Abstract: OBJECTIVE To establish a sterility test method for external liquid medical high-density polyethylene bottle(for extensive burns and severe skin damage), and check the suitability of the method. METHODS The sterilized saline was used as a eluent. According to the sampling amount of medical devices in general rule 1101 of Chinese Pharmacopoeia 2015 Edition, 1/2 labeled volume of sodium chloride injection was added, and the sample was shaken for 30 s. The extracts were combined and examined by membrane filtration. RESULTS The eluting recovery rates of Staphylococcus aureus, Escherichia coli, Bacillus subtilis, Candida albicans and Aspergillus niger in the study of pretreatment for sterility test were in line with the requirements of Chinese Pharmacopoeia. The growth of the tested bacteria was good in the method suitability test. CONCLUSION This method is scientific and effective in sample quantity and sample pretreatment. It is suitable for sterility test of external liquid medical high-density polyethylene bottle(for large area burn and severe skin injury).