ISO 17665-1 Sterilization of Health Care Products - Moist Heat - Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 17665-1 testing. ISO 17665-1 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.

Moist heat sterilization processes within ISO 17665-1 include, but are not limited to:

• Saturated steam ventilation systems;
• Saturated steam active air evacuation systems;
• air vapor mixtures;
• water spray;
• Immersion in water.

This part of ISO 17665 does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.

This part of ISO 17665 does not apply to sterilization processes that rely on a combination of moist heat with other biocidal agents (eg formaldehyde) as the sterilizing agent. It also does not specify occupational safety requirements for the design and operation of moist heat sterilization plants.

EUROLAB assists manufacturers with ISO 17665-1 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.