ISO 10993 - 18: An Introduction to Chemical Characterization of 医疗设备

在我们的信息网络研讨会中发现ISO 10993 - 18的复杂性. Decoding the complexities of medical device chemical characterization, our 可推断出的 & 可滤取的 (E&L)专家, 迈克·鲁上校 delves into standardized extraction methods and analytical techniques. Learn how studies are designed to effectively navigate regulatory landscapes, 确保产品合规性, 提高病人的安全.

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Unique challenges require complex ISO 10993 - 18 studies involving the use of multiple analytical techniques

随着医疗设备变得越来越复杂和多样化, 稳健实验研究设计的重要性, 考虑到设备类型, 使用方式, and material composition (including understanding the impact of biodegradable and recycled polymers) is clear-cut.

迈克强调了萃取研究的分析方法, 由测试伙伴开发并正确实现, must cover a wide range of chemical functionalities and impurity levels, 需要使用多种分析技术. 另外, 联合用药器械领域的进展, medical implants and improved consumer healthcare products all introduce new considerations and challenges in testing protocols. 

Industry experience and strong partnerships help to ensure evolving regulatory compliance

迈克 explains how an effective study requires a comprehensive understanding of regulatory requirements, 分析方法, 以及被评价医疗器械的具体特性. 另外, im体育平台app下载利益相关者之间的持续合作和沟通, 监管机构, and testing laboratories are all essential in driving progress toward compliance. Meeting the demands of different 监管机构 adds another layer of complexity due to the varying requirements.

观看本次网络研讨会的好处

• Gain comprehensive insights into ISO 10993 - 18 for effective medical device chemical characterization.
• Learn about study design, considering component nature and end-use scenarios.
• Enhance product development strategies by aligning with industry standards and scientific best practices.
• Stay ahead of evolving regulatory landscapes and technological advancements for accelerated device compliance.
• Empower decision-making with a deeper understanding of experimental design and risk assessment principles.
• Discover how standardized extraction methods and analytical techniques are implemented to ensure accurate assessments.
• Optimize safety evaluations with detailed toxicological assessments and threshold considerations.
• 更有信心地驾驭监管要求.

点击这里 观看我们的网络研讨会.

本次网络研讨会涵盖的主要主题

• Introduction to chemical characterization of medical devices according to ISO 10993 - 18.
• 理解E&L及其对产品安全的潜在影响.
• E .试验设计考虑因素的探讨&L研究.
• Overview of ISO 10993 - 18 guidelines and their application in medical device evaluation.
• Examination of standardized extraction conditions for diverse product usage scenarios.
• Analysis Assessment of different extraction techniques and 溶剂的选择 for comprehensive E&L评估.
• 使用分析方法，包括气相色谱-质谱, 质, 以及ICP-MS用于E&L.
• Incorporation of risk assessment strategies for setting analytical evaluation thresholds (AET).
• Considerations for future developments in medical device testing and regulatory compliance.

网络研讨会文摘

Discover the intricate world of ISO 10993 - 18 guidelines with this webinar. 探索医疗器械的化学特性, 从理解可提取到实验设计的细微差别. 揭示标准化提取条件的重要性, 溶剂的选择, and 分析方法 in supporting regulatory compliance and product safety.

Gain invaluable insights into risk assessment strategies to mitigate potential hazards and help ensure patient well-being. Join us on a journey to master the complexities of medical device evaluation, empowering you to navigate industry standards with confidence and precision.

摘自网络研讨会

"The main thing that we need to consider when we're considering how to design studies is the actual nature of the component that we're looking to extract."