This Technical Specification provides requirements and guidance for selecting and assessing the quality of reagents to be used for in vitro diagnostic staining in biology.

This Technical Specification applies to the professional use of reagents for staining in biology by medical laboratories, and in particular, to those who are responsible for the requisition and evaluation of these reagents in medical laboratory disciplines such as clinical cytology, haematology, histopathology, microbiology, and molecular biology.