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Two basic types of preparation are used to visualize specimens with a light microscope: wet mounts and fixed specimens.
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News from the Biological Stain Commission, no. 16.

H O Lyon1

  • 1Department of Pathology 134, Hvidovre Hospital. University of Copenhagen , Kettegard Allé 30, DK-2650 Hvidovre , Denmark.

Biotechnic & Histochemistry : Official Publication of the Biological Stain Commission
|March 10, 2015
PubMed
Summary

The Biological Stain Commission (BSC) International Affairs Committee shared updates on regulatory affairs from key international meetings in 2013. Key discussions involved in vitro diagnostic medical devices and clinical laboratory testing standards.

Keywords:
CEN/TC 140ISO/TC 212International Standards Organizationclinical laboratory testingin vitro diagnostic medical devicesin vitro diagnostic productsin vitro diagnostic test systems

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Area of Science:

  • Regulatory Affairs
  • International Standards
  • Biological Stains

Background:

  • The Biological Stain Commission (BSC) International Affairs Committee convened to discuss global regulatory landscapes.
  • Updates were provided from significant international standardization meetings impacting the diagnostics and laboratory testing sectors.

Framework:

  • The 28th meeting of CEN/TC 140 (In vitro diagnostic medical devices) in Berlin.
  • The 19th meeting of ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic test systems) in Singapore.

Implementation:

  • Focus on regulatory affairs concerning in vitro diagnostic medical devices.
  • Discussion of standards for clinical laboratory testing and in vitro diagnostic test systems.

Implications:

  • Harmonization of international standards for diagnostic devices and laboratory testing.
  • Ensuring quality and safety in the global supply of biological stains and diagnostic products.