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为确保国产改性聚乙烯宫内节育器的临床使用安全,遂对该产品进行了急性毒性、遗传毒性、亚慢性毒性、致畸作用等实验研究。结果显示,在本实验余件下,对受试动物不产生明显急慢性毒性反应,亦未见诱发致畸、致突变作用。提示该宫内节育器是安全的。
In order to ensure the safety of domestic use of modified polyethylene IUD, the experimental study on acute toxicity, genotoxicity, subchronic toxicity and teratogenicity of the product was conducted. The results showed that in the remaining part of the experiment, the animals did not produce significant acute and chronic toxicity, but also did not induce teratogenic and mutagenic effects. Tips IUD is safe.