第一条 (立法目的) 为了加强对一次性使用无菌医疗器械的监督管理,预防医源性疾病,防止环境污染,保障人体健康和生命安全,根据《医疗器械监督管理条例》的规定,结合本市实际,制定本规定。 第二条 (含义) 本规定所称一次性使用无菌医疗器械(以下简称无菌器械),是指按照无菌器械进行产品注册,并在产品包装上标示“无菌”、“一次性使 Article 1 (Legislative Purpose) In order to strengthen supervision and administration of disposable sterile medical devices, prevent iatrogenic diseases, prevent environmental pollution and ensure human health and life safety, in accordance with the provisions of the “Regulations on the Supervision and Administration of Medical Devices” The actual city, the enactment of this provision. Article 2 (Meanings) The term “sterile medical devices” (hereinafter referred to as “sterile medical devices”) as mentioned in these Provisions refers to products registered according to sterile instruments and labeled “sterile”, "disposable