Measuring interval (range)

For an IVD, the measuring interval is a labeled performance claim. Results outside it are not reliable without further handling, and linearity and quantitation limit studies support the claimed interval.

A set of values of quantities of the same kind that can be measured by a given measuring instrument or measuring system with specified instrumental measurement uncertainty, under defined conditions

MDCG 2022-2, Section 4, Definitions (source: VIM 3rd edition)