医疗器械中双酚A的应用及安全评价

      Application and Safety Evaluation of Bisphenol A in Medical Instruments

      • 摘要: 双酚A广泛应用于医疗器械的制造,与人体有直接或间接的接触,通过消化道、呼吸道、血液等途径进入人体。目前,国内外对于双酚A的监管主要集中于食品包装及婴幼儿用品,对于医疗器械中双酚A的使用未做明确限定。在医疗器械中对双酚A的应用安全性评价还很缺乏,对潜在的危险因素监管存在漏洞。医疗器械在使用时释放的双酚A可能会对人体的健康带来潜在的危害,有必要对医疗器械中双酚A的安全性进行评估。

         

        Abstract: Bisphenol A (BPA) is widely used in the production of medical instruments, and has direct or indirect contacts with the human body through the digestive tract, respiratory tract, blood and other ways to enter the body. At present, the main regulatory for bisphenol A is focus on the food packaging and products for babies. There is no clear limits made for the use of bisphenol A in medical instruments. Government lacks the safety evaluation for the application of bisphenol A in the medical instruments. There are imperfections in the regulation and supervision of the potential risks in the application of bisphenol A. The release of bisphenol A when using medical instruments could lead to potential harmful impact on human's health, it is necessary to evaluate the safety of bisphenol A in medical instruments.

         

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