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Standard Guide for Performance Qualification (PQ) Dose Mapping in Gamma Irradiation Processing Facilities
1.1 In this standard, guidance is provided on the procedure for conducting performance qualification (PQ) dose mapping at gamma irradiation facilities.
Note 1: For irradiation of health care and food products, specific International Organization for Standardization (ISO) standards exist for defining fundamental requirements. See ISO 11137 Part 1 for health care products and ISO 14470 for food products. This guide provides methods that can be used to meet the PQ requirements as defined in the relevant ISO standard.
1.2 Methods of analyzing the dose map data are described. Examples are provided of statistical methods that can be used to analyze dose map data.
1.3 Dose mapping for bulk flow processing and fluid streams is not discussed.
1.4 Dosimetry is an element of a total quality management system for an irradiation facility. Other controls besides dosimetry can be required for specific applications such as medical device sterilization.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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