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  • ASTM
    E3464-25 Standard Guide for Performance Qualification (PQ) Dose Mapping in Gamma Irradiation Processing Facilities
    Edition: 2025
    $144.00
    Unlimited Users per year

Description of ASTM-E3464 2025

ASTM E3464-25

Active Standard: Standard Guide for Performance Qualification (PQ) Dose Mapping in Gamma Irradiation Processing Facilities




ASTM E3464

Scope

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.


Keywords

absorbed dose; dose distribution; dose mapping; dose zone; dosimetry; gamma radiation; irradiator characterization; maximum dose; minimum dose; operational qualification; performance qualification; photons; radiation processing; routine process monitoring; sterilization; uncertainty;


ICS Code

ICS Number Code 11.080.99 (Other standards related to sterilization and disinfection)


DOI: 10.1520/E3464-25



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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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