GB17589-2011
Specifications for quality assurance test for computed tomography X-ray scanners
X射线计算机断层摄影装置质量保证检测规范
GB 17589-2011 is a current mandatory Chinese national standard for Specifications for quality assurance test for computed tomography X-ray scanners. It appears in the Food compliance cluster with a product safety focus and has an implementation date of May 1, 2012.
Applicability depends on product scope, certification route, competent authority notices and transition rules. Requst for the translation or verify source before using this record in a compliance decision.
Compliance overview
Scope and applicability
This standard specifies the quality assurance test methods, items, and requirements for medical X-ray computed tomography scanners (CT scanners). It is strictly applicable to the acceptance testing, status testing, and stability testing of CT machines in use. This standard is not applicable to quality control during CT machine production or to the image display and hard copy systems used alongside the scanners. It serves as a mandatory benchmark for medical imaging facilities.
Technical requirements
The standard mandates rigorous performance metrics across several critical categories. It defines the required precision for diagnostic bed positioning and positioning light accuracy, ensuring mechanical movements align with scanned cross-sections. Furthermore, it sets strict tolerances for reconstructed slice thickness deviation across various nominal thicknesses, utilizing high-contrast markers to verify spatial accuracy along the Z-axis. Regarding radiation dose and image fidelity, the standard specifies evaluation parameters for the weighted CT dose index (CTDIw) to ensure patient exposure remains within safe operational limits. It also dictates the acceptable ranges for CT number (water), image noise, and uniformity. Manufacturers and testing facilities must ensure these parameters meet the baseline values established during acceptance testing to guarantee diagnostic efficacy. Additionally, the standard outlines the criteria for high-contrast resolution and low-contrast detectability, defining the scanner's ability to resolve fine details both in high and low contrast scenarios. A newly introduced requirement in this version is the evaluation of CT number linearity, which assesses the accuracy of the CT values across different materials with varying attenuation coefficients, referencing GB/T 19042.5 for specific MTF evaluations.
Testing methods
The standard prescribes specific testing methodologies utilizing specialized phantoms and dosimeters. CTDI measurements are conducted using head (160mm diameter) and body (320mm diameter) tissue-equivalent phantoms with calibrated dose probes. Image quality metrics such as noise, uniformity, and CT number linearity are evaluated using homogeneous water phantoms and multi-material modules. Engineers must follow precise scanning protocols, including specific ROI selection and exposure conditions, to measure these parameters accurately. High-contrast resolution can be evaluated either by direct visual observation of periodic details or by calculating the modulated transfer function (MTF).
FAQs
What types of testing are regulated under GB 17589-2011?
It applies to acceptance tests, status tests, and stability tests for medical CT scanners. It does not apply to quality control during the manufacturing process or to the display and hard copy systems used with the CT scanners.
Are there any updates from the previous version of this standard?
Yes, it replaced GB/T 17589-1998. Key updates include adding CT number linearity as a new test item, modifying the definition and calculation method of noise, updating the CTDI calculation methods, and revising the testing methods for high-contrast resolution and low-contrast detectability.
How does GB 17589-2011 relate to international standards?
The standard references GB/T 19042.5 for the evaluation and routine testing of medical imaging departments. Specifically, GB 17589-2011 aligns its methods for evaluating high-contrast resolution via the modulated transfer function (MTF) with the guidelines established in GB/T 19042.5.
The summary above provides a high-level overview of GB 17589-2011. To ensure complete compliance for your medical devices entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 17589-2011 today to access all detailed parameters, tables, and testing procedures.
Applicability hints
- Type
- Health and hygiene
- CCS
- C57
- ICS
- 13.280
- Competent department
- National Health Commission
- Technical committee
- National Health Commission
Relationships
Replaces:GB/T 17589-1998