ISO Acute Systemic Toxicity Study – Extract

ISO Acute Systemic Toxicity –  Testing of extracts evaluates whether chemicals leached from a medical device can cause harmful effects throughout the body after a single exposure. This in vivo test is typically conducted using rodents and involves injecting extracts of the device into the animal to observe systemic responses such as lethargy, weight loss, or death. It is a critical part of biocompatibility assessments for devices that contact blood, tissue, or mucosal surfaces, ensuring that no toxic substances are released during use.

Why This Testing is Performed

This test is conducted to:

• Detect acute toxic effects caused by leachable substances from medical devices.
• Ensure patient safety by identifying systemic risks from device materials.
• Fulfill regulatory requirements for biocompatibility, especially for devices with direct body contact.
• Support product development and premarket submissions by demonstrating safety under ISO 10993 guidelines .

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Steps in Conducting This Test

1. Extract Preparation: The device is extracted in a suitable solvent (e.g., saline or vegetable oil) under controlled conditions per ISO 10993-12.
2. Animal Dosing: The extract is administered to rodents via intravenous or intraperitoneal injection.
3. Observation Period: Animals are monitored for 72 hours for signs of toxicity such as behavioral changes, weight loss, or mortality.
4. Evaluation: Clinical observations and necropsy findings are used to assess systemic toxicity.
5. Interpretation: Results are compared to control groups to determine if the device extract causes adverse systemic effects.

Standards, Guidance, and Regulations

• ISO 10993-11: The primary standard for systemic toxicity testing, including acute, subacute, and chronic evaluations.
• ISO 10993-12: Specifies sample preparation and extraction protocols.