ISO/AWI 26298

Test kits and portable equipment for field drug testing — Requirements for quality and operation

Апстракт

This document specifies requirements for the manufacture and on‑site utilization of test kits and portable electronic devices used for the collection, detection and reporting of controlled substances in the field. It covers:
a) manufacturing requirements for product design, production and quality control;
b) on‑site use requirements for operation, interpretation of results and safety management;
c) records and reporting requirements; and
d) information to be supplied by manufacturers to enable effective on‑site use.
This document focuses on equipment used for presumptive screening in field settings, including reagent‑based kits, swab‑based devices and portable spectrometers. This document does not include specific test protocols for laboratory confirmation, regulatory classification of substances, or clinical diagnostic use.