specific staining procedures.NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 2020-01
  • Version: 1
  • Document type: TS
  • ICS 11.100.10
  • National Committee SN/K 116

Product Relations

Product life cycle