Satisfying ISO 18562 and FDA Biocompatibility Requirements for Breathing Gas Pathways Devices
In March of 2017, the new ISO 18562 standard series was released. This standard covers the general principles regarding biocompatibility assessment of medical device materials which comprise the gas pathway. This standard greatly increases the scrutiny for gas path devices and their required tests. This presentation will cover the required biological endpoints and the unique test methods to test these devices.
Видео Satisfying ISO 18562 and FDA Biocompatibility Requirements for Breathing Gas Pathways Devices канала Nelson Labs
Видео Satisfying ISO 18562 and FDA Biocompatibility Requirements for Breathing Gas Pathways Devices канала Nelson Labs
Показать
Комментарии отсутствуют
Информация о видео
Другие видео канала
Single-Use Endoscopes: Critical Safety and Regulatory Considerations for ManufacturersPackage Validations – Meeting the Requirements of ISO 11607The Impacts of Updated Standards on IFU Validations for Reusable Medical DeviceWhat Makes a Successful ISO 18562 Toxicological Risk Assessment?NVR Reconciliation – Expectations versus RealityDeveloping Contamination Control StrategyImpact of Device Changes on BiocompatibilityBioburden testing & organism characterization: Enhanced guidance for low-sterilization dose productsPreparing a Device Master Record (DMR)Controlling Endotoxins Contamination during Pharmaceutical ProductionFrequently Asked Questions about Combination ProductsSwitching Sterilization: What Should You Consider When Changing ProcessesRemoving rabbits from irritation testing: Regulatory acceptance of ISO 10993-23Sterilization and Sterility Verification of Single Use SystemsSkin-Care Products: Understanding Clinical Testing OptionsIs it time to re-evaluate your Design History File (DHF)?The Biocompatibility Trail: A challenging hike towards animal free testingBiocompatibility/Biosafety: Evaluating the Impact of a ChangeAppropriate uses for Product Sterility Testing – when is sterility testing appropriateEPA Regulatory Guidelines and Testing for Residual Efficacy ProductsCleaning Validation Roadmap for Reusable Medical Devices