Introduction
Medical devices play a crucial role in modern healthcare, but their safety and compatibility with the human body are paramount. Biocompatibility testing lab is an essential process that ensures medical devices do not cause adverse effects when in contact with human tissues or fluids. At Sigma Test & Research Centre, we provide comprehensive biocompatibility testing services to guarantee that medical devices meet regulatory requirements and ensure patient safety.
This blog will explore what biocompatibility testing is, its importance, types, and how it is conducted.
What is Biocompatibility Testing?
Biocompatibility testing assesses the ability of a medical device or material to perform its intended function without causing undesirable local or systemic effects in the human body. It is a critical step in the development and approval process of medical devices, ensuring they are safe for patient use.
The testing process evaluates the interaction between medical device components and biological systems. Various regulatory bodies, including the U.S. Food and Drug Administration (FDA) and ISO 10993, have established guidelines to standardize biocompatibility testing methods.
