GB10152-2009
B mode ultrasonic diagnostic equipment
B型超声诊断设备
GB 10152-2009 is a current mandatory Chinese national standard for B mode ultrasonic diagnostic equipment. It appears in the Electronics compliance cluster with a product safety focus and has an implementation date of Dec 1, 2010.
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 applies to B-mode ultrasonic diagnostic equipment (including the 2D grayscale imaging portion of color Doppler ultrasound equipment) with a nominal frequency ranging from 1.5MHz to 15MHz. It is strictly not applicable to ophthalmic specialized ultrasound diagnostic equipment or intravascular ultrasound diagnostic equipment. Manufacturers of general medical ultrasound devices targeting the Chinese market must verify compliance with this mandatory national standard.
Technical requirements
This standard specifies comprehensive mandatory technical and safety requirements for B-mode ultrasound equipment. The safety requirements mandate compliance with GB 9706.1 for general safety and GB 9706.9 for specific ultrasonic equipment safety. Manufacturers must ensure their devices meet these baseline electrical and mechanical safety criteria before market entry. Regarding performance, the standard defines critical imaging parameters including penetration depth, axial resolution, lateral resolution, and dead zone. These parameters are categorized by probe type and nominal frequency, establishing the minimum acceptable performance thresholds. Manufacturers may publish stricter performance metrics in their accompanying documentation, but they must never fall below the standard's baseline limits. Additionally, the standard introduces requirements for slice thickness, geometric position precision (both lateral and longitudinal), and measurement deviations for perimeter and area. For advanced features, M-mode time display error and 3D reconstruction volume calculation deviation are also regulated. The equipment must also withstand voltage variations of ±10% and support continuous operation for over 8 hours.
Testing methods
Testing must be conducted using specified tissue-mimicking phantoms and devices compliant with YY/T 1142 and YY/T 0108. The standard outlines procedures for measuring acoustic working frequency, evaluating imaging resolution at specific depths, and verifying geometric measurement accuracy. Manufacturers are required to document and publish the exact B-scan settings used during testing, such as focus, gain, and TGC, to ensure reproducibility. Environmental testing procedures must also be executed in accordance with GB/T 14710.
FAQs
What products are regulated under GB 10152-2009?
The standard applies to B-mode ultrasonic diagnostic equipment with a nominal frequency in the range of 1.5MHz to 15MHz, including the 2D grayscale imaging portion of color Doppler ultrasound equipment. It does not apply to ophthalmic specialized ultrasound or intravascular ultrasound diagnostic equipment.
Are there any major updates from the previous version of GB 10152?
The updated version added five new technical indicators: slice thickness, perimeter and area measurement deviation, M-mode time display error, 3D reconstruction volume calculation deviation, and functional use requirements. It also aligned the safety requirements with the general standard GB 9706.1 and removed the previous classification appendix.
How does GB 10152-2009 relate to international IEC standards?
The safety requirements in GB 10152-2009 are fully aligned with the Chinese national medical electrical equipment standards, which are identical (idt) to the corresponding IEC standards, such as IEC 60601-1 for general safety and IEC 60601-2-37 for ultrasonic diagnostic equipment.
The summary above provides a high-level overview of GB 10152-2009. 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 10152-2009 today to access all detailed parameter tables, testing procedures, and equipment setup guidelines.
Applicability hints
- Type
- Safety
- CCS
- C41
- ICS
- 11.040.50, 11.040.55
- Competent department
- National Medical Products Administration
- Technical committee
- National Technical Committee on Medical Electrical Equipment of Standardization Administration of China
Relationships
Replaces:GB 10152-1997