GB/T 19042.2-2025 Pending National standards

GB/T 19042.2-2025 Evaluation and routine testing in medical imaging departments—Part 3-2:Mammographic X-ray equipment imaging performance acceptance tests

Publish Date: 2025-08-01 Implement Date: 2026-08-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 19042.2-2025

Standard Type: National standards

Standard Status: Pending

is_force_gb: no

CCS Name: Medical radiation equipment

ICS Name: X-ray imaging equipment

Publish Date: 2025-08-01

Implement Date: 2026-08-01

Pages: 56 pages

Scope

This document is applicable to the evaluation of the effectiveness of breast X-ray equipment in terms of image quality and dose, and also covers aspects of equipment safety.
This document is applicable to breast X-ray equipment (hereinafter referred to as "breast X-ray equipment") and breast X-ray stereotactic positioning devices.
When the X-ray image receiver is not an integral part of the breast X-ray equipment, the tests described in this document must ensure the quality and performance of the X-ray image receiver before the acceptance test, including X-ray photographic film (hereinafter referred to as "film"), intensifying screens, X-ray photographic cassettes (hereinafter referred to as "cassettes"), storage phosphor plates (hereinafter referred to as "IP plates") and ancillary equipment, such as film processors or storage phosphor plate readers (hereinafter referred to as "CR"), image display devices and hardcopy cameras.
Note: For descriptions of IP plates and CR, see YY/T 0794-2022, Sections 3.2 and 3.1.
The tests involving cassettes and intensifying screens in this document are described in ISO 4090, and the sensitivity and contrast tests involving screen-film image receivers are described in ISO 9236-3.
The measurements described in this document can provide data for calculating the average glandular dose.
When the results of the acceptance test meet the expected values, these values can be used as a reference value for subsequent stability tests.
This document defines:
a) the basic parameters of the performance of the aforementioned breast X-ray equipment in terms of image quality and dose; and
b) the methods for detecting whether the measurement results related to these parameters comply with the specified deviations.
These methods are primarily based on non-invasive measurements using appropriate test equipment and are conducted during or after installation. During installat