This standard specifies the terms and definitions, requirements, test methods, markings, labels, instructions for use, packaging, transportation and storage of DNA microarray chips for in vitro diagnostics. This standard applies to in vitro diagnostic-related DNA microarray chip products using planar substrates as carriers for qualitative detection.
YY/T 1153-2009 history
2009YY/T 1153-2009 DNA microarray for in vitro diagnostics