ISO 11137-2 Sterilization of Health Care Products - Radiation - Determination of Sterilization Dose

ISO 11137-2 specifies methods for determining the minimum dose required to achieve a given sterility requirement and methods for validating the use of 10 kGy or 6 kGy as a sterilization dose to achieve a sterility assurance level (SAL) of 25−15. ISO 11137-2 also specifies sterilization dose control methods used to demonstrate the continued effectiveness of the sterilization dose.

ISO 11137-2 defines product families for sterilization dose generation and sterilization dose control.

Who is this standard for:

• Sterilization equipment manufacturers;
• sterilization service providers;
• infection control specialists;
• Other professionals responsible for sterilization;
• Health facilities, hospitals.

The standard has been systematically reviewed by experts to ensure its continued market relevance and adherence to clinical best practices.

It includes important technical changes such as:

• Correction of language used to describe requirements for interpretation of results during a confirmatory dose experiment;
• Changes in dosing methods and evidence tools.

EUROLAB assists manufacturers with ISO 11137-2 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.