BS EN 17665

Significance

Sterilization is a patient safety factor that must be done well in health care. Issued by BS EN ISO 17665, the new guidance is a mathematical-based framework problem intended for use by the manufacturer to provide evidence that the moist heat sterilization process will adequately reduce microbiological contaminants from medical devices reliably. This standard will allow organizations to optimize patient safety, standardize regulatory considerations, improve risk management practices, and ensure consistent sterilization results. Early adoption also positions manufacturers advantageously ahead of anticipated harmonization with European medical device regulations, reducing the risk of costly, last-minute procedural overhauls.

Scope

BS EN ISO 17665 applies to the moist heat sterilization of medical devices in both industrial and healthcare facility settings. It covers each of the important aspects of the sterilization life cycle—process and product design, microbiological and physical process development, sterilization process validation, routine process monitoring, documentation control, management responsibility, resource allocation, and external product controls, as well as traceability and non-conforming product management. Covered in the standard are the principles of modern sterilization and how to develop effective sterilization cycles; therefore, it is applicable to manufacturers, sterilization service providers, and health care institutions that have responsibilities in device safety and sterility assurance.