ASTM 52303-24
Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities

Standard No.

ASTM 52303-24

Release Date

2024

Published By

American Society for Testing and Materials (ASTM)  US  /  ASTM

Status

Be replaced

Replace By

ASTM 52303-24e1

Latest

ASTM 52303-24e1

Introduction

Analysis of the core content of the standard

Scope of application and technical boundaries

This guideline applies to the absorbed dose distribution mapping of products, materials or substances in γ irradiation devices, X-ray (bremsstrahlung) facilities and electron accelerators.

• Food irradiation and radiation sterilization of medical devices should give priority to following special standards such as ISO/ASTM 51608 and 51702.
• Dose mapping for fluids and bulk materials is not within the scope of this discussion.

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Dose mapping implementation methods

Phase	OQ dose mapping	PQ dose mapping
Purpose	Characterization of irradiation facilities	Verification of specific product loads
Material requirements	Reference materials (density coverage range)	Actual product or equivalent simulant
Number of repetitions	≥3 times the same process load	≥3 times the same configuration
Key outputs	Dose uniformity ratio (DUR), process reproducibility	Relationship between maximum/minimum dose area and routine monitoring points

Special requirements for electron beam facilities

For electron beam facilities, the standard specifically emphasizes:

• Beam energy needs to be verified (300keV-25MeV range)
• Scanning uniformity test must be included in IQ
• Dose distribution maps need to be established separately for single/double-sided irradiation modes

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Technological Evolution and Standard Development

Compared with the 2015 edition, the 2024 edition has the following major updates:

1. Added special guidance for X-ray facilities (citing ISO/ASTM 51608)
2. Strengthened statistical process control requirements (refer to Guide E3239)
3. Clarified the analysis method for non-repetitive dose data (see Appendix X3)

The standard is planned to be comprehensively revised after the E61.03 Subcommittee completes the supporting documents. The current version adopts a transitional framework structure.

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Implementation Recommendations and Critical Control Points

Statistical Equivalence Determination of Dose Area

Standard Appendix X1 provides two statistical methods:

Method	Applicable Conditions	Calculation Points
Parametric Statistical Method	Small Sample Size (n≥3)	δ= k√(2S²/n) Based on t Distribution
Non-parametric Statistical Method	Large Sample Size (n≥100)	95% Quantile Value for Relative Difference Ranking

Uncertainty management requirements

• An uncertainty budget table
must be established, which includes factors such as calibration, dosimeter variation, and instrument reproducibility.
• It is recommended to use the method provided by ISO/ASTM 51707 to evaluate the combined uncertainty.
• The ratio estimation of the routine monitoring position and the limit dose point needs to take into account bias correction (see Appendix X2)

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Documentation requirements

Chapter 9 of the standard clearly stipulates that the following must be recorded:

1. Dose system traceability information (including batch number, calibration curve)
2. Irradiation environment parameters (temperature, humidity, etc.)
3. Product load characteristics (density, configuration, etc.)
4. Dose map analysis results (including statistical processing methods)

All records must be kept for the minimum period specified by the law. It is recommended to use an electronic management system to implement version control.

ASTM 52303-24 Referenced Document

• ASTM E178 Standard Practice for Dealing With Outlying Observations
• ASTM E2232 Standard Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications
• ASTM E3083 Standard Terminology Relating to Radiation Processing: Dosimetry and Applications*， 2024-12-01 Update
• ASTM E3239 Standard Guide for Using Statistical Process Control Principles for Routine Dosimetry in Radiation Processing
• ASTM E3270 Standard Guide for Operational Qualification of Gamma Irradiators
• ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices*， 2025-04-02 Update
• ISO 14470 Food irradiation - Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food
• ISO/ASTM 51261 Practice for calibration of routine dosimetry systems for radiation processing
• ISO/ASTM 51608 Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 keV and 7.5 MeV
• ISO/ASTM 51649 Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV
• ISO/ASTM 51702 Practice for dosimetry in a gamma facility for radiation processing
• ISO/ASTM 51707 Guide for estimation of measurement uncertainty in dosimetry for radiation processing
• ISO/ASTM 51818 Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
• ISO/ASTM 52628 Standard practice for dosimetry in radiation processing

ASTM 52303-24 history

• 2024 ASTM 52303-24e1 Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
• 2024 ASTM 52303-24 Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities

Standard and Specification