Acute Systemic Toxicity Tests: Medical Devices

Biocompatibility Test Methods for Medical Devices (ISO 10993 Series)

What is Acute Systemic Toxicity?

Acute systemic toxicity is defined as the systemic toxic effects that a medical device or substances released from it may cause in the body as a result of a single or short-term exposure. These effects may occur through direct use of the device or indirectly through the spread of ingested substances into the blood, organs or nervous system.

This type of toxicity can usually be manifested by the following symptoms

• Liver and kidney damage
• Neurological effects (e.g. seizures or loss of consciousness)
• Disorders of the respiratory or cardiovascular system
• Abnormalities in the structure or number of blood cells

ISO 10993-11 Standard and Acute Systemic Toxicity Tests

ISO 10993-11 regulates the toxicological tests required for the biological evaluation of medical devices. Acute systemic toxicity tests within the scope of this standard are used to detect adverse effects that devices or materials may have on the human body in the short term.

Purpose of the Test

• To determine whether the medical device or its materials cause systemic toxic reactions in the body.
• To ensure the safety of users in case of short-term exposure.
• To anticipate immediate health risks that may occur in the clinical use of the device.

Evaluation of Acute Systemic Toxicity Tests

Acute systemic toxicity test results provide an assessment of the systemic effects that the device may have on the body in the short term. In this evaluation

1. Dose-Response Relationship:
• It is determined whether the tested substance produces a toxic effect at a given dose.
• The no-effect dose level (NOAEL - Harmless Effect Level) is determined.
2. Clinical Findings:
• Body weight loss, behavioral changes, and clinical symptoms are evaluated.
• Organ damage and changes in blood values are analyzed.
3. Histopathological Findings:
• Organs are examined under a microscope and structural defects are determined.

Contribution of Acute Systemic Toxicity Tests to Medical Device Safety

Acute systemic toxicity testing plays a critical role to ensure the safety of medical devices. The contributions of these tests are:

1. Patient Safety:
• Eliminates the possibility that the device could harm human health in the short term.
2. Legal Compliance:
• Proves compliance with international standards such as ISO 10993-11.
• Ensures the device meets regulatory requirements such as CE marking or FDA approval.
3. Reducing Risks of Clinical Use:
• Early detection of acute toxic effects allows for device remediation before market introduction.
4. Consumer Confidence:
• Positive test results increase user confidence that the device is safe.

Nanolab Laboratories Group continues to provide services within the scope of Medical Device Analysis.

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