Biocompatibility for Medical Devices helps in Establishing a Good Communication
                     Biocompatibility for Medical Devices helps in 
Establishing a Good Communication Between 
Device and Cells
Medical devices or materials are expected to deliver their 
intended functionalities without causing any potential 
adverse reactions to a patient, ranging from acute to 
chronic effects to their body including mutagenic effects. 

That is why evaluation and Biocompatibility for medical 
devicesis very important for assessing the interaction 
between the device and cells, tissue and body fluids of 
patients. Biocompatibility testing is designed mainly for 
protecting the patient from biological risks.
The biocompatibility testing procedure follows three 
steps
·  Planning
In this stage, information about the materials that are 
used in manufacturing the device is collected, BEP 
(biological evaluation plan) is also developed for 
determining the kind of testing which is needed.
 · Testing
    This step begins with in vitro screening through 
cytotoxicity testing. Some other tests such as 
chemical characterization or extractable leachable 
testing are also performed prior to in vivo testing.
· Evaluating the data
In vitro Cytotoxicity
This biocompatibility test is conducted on cultured 
mammalian cells for evaluating the materials or toxicity 
as well as chemicals.
Chemical characterization
Chemical analysis and characterization of the components of a 
device is performed before any biological testing. In this process, 
leachable materials are extracted from the device at a high 
temperature and then analyzed using different instrumentations. 
Toxicological risk assessment is performed on those extracts for 
potentially toxic or harmful chemicals.
In vivo
Once in vitro testing is done, in vivo testing is conducted and the 
type of tests depends on the intended use of the device. In vivo 
biocompatibility testing includes sensitization testing, skin 
irritation testing, systemic toxicity testing and implantation testing. 
The duration for this testing can vary from couple of weeks to few 
months, based on the particular data required. Chronic or sub-
chronic systemic toxicity testing may take longer time.
Biocompatibility testing for dental materialscan be characterized 
by parameters including
· Mutagenicity
· Carcinogenicity
· Genotoxicity
· Cytotoxicity
· Histocompatibility
· Microbial effects
Though, adverse effects are not usual to dental materials, it 
is not impossible and can happen locally and 
systematically. A dentist should take the responsibility for 
accessing the risk of dental materials. Dental amalgam is a 
common problem that dental staff faces oftentimes. They 
can also be exposed to resin and latex based dental 
materials.
Note
As medical devices are associated with the well being of 
patients, it is the most important thing that they are tested 
properly and efficiently. Biocompatible medical devices are 
safe to use and they do not cause any adverse reaction to the 
patient.
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