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Product Dose Mapping Per ISO 11137

(1-010-20)

This testing provides a three dimensional map of the dose received throughout the product/package during irradiation. Not less than 12 dosimeters are located in areas where the lowest and highest doses are likely to occur. Additional surface dosimeters are attached to provide the reference for production runs. Three test runs are made to determine the reproducibility and uniformity of the dose delivery. Part of the process is to work with the customer to determine the optimum packaging to minimize variability and processing costs. A report includes raw data with the internal dose levels referenced to the external target data. The report also recommends a target surface dose and process limits. NUTEK documentation is created to assure that the intended dose is delivered in routine production. Product dose mapping is requirement for irradiation validation in ISO 11137.