Biocompatibility Tests

The concept of biocompatibility refers to the interaction between the tissues and physiological systems of the patient being treated with a medical device. The biocompatibility assessment is part of the overall safety assessment of a device.

Biocompatibility Tests

Biocompatibility of medical devices is being investigated using analytical chemistry, in vitro tests and animals. The biocompatibility of a device mainly depends on the following factors:

  • Chemical and physical structure of component materials

  • Tissue types of the patient to be exposed to the device

  • Exposure time to this device

The biocompatibility assessment of a medical device is actually performed to ensure patient safety. When programming a biocompatibility test, manufacturers must consider their objectives and compliance risks. In fact, evaluating the biocompatibility of a medical device is a risk assessment study. All medical devices have some degree of risk. Companies designing medical devices are trying to maximize the benefits they provide to patients while minimizing these risks.

The main standard in biocompatibility testing is the ISO 10993 standard. This standard has been published in our country by Turkish Standards Institute (TSE) with the following title: TS EN ISO 10993 Biological evaluation of medical devices. The first part of this standard is the test selection guide. The second part includes animal welfare requirements. The following sections cover specific test processes and other test-related issues. The complete list of the standard is as follows:

  • Section 1: Evaluation and experiment

  • Chapter 2: Requirements for animal welfare

  • Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity

  • Section 4: Selection of blood interaction experiments

  • Section 5: Extracorporeal cytotoxicity assays

  • Part 6: Experiments for local effects after implantation

  • Section 7: Ethylene oxide sterilization residues

  • Section 8: Selection and characteristics of reference materials for biological experiments

  • Chapter 9: Preliminary study to identify and quantify potential degradation products

  • Section 10: Experiments for irritation and skin sensitivity

  • Section 11: Systemic toxicity tests

  • Section 12: Sample preparation and reference materials

  • Chapter 13: Identification and quantification of decomposition products of medical devices made of polymer

  • Chapter 14: Identification and quantification of degradation products from ceramics

  • Chapter 15: Identification and quantification of decomposition products from metals and their alloys

  • Chapter 16: Toxicokinetic study design for decomposition products and extractable products

  • Section 17: Determination of acceptable limits for leachable substances

  • Section 18: Chemical properties of materials

Biocompatibility testing data are almost always required for devices with significant tissue contact. The material biocompatibility matrix of the ISO 10993-1 standard is used to determine whether a medical device requires a biocompatibility test.

If the manufacturer holds data from previous shipments, data from material or component suppliers, analytical data, and clinical data, the number of tests is slightly reduced.

The main objective of the ISO standard is to verify that the device is suitable for its intended use. In this process, biological tests are the most critical step in biocompatibility assessment. The standard classifies devices according to body contact type and duration. It also provides a list of potential biological effects. Manufacturers must collect safety data for all components and materials used in a medical device.

Our company also provides biocompatibility testing services within the scope of certification services. Thanks to these services, enterprises are able to produce more efficient, high performance and quality products in a safe, fast and uninterrupted manner.

Biocompatibility testing services provided within the scope of certification services are only one of the services provided by our organization in this respect. Many other certification services are also available.

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