Biocompatibility testing of Medical Devices.
From diagnostics through surgery, medical professionals use a variety of devices to address patient health. When medical equipment or material comes into contact with a patient, it should perform its intended purpose without harming the patient. As a result, all medical devices must undergo a rigorous biological risk assessment to safeguard patients from any device-related toxic, physiological, immunogenic, or mutagenic impacts. Biocompatibility testing can help with this.
Biocompatibility in medical devices is, by definition, a measurement of how compatible a device or material is with a biological system. The ISO 10993-1: 2018 standard defines biocompatibility as the “ability of a medical device or material to perform with an appropriate host response in a specific application.
What we covered in this webinar:
- Introduction to Biocompatibility
- Need for Biocompatibility
- Biological Evaluation of Medical Device
- Introduction to ISO-10993-1 Outline of the Biocompatibility
- Endpoints for Evaluation as per ISO 10993-1
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