Biological evaluation is done to measure the biological compatibility of medical devices with biological systems. Evaluation is performed using a sequence of tests mentioned in many international and national standards and guidelines concerning biological evaluation. Biological evaluation is performed based on their medical device classification according to the medical device nature and duration of their anticipated contact with human tissue when in use and biological endpoints are thought to be in consideration with the medical device category.
The biological evaluation of any substance or medical device intended for use in human’s beings shall form part of a structured biological evaluation plan within a risk management process in accordance with ISO 14971. A biological evaluation plan shall be planned adequately and documented by an experienced professional.
The rigor necessary in the biological evaluation is mainly determined by the use, degree, frequency, and duration of use of the exposure and the hazards identified for the medical device or material. Testing is usually not necessary when sufficient information is already available with the medical device manufacturer to perform a risk assessment of the material and/or the medical device. The biological safety shall be evaluated by the manufacturer over the entire life-cycle of a medical device.
The risk management documentation should also specify the biological hazards associated with the medical devices. Evaluation can include both a review of relevant existing preclinical and clinical data and actual testing data held by medical device manufacturer.
Following shall be the considered during biological evaluation:
Biological evaluation plan is developed to ensure that all the risks are addressed, as per the ISO 10993-1:2018 the biological evaluation of any material or medical device intended for use in humans shall form part of a structured biological evaluation plan within a risk management process in accordance with ISO 14971.
Biological evaluation plan is developed prior to testing as this can minimize unnecessary testing, maintain compliance with all pertinent standards/regulations and provide evidence for the ultimate goal of ensuring product safety.
As per section B.2.2 of ISO 10993-1:2018 the biological evaluation plan should be drawn up by a knowledgeable and experienced team and include as a minimum
A biological evaluation report (BER) is a collective summary of biological test performed and justifications for not performed test used to demonstrate how compatible a medical device is with the human body. In other words, the BER provides evidence of a medical device’s biological safety, known as biocompatibility.
Biological evaluation report also includes;
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