Singapore legislation

Regulation 57

of Healthcare Services (Nuclear Medicine Service) Regulations 2023

Regulation 57

Standards for reagents

A licensee must ensure all of the following in relation to every reagent used in an applicable test:

(a)

regular evaluation of every reagent to ensure that it is capable of consistently producing accurate results in any applicable test in which it is intended to be used;

(b)

a reagent is not used in an applicable test after its date of expiry or beyond its shelf life, or if there is any other reason for any personnel to suspect that the reagent is no longer suitable to be used in an applicable test.