Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007)

This standard provides guidance on the application of risk management processes for medical devices that utilize animal tissues and their derivatives. It outlines the specific considerations and requirements necessary to ensure the safety and effectiveness of such devices throughout their lifecycle. The document focuses on the integration of risk management into the design and development phases, as well as during production and post-market activities. It addresses the identification, analysis, evaluation, and control of risks associated with the use of animal-derived materials. The standard also includes recommendations for the documentation and traceability of risk management activities. It is intended for use by manufacturers, regulatory authorities, and other stakeholders involved in the development and regulation of medical devices containing animal tissues.