1. Scope 1.1 This Standard applies to reagent kits which employ a radioimmunoassay for
the measurement of total triiodithyronine [T3 (RIA)] in human blood. 1.2 This Standard defines minimum requirements for the performance, labelling,
testing and evaluation of such reagent kits. Note: Labellling requirements are intended to supplement the general provisions
of Medical Devices Regulations made pursuant to the Food and Drugs Act, RSC
1970, cF-27.