The biological evaluation of medical devices takes a new direction.

[Aniket Chaudhari]

Biological evaluation is an essential part of medical device right from the beginning and there are lot of advancement happening as the progress in technology happens and the experience that gained over a period in this field.
It goes without saying that people got to be shielded from the potential biological risks that would arise from the utilization of medical devices, yet the range of biological hazards is wide and sophisticated. There is a standard existed BS EN ISO 10993-1-2009, and this was required to be followed as guideline however there were various separate method were used for actual evaluation depending on device type.
Recently EN ISO 10993-1:2020 – was published which covers the biological evaluation of medical devices within a risk management process as a part of the general evaluation and development of every medical device. This is mainly because international safety standard on medical device under risk management process also underwent massive revision.
It applies to the evaluation of materials and devices that are expected to possess direct or indirect contact with a patient’s body during intended use. However, note that it also applies to medical devices in direct or indirect contact with a tool user’s body, if the device is meant to guard the user: e.g., surgical gloves and masks.

The standard covers all medical devices contact or noncontact and implantable and non implantable. It also gives guidelines for the risk that may arise due to decomposition or breakdown of device and its exposure to body tissues.
BS EN ISO 10993-1:2020 - has been revised to reflect the very fact that as our understanding of the fundamental mechanisms of host responses advances, we will minimize the amount and exposure of test animals. thereto end the revised standard gives preference to chemical, physical, morphological, and topographical characterization testing and in vitro models wherever these methods produce equally relevant information thereto obtained from live animal testing.
The specific changes to the quality therefore include a significantly revised Annex A that has been changed to incorporate physical and/or chemical information as a part of the endpoints to be addressed during a biological risk assessment. This information has now become a prerequisite for any risk assessment. As well, Annex B on guidance on the danger management process has been replaced with “Guidance on the conduct of biological evaluation within a risk management process”.
There are some editorial changes also to make it clearer to understand.
It also covers on additional information on evaluation of non-contacting medical devices and new information on evaluation of transitory contact medical devices and additional information on evaluation of nanomaterials and absorbable materials.
In that way the standard and therefore the series as an entire can provide the simplest approach to protecting people connected with medical devices from biological risks.
However, this needs to be used by qualified and experienced professionals who can understand the guideline and apply the same.