ASTM E3239-21
Standard Guide for Using Statistical Process Control Principles for Routine Dosimetry in Radiation Processing

Standard No.

ASTM E3239-21

Release Date

2021

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM E3239-21

Scope

1.1 This document provides guidance for the statistical analysis of the irradiation process from dosimetric data. 1.2 This document is one of a set of guides and practices that provide recommendations for properly implementing dosimetry in radiation processing. It is intended to be read in conjunction with ISO/ASTM 52628 and ISO/ASTM 52303. 1.3 This document employs a set of standard statistical methods and is intended to be read in conjunction with Practice E2586, Practice E2281, Practice E2587, and ASTM Manual MNL72 . 1.4 This guide is applicable to high-energy electron beam, X-ray and gamma-ray irradiation processes. 1.5 This document assumes user knowledge of statistics, radiation processing, and radiation dosimetry. (See Annex A6) 1.6 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. 1.7 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.

ASTM E3239-21 Referenced Document

• ASTM E122 Standard Practice for Calculating Sample Size to Estimate, With a Specified Tolerable Error, the Average for Characteristic of a Lot or Process
• ASTM E2281 Standard Practice for Process Capability and Performance Measurement
• ASTM E2586 Standard Practice for Calculating and Using Basic Statistics
• ASTM E2587 Standard Practice for Use of Control Charts in Statistical Process Control*， 2024-04-21 Update
• ASTM E3083 Standard Terminology Relating to Radiation Processing: Dosimetry and Applications*， 2024-04-21 Update
• ASTM E456 Standard Terminology for Relating to Quality and Statistics
• ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
• ISO 11137-2 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1*， 2022-06-13 Update
• ISO 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
• ISO 11462-1 Guidelines for implementation of statistical process control (SPC) - Part 1: Elements of SPC
• ISO 16269-6 Statistical interpretation of data - Part 6: Determination of statistical tolerance intervals
• ISO 3534-1 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability
• ISO 3534-2 Statistics - Vocabulary and symbols - Part 2: Applied statistics

ASTM E3239-21 history

• 2021 ASTM E3239-21 Standard Guide for Using Statistical Process Control Principles for Routine Dosimetry in Radiation Processing