医用创面敷料质量评价研究策略

      Research Strategies for Quality Evaluation of Medical Wound Dressings

      • 摘要: 由于医用创面敷料种类繁多、质量参差不齐,目前尚无统一国家/行业标准加以规范,基于此,该文提出医用创面敷料质量评价体系研究策略。通过构建技术路径图,明确各步骤流程及质量评价过程中的关键点,建立各种类型医用创面敷料的评价方法,梳理医用创面敷料质量评价体系研究中,如何基于产品特性确定关键性能指标、如何对关键项目试验方法进行研究和验证等重要问题,给广大医用创面敷料生产企业、检测机构、监管部门等提供一套详细、可行的研究策略和评价方法,降低医用创面敷料产品质量评价的难度及成本,对规范和提高医用创面敷料的质量水平、保障医用创面敷料产品的安全性和有效性、服务医疗器械质量安全监管具有重要意义。

         

        Abstract: Due to the wide variety and varying quality of medical wound dressings, as well as the current lack of unified national or industry standards for regulation, so ‌this paper proposes a research strategy for establishing a quality evaluation system for medical wound dressings‌. By developing a technical roadmap, this strategy clarifies the process flow and key points in the quality evaluation process, establishes evaluation methods for various types of medical wound dressings, and addresses important issues such as how to determine key performance indicators based on product characteristics and how to research and validate test methods for key items. This provides a detailed and feasible research strategy and evaluation method for medical wound dressing manufacturers, testing institutions, and regulatory authorities. It reduces the difficulty and cost of quality evaluation for medical wound dressings and has great significance in standardizing and improving the quality level of medical wound dressings, ensuring their safety and effectiveness, and serving the quality and safety regulation of medical devices.‌

         

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