T/GDMDMA 0004-2022 Active

Scope: This document specifies the structure, materials, technical requirements, test methods, labels, instructions, packaging, transportation, and storage requirements for single-use sampling swabs (hereinafter referred to as "sampling swabs"). The single-use sampling swabs specified in this document are used for collecting samples from nasopharynx, oropharynx, mucous membranes, and wounds, etc. They can be combined with cups and tubes containing preservation solutions for transporting and storing samples, and are available in either sterile or non-sterile versions. Main technical contents: appearance, dimensions, odor, sampling head firmness, sampling head hair loss, sampling head water absorption, mechanical properties, microbiological indicators, biocompatibility, ethylene oxide residue, fluorescent substances, and primary packaging integrity.