This standard specifies the terms and definitions, requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of influenza A (H1N1) virus RNA detection kits. This standard applies to diagnostic kits based on the principle of fluorescence PCR for the qualitative detection of influenza A (H1N1) virus RNA in human nose, throat swabs or other respiratory secretion samples.
YY/T 1462-2016 Referenced Document
GB/T 191 Packaging.Pictorial marking for handling of goods
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*, 2023-09-05 Update