ISO/ASTM 51818:2020
Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 13
- Дата публикации:
- 30 июня 2020 г.
- Издание:
- ISO/ASTM IS 51818 edition 4 version 1
- ICS:
- 17.240
This practice covers dosimetric procedures to be followed in installation qualification, operational qualification and performance qualification (IQ, OQ, PQ), and routine processing at electron beam facilities to ensure that the product has been treated with an acceptable range of absorbed doses. Other procedures related to IQ, OQ, PQ, and routine product processing that may influence absorbed dose in the product are also discussed. The electron beam energy range covered in this practice is between 80 and 300 keV, generally referred to as low energy. Dosimetry is only one component of a total quality assurance program for an irradiation facility. Other measures may be required for specific applications such as medical device sterilization and food preservation. Other specific ISO and ASTM standards exist for the irradiation of food and the radiation sterilization of health care products. For the radiation sterilization of health care products, see ISO 11137-1. In those areas covered by ISO 11137-1, that standard takes precedence. For food irradiation, see ISO 14470. Information about effective or regulatory dose limits for food products is not within the scope of this practice (see ASTM F1355 and F1356). This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and describes a means of achieving compliance with the requirements of ISO/ASTM 52628. It is intended to be read in conjunction with ISO/ASTM 52628. 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. 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.
Abstract
Overview
ISO/ASTM 51818:2020 - Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV - provides guidance on dosimetric procedures used to qualify and control low‑energy electron beam (e‑beam) facilities. The standard covers dosimetry for installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) and routine processing, and addresses how to ensure products receive an acceptable range of absorbed dose. It emphasizes dosimetry as a key element of a wider quality assurance program and is intended to be used in conjunction with ISO/ASTM 52628.
Key topics and requirements
- Energy range and scope: Applicable to low‑energy electron beams (80–300 keV) used for surface treatments, curing, crosslinking and surface sterilization.
- IQ, OQ, PQ and routine monitoring: Describes dosimetric procedures required to demonstrate correct installation, proper operation and ongoing performance of e‑beam processes.
- Dosimetry systems: Selection, calibration and use of dosimeters (e.g., film, alanine) plus measurement instruments and procedures; importance of metrological traceability and calibration to national/international standards where required.
- Depth‑dose and beam characterization: Measurement of depth‑dose distributions, beam width, average beam current and conveying speed to relate machine parameters to absorbed dose in product.
- Uncertainty and documentation: Requirements for estimating measurement uncertainty, maintaining uncertainty budgets, and documenting results and procedures for routine process control.
- Limitations and precedence: Notes that ISO 11137‑1 takes precedence for health‑care product sterilization and ISO 14470 addresses food irradiation specifics; regulatory dose limits for food are out of scope.
Practical applications and who uses it
ISO/ASTM 51818:2020 is used by:
- Radiation processing engineers and facility managers operating low‑energy e‑beam equipment
- Quality assurance and validation teams performing IQ/OQ/PQ for irradiation lines
- Dosimetrists and metrology labs responsible for dose calibration, measurement traceability and uncertainty evaluation
- Manufacturers using e‑beam for surface sterilization, curing of coatings/inks, crosslinking films, or aseptic packaging
Practical benefits include reliable correlation of machine settings to absorbed dose, reproducible process control, and traceable dosimetry records that support regulatory and customer requirements.
Related standards
- ISO/ASTM 52628 - Practice for dosimetry in radiation processing (companion guidance)
- ISO 11137‑1 - Radiation sterilization of health care products (takes precedence where applicable)
- ISO 14470 - Food irradiation requirements
- ISO/IEC 17025 - Laboratory accreditation and competence
- ASTM F1355 / F1356 - Food irradiation guidance
- Additional ISO/ASTM dosimetry practices and guides (e.g., ISO/ASTM 51261, 51607, 51707)
Keywords: ISO/ASTM 51818:2020, dosimetry, electron beam, 80–300 keV, radiation processing, IQ OQ PQ, absorbed dose, depth‑dose, measurement uncertainty, traceability.
Технические детали
- Технический комитет
- ISO/TC 85 - Nuclear energy, nuclear technologies, and radiological protection
- SKU
- ISO/ASTM 51818:2020
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