ISO 10993-11 Biological Evaluation of Medical Devices Part 11: Systemic Toxicity Tests

EUROLAB laboratory provides testing and compliance services within the scope of ISO 10993-11 standard. This standard specifies requirements and provides guidance on the procedures to be followed in assessing the potential of medical device materials to cause adverse systemic reactions.

This document addresses the assessment of overall systemic toxicity, not specific target organ or organ system toxicity.

Due to the wide variety of medical devices and their materials and uses, this standard is not overly prescriptive. While addressing certain methodological aspects that should be considered in the design of systemic toxicity tests, appropriate study design must be uniquely tailored to the nature of the device's materials and its intended clinical application.

While some systemic toxicity tests (for example, long-term implantation or dermal toxicity studies) may be designed to study local, carcinogenic or reproductive effects as well as systemic effects, this standard only focuses on aspects of such studies that are intended to address systemic effects. Studies aimed at addressing other toxicological endpoints are covered in ISO 10993-3, ISO 10993-6, ISO 10993-10 and ISO/TS 10993-20.

EUROLAB assists manufacturers with ISO 10993-11 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.