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(接4月下)医用手套如有环氧乙烷残留量要求,还应符合GB/T 16886.7-2001《医疗器械生物学评价第7部分环氧乙烷灭菌残留量》中的相关要求;如有内毒素要求,还应符合YY/T 0616-2007《一次性使用医用手套生物学评价要求与试验》中的相关要求。为控制产品质量,企业在确定产品出厂检验项目时,需考虑关键质量控制点及相关标准要求。医用手套出厂检验项目至少应有以下项目:尺寸(长度、宽度、
(Next April) medical gloves, if any ethylene oxide residue requirements, but also in line with GB / T 16886.7-2001 “biological evaluation of medical devices Part 7 ethylene oxide sterilization residues” in the relevant requirements; If endotoxin requirements, but also in line with YY / T 0616-2007 “disposable medical gloves biological evaluation requirements and test” in the relevant requirements. In order to control the product quality, the enterprise must consider the key quality control points and related standards when determining the factory inspection items of the products. Medical gloves factory inspection items should have at least the following items: Size (length, width,