ISO 22442-1 Medical Devices Using Animal Tissues and Derivatives - Test Standard for the Practice of Risk Management

This standard applies to medical devices other than in vitro. In conjunction with ISO 14971, it specifies a procedure for identifying hazards and hazardous situations associated with such devices, anticipating and evaluating emerging risks, controlling those risks, and monitoring the effectiveness of that control. It also outlines the decision process for residual risk acceptability, taking into account the residual risk balance and expected medical benefit compared to available alternatives, as defined in ISO 14971.

This standard aims to provide requirements and guidance on risk management related to hazards specific to medical devices manufactured using animal tissues or derivatives such as:

• Contamination with bacteria, molds or yeasts;
• contamination with viruses;
• Contamination by agents causing contagious spongiform encephalopathies (TSE);
• Material responsible for undesired pyrogenic, immunological or toxicological reactions.

Similar principles may apply for parasites and other unclassified pathogenic entities. This standard does not specify a quality management system for the control of all stages of the production of medical devices. This standard does not cover the use of human tissues in medical devices.

EUROLAB assists manufacturers with ISO 22442-1 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.