This standard specifies the general product classification, requirements, test methods and signs, labels, instructions for use, packaging, transportation and storage of immunohistochemistry kits. This standard applies to tissue/cytochemistry qualitative kits used in medical laboratories for the detection of paraffin sections, frozen sections, smears, slides and other specimens based on antigen-antibody reactions. The kits include at least primary antibodies and color development system.
YY/T 1181-2010 Referenced Document
GB/T 191 Packaging.Pictorial marking for handling of goods
YY/T 0466.1-2009 Medical devices.Symbols to be used with medical device labels,labelling and information to be supplied.Part 1:General requirements