Since the potential side effects of phthalate plasticisers on the human body have aroused widespread concern,medical device regulatory bodies in various countries have begun to advocate the use of alternatives.In June 2024,the European Union published updated guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices.This paper summarizes the leaching and extractable properties,exposure pathways and research progress of alternative plasticisers in the guidelines,hoping to contribute to improving their safety evaluation.
medical devicesDEHPalternative plasticiserssafety evaluationhuman exposure
维普
万方数据
