Subchronic Toxicity: Systemic Safety of Medical Devices

Biocompatibility Test Methods for Medical Devices (ISO 10993 Series)

As medical devices are products that come into contact with or are used inside the human body, their safety needs to be comprehensively assessed. Subchronic toxicity tests are one of the important tests that assess the systemic effects of a medical device or substances released from the device on the human body in the medium term (between 28 and 90 days).

What is Subchronic Toxicity?

Subchronic toxicity is defined as the systemic toxic effects that a substance or device may cause in the organism as a result of continuous or repeated exposure for 28 to 90 days. These tests are particularly important for medical devices designed for long-term or repeated use.

Subchronic toxicity is usually examined in the following organs and systems:

1. Liver: As the main organ of detoxification, it is sensitive to toxic substances.
2. Kidneys: Can be directly affected by toxic effects as it is involved in the excretion of waste substances.
3. Blood and Bone Marrow: The production and circulation of blood cells can be affected by toxic substances.
4. Nervous System: Some chemicals can cause neurotoxic effects.
5. Immune System: Impairment of immune responses may occur.

ISO 10993-11 Standard and Subchronic Toxicity

ISO 10993-11 specifies the toxicological tests to be performed for the biological safety of medical devices. Subchronic toxicity tests are part of this standard and are performed specifically to assess the toxic effects that the device may cause in long-term use.

Objectives of the Test

• To determine whether medical devices or their components produce systemic toxic effects.
• To analyze the potential effects of medium-term exposure on organs and body systems.
• To prove that the device is safe for clinical use.

Contribution of Subchronic Toxicity Tests to Medical Device Safety

Subchronic toxicity testing makes the following critical contributions to ensure the systemic safety of medical devices and protect patient health:

1. Patient Safety: Predetermines the potential for the device to cause organ damage or toxic reactions in the medium term.
2. Regulatory Compliance: Ensures that medical devices are evaluated in accordance with international standards such as ISO 10993-11.
3. Reducing Clinical Risks: Testing minimizes risks by predicting potential toxic effects that may occur during use of the device.
4. Long-Term Safety of Use: Subchronic toxicity testing is important to confirm that the device is safe for long-term use.

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