负压护创产品的设计与评价要点

      Point on Consideration of Products for Negative Pressure Wound Therapy Design and Evaluation

      • 摘要: 负压伤口治疗已经成为全球伤口护理领域的重要技术,该技术的发展离不开负压护创产品的开发和应用。结合负压护创产品的特点,从理化性能、生物学评价、适用范围和风险警示信息几个方面探讨了负压护创申报注册的设计和评价中应考虑的重点内容,供该类产品的研发及技术审评参考。

         

        Abstract: Negative pressure wound therapy has become an important technology in the global field of wound care, and the development of this technology is inseparable from the development and application of negative pressure wound care products. Based on the characteristics of the negative pressure wound therapy products, this paper discusses the key contents that should be considered in the design and evaluation of the negative pressure wound protection products from the aspects of physical and chemical properties, biocompatibility, intended use and risk warning information, in order to provide reference for the development and technical review of such products.

         

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