The clinical performance of medical devices, in addition to fulfilling the intended use requirements; It is measured by causing an unexpected effect on the patient and being biocompatible when it comes into contact with the patient's body. Besides, the concept of biocompatibility; During the contact of the medical device with the patient's body, except for the reactions determined for the intended use or the operating mechanism; It is defined as having no side effects or stagnation.

Biocompatibility Tests of Medical Materials

GEN162 - Cytotoxicity Tests (ISO 10993-5)

GEN163 - Sensitization Test (ISO 10993-10, Guine Pig Max Test (OECD TG 406))

GEN164 - Irritation or Subcutaneous Reaction Test (ISO 10993-10)

GEN165 - Acute Systemic Toxicity Test (ISO 10993-11)

GEN166 - Subacute Systemic Toxicity (ISO 10993-11)

GEN207 - Subchronic Systemic Toxicity (ISO 10993-11) 

GEN208 - Chronic Systemic Toxicity (ISO 10993-11)      

GEN167 - Genotoxicity Test - Bacterial Back Mutation Ames Test (ISO 10993-3 (OECD TG 471))

GEN169 - Implantation Test (ISO 10993-6)

Chemicals and Cosmetics Biocompatibility Tests

GEN184 - Acute Oral Toxicity - Acute Toxic Class Method (OECD TG 423)

GEN194 - In vitro EpiDerm ™ Skin Irritation Test (OECD TG 439)

GEN195 - In vitro EpiDerm Skin Corrosion Test (OECD TG 431)

GEN 197 - In Vivo Acute Eye Irritation / Corrosion Test (OECD TG 405)

GEN 201 - Acute Oral Toxicity - Single Dose Protocol (OECD TG 420)

GEN 202 - 28-day Oral Toxicity Test at Repeated Dose (OECD TG 407)

GEN 203 - Genotoxicity Test - In Vitro Komet Test

Biocompatibility performances and tests of medical materials ISO 10993 Biological evaluation of medical materials is subject to the standard series. Although the ISO 10993 standard series is the most widely accepted biocompatibility test reference worldwide; In some other countries (eg China, America, Canada) biocompatibility testing requirements may vary.

Biomaterials are natural or artificial materials used to fulfill or support the functions of living tissues in the human body. In line with this aim, intensive efforts are being made to develop new materials.

Biomaterials designed to be partially or wholly assigned to organs and tissues to be implanted in a living system; be biologically compatible, non-toxic and carcinogenic, chemically inert and stable, have sufficient mechanical strength, be able to adapt to a busy life, appropriate weight and density. In addition, physical, chemical, mechanical, thermal properties are well known and tissue and allergic, toxic, carcinogenic reaction is desired.

The ability of the medical devices developed in this context to provide biocompatibility to human tissues becomes clear only after tests.

In every region of the world, medical device manufacturers are obliged to prove the biocompatibility performance of their products. Mostly, biocompatibility performance of medical materials ISO 10993-1 Biological evaluation of medical materials - ISO 10993-1: 2009 Part 1: In a risk management process, it is selected in accordance with the classification of the device specified in the assessment and testing standard and is evaluated in the most general sense according to the following biological effects:

1. Genotoxicity test; the medical device, the genetic information in the cells of the patient's body mutagenic, carcinogenic and teratogenic (birth malformations) and so on. determines whether it has any effect; Genotoxicity test ISO 10993-3 Biological assessment of medical equipment - Part 3: Subject to the test standard for genotoxicity, carcinogenicity and reproductive toxicity.
2. Blood compatibility test; measurements of biological effects such as hemolysis (breakdown of blood cells), thrombus formation, effects on immune system in patient's blood cells. Blood compatibility test ISO 10993-4 Biological evaluation of medical equipment - Part 4: Selection of blood interaction experiments is subject to the standard.
3. Cytotoxicity test; It is a test that evaluates the effects of cell death on the life cycle of cells in the patient's body, such as cell death, inhibition of cell growth. Cytotoxicity test 10993-5 Biological evaluation of medical devices - part 5: Subject to the standard of extracorporeal cytotoxicity assays.
4. Implantation test; Medical materials that fall into the category of implant; This is a test performed to investigate local effects after implantation. "Implantation" test ISO 10993-6 Biological evaluation of medical equipment - Part 6: Subject to the standard of tests for local effects after implantation.
5. Irritation and skin sensitization test; Biological assessment of medical devices ISO 10993-10 which determines whether the medical device causes any irritation or sensitization reaction in the patient body - Part 10: Tests for irritation and skin sensitivity (ISO 10993-10: 2010).
6. Systemic toxicity tests; Tremor is called tests that measure whether the medical device causes a systemic effect such as changes in body weight and body temperature in the patient body. Systemic Toxicity Tests, ISO 10993-11 Biological evaluation of medical equipment - Part 11: Subject to the standard of systemic toxicity tests.
7. Material and chemical characterization test; if there are combined medical devices (that is, if the device is to be used in combination with any medication to achieve its purpose) and / or substances that may leak into the patient's body system; tests to identify and investigate the safety of these substances. These tests are subject to the ISO 10993-18 Biological evaluation of medical devices - Part 18: Standard for determination of chemical properties of materials.

Apart from the most common tests mentioned above, additional tests may be required according to the classification of the medical device.

• ISO 10993-16 for biodegradable medical devices Biological evaluation of medical materials - Part 16: Toxicokinetic studies within the scope of the toxicokinetic study design for decomposition products and extractable products or
• ISO 10993-13 Specified specifically for polymeric medical devices Identification and quantification of degradation products resulting from polymeric medical devices
• For ceramic medical devices; ISO 10993-14 Biological evaluation of medical materials - Part 14: Identification and quantification of decomposition products from ceramics and
• Biological evaluation of medical devices - ISO10993-15 for medical devices with raw materials metals and alloys - Part 15: In accordance with standards for the identification and quantification of decomposition products from metals and their alloys; identification and quantification of leaking materials.

The following table shows the required biocompatibility tests of medical devices in accordance with body contact and contact time. Finally, it should be noted that “biocompatibility tests gerekti should be applied to the finished product.

X = Tests specified in ISO 10993-1 standard

ϴ = Tests to be applied to the US (FDA) market

Note1 = Tissue includes tissue fluid and subcutaneous space.

Note2 = For all devices involved in extracorporeal circulation

Biocompatibility tests; Cytotoxicity, material and chemical characterization tests, and other blood compatibility tests except thrombus formation are carried out mostly on animals. The number of animals to be used in each biocompatibility test is different depending on the content of the test. Similarly, the duration of each biocompatibility test differs from each other.

You can take biocompatibility tests from our laboratory EUROLAB.