ISO 11137-3 Sterilization of Health Care Products - Radiation - Guidance on Dosimetric Aspects of Development, Validation and Routine Control

Material Testing

ISO 11137-3 Sterilization of Health Care Products - Radiation - Guidance on Dosimetric Aspects of Development, Validation and Routine Control

This standard provides guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and ISO/TS 13004 for dosimetry and its use in the development, verification and routine control of the radiation sterilization process.

ISO 11137-3 Sterilization of Health Care Products - Radiation - Guidance on Dosimetric Aspects of Development, Validation and Routine Control

The term "dose measurement" is used herein as a general term to indicate the determination of absorbed dose. It can refer both to a direct dose measurement with a dosimeter at the site, and to an indirect dose measurement of calculating the dose absorbed at a distance from a directly measured dose by applying factors.

Factors associated with an indirect dose measurement are usually determined during operational capability and performance qualification studies and reflect dose rates at different locations for a given irradiation process. If the factors and their associated uncertainties have been determined using traceable dose measurements, the indirect measurement itself can be considered traceable and will meet the requirements of ISO 11137-1 for measurement traceability and uncertainty.

Dosimetry systems used in the development, validation and routine control of the radiation sterilization process must be able to provide accurate and precise measurements across the entire relevant dose range and conditions of use.

EUROLAB assists manufacturers with ISO 11137-3 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.

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