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Biological Evaluation of Medical Devices (ISO 10993-1)- An Overview

Biological Evaluation of Medical Devices (ISO 10993-1)- An Overview

Biocompatibility is one of the important factor in assessing the safety of a medical device in their intended environment. It is the responsibility of a medical device manufacturer to evaluate the device for its biological safety prior to launch a product into the market. This paper is intended to give an Overview on Biological evaluation of medical devise i.e., risk approach, classification of devices and test procedures according to ISO 10993-1. Even though every country has its own standard for biological evaluation, understanding basic procedures for biological evaluation plays significant role to achieve human safety and clearance from authorities to market a medical device.

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