Systemic toxicity studies for medical devices by ISO 10993-11

As part of a medical device's biocompatibility evaluation, systemic toxicity tests following ISO 10993-11 are used to assess the risk of the device or its components causing harmful effects throughout the body upon use. Systemic toxicity refers to effects that may be observed when the device or its particles enter the body and affect multiple organs or systems, rather than a specific contact site.

Systemic toxicity can be evaluated through studies of:

• Acute systemic toxicity (exposure up to 24 hours)

• Subacute systemic toxicity (exposure >24 hours up to 28 days)

• Subchronic systemic toxicity (exposure for part of the lifespan)

• Chronic systemic toxicity (exposure for a major part of the lifespan)

The most appropriate study type depends on factors like administration route, exposure time, and frequency, which should be justified according to the device's intended use. All the tests are typically in vivo animal studies, and samples should be prepared following ISO 10993-12.

In toxicity studies, the tested device or its extract is administered or injected into the animal via the most clinically relevant route (dermal, implantation, inhalation, intradermal, intramuscular, intraperitoneal, intravenous, oral, or subcutaneous administration). Exposed animals are then evaluated through clinical pathology, histopathology, and/or gross pathology.

• Acute systemic toxicity assesses the effects of single, multiple, or continuous exposures up to 24 hours and is often conducted on rodents (mice, rats).

• Subacute, subchronic, and chronic systemic toxicity are relevant when the device is expected to be in contact for prolonged or continuous periods, and testing is typically conducted on rats or rabbits.

Systemic toxicity tests provide crucial safety information by identifying potential harmful effects caused by the medical device.

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