ISO11137sarja

ISO 11137 series refers to a set of international standards for the validation and routine monitoring of sterilization processes using ionizing radiation. The standards are issued by the International Organization for Standardization (ISO) and provide a framework for the sterilization of medical devices and other healthcare products.

The ISO 11137 series consists of several parts, each addressing a specific aspect of radiation sterilization. ISO 11137-1 provides general principles and a guide for the validation of radiation sterilization processes, while ISO 11137-2 focuses on the biological indicators for the detection of sterilization. ISO 11137-3 and ISO 11137-4 offer guidance on the routine monitoring and control of radiation sterilization processes.

The main purpose of the ISO 11137 series is to ensure the sterility of medical devices and other healthcare products. The standards provide a quality assurance framework for radiation sterilization processes, ensuring that products undergo effective sterilization and reducing the risk of contamination.

The application of ISO 11137 series standards extends to various industries, including medical device manufacturers, hospitals, and healthcare providers. The standards provide a common framework for the validation and monitoring of radiation sterilization processes, promoting international consistency and cooperation.

The ISO 11137 series has undergone revisions over time, with new parts and editions published to reflect advances in technology and industry needs. The standards continue to evolve, ensuring that radiation sterilization processes comply with changing regulatory requirements and industry best practices.