How To Meet Requirements Of Biocompatibility Testing?

 Biocompatibility testing is an important part of medical device development that ensures the safety and effectiveness of a device before it can enter clinical trials. The general goal of biomaterials testing is to ensure that materials used in medical devices are non-toxic, non-inflammatory, and not able to break down into any toxic fragments during normal use. 

 


 

Biocompatibility testing has become more rigorous over time as regulators have recognized the risks posed by untested or poorly tested devices. Failure to meet any of these standards may require you to make additional changes before you can proceed with the commercialization of your device. These days biocompatibility for medical devices testing has become mandatory.

 

·         Cytotoxicity – ISO 10993 Part 5

 

The cytotoxicity test is designed to determine whether material or device is toxic to human cells. This test is often performed on the materials used to make the device itself, but can also extend to include any fluids or substances used in or with the device. To pass this test, your device or material must have a CTU result of less than 10,000. 

 

·         Irritation – ISO 10993 Part 10

 

The irritation test is designed to evaluate the potential for a device to cause skin irritation when in contact with human skin. This test is usually performed on the materials used for the device casing, or the portion of the device in direct contact with the skin. Results are usually expressed as Irritation Units (IU). To pass this test, your device must have an IU result of less than 2. 

 

·         Hemocompatibility – ISO 10993 Part 4

 

The hemocompatibility test is designed to determine whether a device or material would impede the flow of blood. Results are usually expressed as Hemolytic Units (HU). To pass this test, your device must have a HU result of less than 2. 

 

·         Sensitization – ISO 10993 Part 10

 

The sensitization test is designed to determine whether a device or material would cause an allergic response in human tissue. Results are usually expressed as Human Sensitization Units (HSU). To pass this test, your device must have an HSU result of less than 10. 

 

·         Toxicity – ISO 10993 Part 11

 

The toxicity test is designed to determine whether a device or material is toxic to human cells. This test is often performed on the fluids or substances used in or with the device. Results are usually expressed as Toxic Units (TU). To pass this test, your device must have a TU result of less than 10. 

 

Biocompatibility testing is an important part of the medical device R&D process. The general goal of these tests is to ensure that materials used in medical devices are non-toxic, non-inflammatory, and not able to break down into any toxic fragments during normal use. 

 

If you are developing a new device and are not sure which biocompatibility tests are required, several labs offer biocompatibility services for medical devices. This service can help you identify which tests are required, but it will also allow you to collect samples for these tests before you make any significant investments in the commercialization of your device. The specific requirements for each test are outlined by ISO 10993.

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