Exciting Development in Medical Device Sterilization: ISO 17665:2024 Released!
There was an important development for the medical device industry in March. The 2024 revision of the ISO 17665 standard has been published and new criteria have been introduced for moist heat sterilization processes.
ISO 17665 is the gold standard for sterilizing non-sterile medical devices. It aims to completely eliminate microbiological contaminants through approved and controlled processes.
It provides manufacturers with a comprehensive framework for implementing effective sterilization techniques for patient and product safety. It is also an important guide for quality and regulatory compliance.
Standard; It improves device safety and sterility and promotes consistency and reliability in sterilization processes.
Developed by ISO's Technical Committee in collaboration with the European Committee for Standardization, this updated standard brings together previous editions into a single, modern guide, reflecting international consensus and new technical developments.
The 2024 revision simplifies and updates requirements for medical device sterilization while expanding scope.
It is essential that manufacturers and healthcare providers carefully review and implement these latest guidelines to maintain the highest standards of sterility.
Compliance with ISO 17665:2024 is not just a rule but a commitment to excellence in healthcare safety. As the medical device industry, it is critical that we embrace this standard to continue providing safe and effective products.