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GB/T 40590-2021Specification for operation and maintenance management of electron accelerator facility for radiation processing (English PDF)

辐射加工用电子加速器装置运行维护管理通用规范

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

October 11, 2021

Implementation date

May 1, 2022

Scope

GB/T 40590-2021 is the English-translated version of 辐射加工用电子加速器装置运行维护管理通用规范.

GB/T 40590-2021 sets management and quality control requirements for operating and maintaining electron accelerator facilities used for radiation processing. It applies to facilities with an electron beam energy of 0.3 MeV to 10 MeV and an X-ray energy of not more than 5 MeV, and facilities with a beam energy below 300 keV may use it for reference.

After defining terms such as electron accelerator facility, operating unit, installation qualification and operational qualification, it gives general requirements followed by clauses on operation management, maintenance management, and radiation protection emergency management and accident handling.

It relies on dosimetry, radiation sterilization and radiation protection standards including GB/T 16841, GB 18280, GB 18871, GB/T 25306 and HJ 979. It was issued on 11 October 2021 and has applied since 1 May 2022.

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Document preview — GB/T 40590-2021

National Standard of the People's Republic of China

ICS: 27.120
Classification: F 90

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Operation Management
6 Operation Management
7 Maintenance and management
8 Radiation protection emergency management and accident handling

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" Drafting.

1 Scope

This document specifies the management and quality control requirements for the operation, operation, and maintenance of electron accelerator devices for radiation processing.

This document is suitable for radiation processing where the electron beam energy is 0.3MeV~10MeV and the X-ray energy is not more than 5MeV Electron accelerator device. The electron accelerator device for radiation processing with electron beam energy lower than 300keV can be implemented by reference.

2 Normative references

The content of the following documents constitutes an indispensable clause of this document through normative references in the text. Among them, dated quotations Only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 16841-2008 Energy of 300keV~25MeV electron beam radiation processing device dosimetry guide

GB 18280.1-2015 Radiation for sterilization of medical and health care products Part 1: Development, validation and routine of the sterilization process of medical devices Control requirements

GB 18280.2 Sterilization Radiation of Medical and Health Care Products Part 2: Establishing the Sterilization Dosage

GB 18871 Basic Standards for Ionizing Radiation Protection and Radiation Source Safety

GB/T 25306-2010 General Specification for Electron Accelerator Engineering for Radiation Processing

HJ979-2018 Radiation Safety and Protection of Electron Accelerator Irradiation Device

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Electron accelerator facility

A device that generates, accelerates, and draws electron beams for radiation processing. [Source: GB/T 25306-2010, 3.3, with modification]

3.2 Operating unit

Units qualified and capable of undertaking the operation of accelerator irradiation devices.

3.3 Installation qualification; IQ

The process of obtaining evidence and documenting it to prove that the equipment has been provided and installed in accordance with the technical specifications. [Source: GB 18280.1-2015, 3.16]

3.4 Operational qualification; OQ

The process of obtaining evidence and documenting it to prove that when the equipment is used in accordance with the equipment operating procedures, the installed equipment is within the predetermined range […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

GB/T 11813-2026|GB/T 15476-2026|GB/T 43257.8-2026|GB/T 11843-2025|GB/T 11926-2025|GB/T 11927-2025

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