Medical Devices

BIOCOMPATIBILITY ASSESSMENT

Medical device manufacturers use data obtained from various analytical, in vitro, and in vivo (animal) test procedures to demonstrate the safety and effectiveness of their products. The ISO 10993 standard series outlines the basic biocompatibility test requirements for medical devices.

BIOCOMPATIBILITY TEST METHODS

There are some specific procedures recommended for biocompatibility testing. The following tests do not imply that all procedures are required for any particular device or that these are the only tests available.

1. Cytotoxicity (Cell Culture): This test uses cell cultures to determine whether a medical device or its components have a toxic effect on cells.
2. Sensitization Tests: These tests evaluate the potential of a device or its components to cause allergic reactions.
3. Irritation Tests: These are evaluations performed to determine whether the medical device causes irritation to the skin or mucous membranes.
4. Acute Systemic Toxicity: This test is performed to assess the risk of short-term systemic toxic effects caused by substances released from the device.
5. Subchronic Toxicity: A test that evaluates the toxic effects of a medical device or its components over the medium term (usually between 28 and 90 days).
6. Genotoxicity (Mutagenicity): A test conducted to analyze the potential of substances released from a device to cause damage or mutation in genetic material.
7. Implantation Tests: A test conducted to evaluate the biological compatibility and potential local effects of a medical device when implanted into tissue.
8. Hemocompatibility (Hemolytic Effect % HO): Tests conducted to evaluate the effect of a device on blood cells (hemolysis, coagulation, etc.) and its compatibility with blood.
9. Carcinogenicity: An assessment conducted to determine the risk of cancer caused by substances released from the device in the long term.
10. Reproductive and Developmental Toxicity: A test conducted to examine the potential harmful effects of the device or its components on reproductive system health and fetal development.
11. Pharmacokinetics (ADME): Tests that evaluate the absorption, distribution, metabolism, and excretion processes of substances released by the device in the body.
12. Preclinical Safety Testing (Chemical Characterization): A preliminary evaluation test that analyzes the chemical composition of a medical device to identify potential risks in terms of biological safety.
13. Histopathology Services (Microscopy, Clinical Chemistry): A detailed evaluation process that uses microscopy and biochemical analysis techniques to examine the effects of medical devices on tissues.

Nano-lab Laboratories Group continues to provide services within the scope of Medical Device Analysis.

For more information, please contact us.

Cytotoxicity

Sensitization

Irritation

Systemic Toxicity

Subchronic Toxicity

Genotoxicity

Implantation

Blood Compatibility

Chronic Toxicity

Carcinogenicity

Surface Devices

Skin

< 24 Hours

X

X

X

24 Hours – 30 Days

X

X

X

> 30 Days

X

X

X

Mucosal Membrane

< 24 Hours

X

X

X

24 Hours – 30 Days

X

X

X

O

O

O

> 30 Days

X

X

X

O

X

X

O

O

Deteriorated or Damaged Surface

< 24 Hours

X

X

X

O

24 Hours – 30 Days

X

X

X

O

O

O

> 30 Days

X

X

X

O

X

X

O

O

Devices with External Contact

blood, non-direct

< 24 Hours

X

X

X

X

X

24 Hours – 30 Days

X

X

X

X

O

X

> 30 Days

X

X

O

X

X

X

O

X

X

X

Tissue/Bone/Tooth Contact

< 24 Hours

X

X

X

O

24 Hours – 30 Days

X

X

X

X

X

X

X

> 30 Days

X

X

X

X

X

X

X

X

X

Blood circulation

< 24 Hours

X

X

X

X

O

X

24 Hours – 30 Days

X

X

X

X

X

X

X

X

> 30 Days

X

X

X

X

X

X

X

X

X

X

Implant Devices

Tissue/Bone

< 24 Hours

X

X

X

O

24 Hours – 30 Days

X

X

X

X

X

X

X

> 30 Days

X

X

X

X

X

X

X

X

X

Able to

< 24 Hours

X

X

X

X

X

X

X

24 Hours – 30 Days

X

X

X

X

X

X

X

X

> 30 Days

X

X

X

X

X

X

X

X

X

X

X: Result of tests according to ISO 10993-1
O: Final tests according to FDA