Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)

This standard provides guidelines for the control of the source, collection, and processing of animal tissues and their derivatives used in medical devices. It outlines requirements to ensure the safety and quality of these materials throughout their lifecycle. The document focuses on the procedures necessary to maintain traceability and compliance with relevant regulations. It includes specifications for handling, storage, and transportation to prevent contamination and ensure product integrity. Additionally, it addresses the documentation and verification processes required to demonstrate adherence to established standards. The content is structured to support manufacturers and regulatory bodies in maintaining consistent practices across the industry.