Medical devices require varying degrees of biological safety testing, according to their classification and use. The main source of guidance on the essential requirements for biological safety is ISO 10993 - Biological evaluation of medical devices.
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Biocompatibility testing and evaluations for medical devices is a vital component of patient safety, for it is the only effective means to ensuring that a medical device or any related material, when it happens to come into contact with the patient's body has to not only perform its intended purpose and function; it should also not result in adverse reactions for the patient.
When medical devices and/or materials come into contact with the patient's body, they can cause problems or what may be termed adverse effects that can be either short-term or long-term adverse effects to the body.
These effects, called acute to chronic, can result in mutagenic effects.
It is to prevent the occurrence of such events that biocompatibility testing and evaluations for medical devices has to be carried out.
These evaluations for biocompatibility of medical devices are done to evaluate the interaction between a device and anything it comes into contact with within the patient's body, such as cells, tissue or body fluids.
Essentially, device biocompatibility is assessed to prevent biological risks from happening to the patient.
