Biological Safety Evaluation

Medical device manufacturers aim is to manufacture medical devices which provide maximum health benefits to patients. At the same time, it's their responsibility to minimize the risk from the device. Hence, the medical device manufacturer should ensure that their product meets the stringent requirement of Biocompatibility tests. Biocompatibility testing measures the compatibility of material or medical devices with a biological system. The various endpoints considered in the biocompatibility tests are to prove that the materials or the devices are not toxic or non-injurious and do not cause any immunological rejection when used in association with tissues or a living system. The process of evaluating these risks is called biological safety evaluation. The Biological safety evaluation is performed per the guidelines ISO 10993, which is a part of the risk management process in accordance with ISO 14971. The method of biological safety evaluation can be divided into three distinct phases. 

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A) Identification of Risk (Biological Evaluation Plan (BEP)) 

B) Estimation of Risk through testing (Biocompatibility tests).

C) Determination of their acceptability (Biological Evaluation         Report (BER))