Introduction to ISO 10993 : Medical Device Biocompatibility скачать в хорошем качестве

Introduction to ISO 10993 : Medical Device Biocompatibility

ISO 10993 is a comprehensive standard for the biological evaluation of medical devices, providing a framework to assess their safety and biocompatibility. It guides manufacturers in identifying potential biological risks associated with materials used in medical devices and ensuring their compatibility with the human body. The standard outlines a series of tests, including cytotoxicity, sensitization, genotoxicity, and implant compatibility, to evaluate the effects of medical devices on biological systems. By following ISO 10993, organizations can ensure regulatory compliance, reduce risks to patients, and maintain high safety standards throughout a device's lifecycle, from design and development to manufacturing and market approval. email- [email protected] website- https://tnvakademi.com/ #iso #audit #tnvakademi #certification #iso10993 #medical #device #biocompatibility #biological #evaluation #medicaldevice Timecodes 0:00 - Introduction 0:38 - Why Is Biocompatibility Important? 1:10 - Scope of ISO 10993 1:51 - How Is Testing Conducted? 2:20 - Regulatory Compliance 2:43 - Conclusion