Biocompatibility Testing Lab | ISO 10993 Testing Lab

Biocompatibility Testing Lab for Medical Device

Biocompatibility Testing Lab for Medical Device

What is biocompatibility testing?

Biocompatibility is, by meaning a measurement of how well-matched an appliance is with a biological system. The resolution of performing Biocompatibility Testing is to regulate the suitability of an appliance for human use, and see whether the use of the device can have any potentially harmful physiological results.    

How do you test the biocompatibility of a material?

The biocompatibility of material or extract through the application of the isolated cells in vitro. These techniques are beneficial in assessing the toxicity or irritancy likely of materials and chemicals. This technique provides an excellent way to screen materials prior to in vivo tests.

How much does biocompatibility testing cost?

The biocompatibility testing process can be long and costly. For most medical appliances, the procedure can take up to 10-12 weeks and may cost around $1500.

Why is biocompatibility testing important?

Biocompatibility Testing is essential because systemic toxicity impairs an entire biological system such as the immune or nervous system.

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What is Meant by Biocompatibility?

Biocompatibility is distinct as the ability of a material to perform with a specific host response in a particular application.

What Metals are Biocompatible?

Stainless steel, cobalt-chromium alloy, and titanium and its alloys are three premiere groups of biocompatible metals.

What makes a material biocompatible?

Biocompatible materials are planned and designed to edge with biologically active systems for evaluating, augmenting, treating, or altering any tissue, function, or organ of the body. Biomaterials are defined as the non-living materials used in medical devices intended to interact with biological systems.

Is Teflon Biocompatible?

PVDF, FEP, and PTFE are well-organized biocompatible materials, and their lubricity and chemical conflict make them the material of choice for products such as multi-lumen tubing and others that are used in slightly aggressive procedures.

Is ABS plastic Biocompatible?

Dissimilar ABS, PLA is a renewably resulting plastic. Therefore, it is biodegradable whereas ABS is only biocompatible. Nonetheless, like many plastic materials, ABS is recyclable.  

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Biocompatibility Testing of Medical Devices falls under ISO 10993. Before usage of any kind of device on a commercial basis for treatment, this test is done to check its effect on living tissues and gets verified by experts.

Biocompatibility Test covers a wide section of the test for the medical device including its toxicity level on exposure to living cells to heating up of mechanical parts and all other domains possible.

A medical device means to us to be any kind of device that scans, detects, treats, and responds to any kind of change in the physical body of a patient. Medical Devices thus range from a wide variety of hearing aid to bone implants to the age-old sphygmomanometer as well.

As mentioned earlier Biocompatibility testing ranges to a wide domain thus has a long procedure of testing that can be roughly differentiated into four stages. The stages are to be Initial Screening, Performance Testing, Non-Clinical Testing, and Safety Testing. Each component of the device is normally checked individually to determine its durability. The functioning of the device is taken to their extreme levels during the testing period to check their vulnerability. The effect of the device on a patient is checked as well by having a volunteer on whom the device gets to be used on an initial level. Toxicity levels of devices, especially those emitting radiations are checked as well to ensure that they do not harm the user’s body in the long run. As can be seen by this small description of the processes, this tenure of testing and verifying those test reports normally range quite a long time ranging from weeks to even months before the launch of the device to be used on a commercial level.

All the rules and regulations that are to be followed while these biocompatibility tests are vividly described in ISO 10993 that are necessary to be followed while the testings are done.

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