GB16348-2010
Radiological protection standards for the examinee in medical X-ray diagnosis
医用X射线诊断受检者放射卫生防护标准
GB 16348-2010 is a current mandatory Chinese national standard for Radiological protection standards for the examinee in medical X-ray diagnosis. It appears in the Food compliance cluster with a product safety focus and has an implementation date of Jun 1, 2011.
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 protection principles and basic requirements for examinees undergoing medical X-ray diagnostic procedures, including special requirements for children, women of childbearing age, and pregnant women. It applies to medical X-ray diagnostic examinations in healthcare facilities. It is mandatory for all medical institutions conducting X-ray diagnostics in China. It does not apply to industrial or non-medical X-ray applications. The standard references GB 18871-2002 and GBZ 130 for foundational safety requirements.
Technical requirements
The standard mandates justification for all X-ray examinations, requiring physicians to evaluate clinical necessity and prioritize non-X-ray alternatives. Unnecessary repeated examinations must be strictly avoided. It emphasizes the optimization of protection, ensuring patient doses are kept as low as reasonably achievable (ALARA). Facilities must use qualified diagnostic X-ray equipment, protective devices, and establish a quality assurance program to prevent equipment failure and human error. For pediatric X-ray examinations, the standard requires specialized protective equipment with a shielding performance of no less than 0.5mm lead equivalent. Equipment must feature image intensifiers and automatic brightness/dose control. Children should not be used as teaching or research cases without special permission. Shielding of non-examined areas, particularly the gonads and eye lenses, is strictly required. For women of childbearing age, abdominal or pelvic X-rays should ideally be limited to the 10 days following the onset of menstruation. Strict limitations are placed on mass X-ray screenings, such as intrauterine device checks or mammography. Mammography for women under 20 should be approached with extreme caution. For pregnant women, X-ray examinations require informed consent and a signature from the patient or immediate family. Abdominal X-rays during early pregnancy (especially weeks 8-15) are prohibited unless absolutely necessary. Routine chest X-rays before delivery and pelvic measurements are generally not permitted.
Testing methods
The standard requires quality control testing for all X-ray diagnostic equipment, including acceptance, status, and stability testing, before clinical use. It also provides dose guidance levels (Appendix B) for typical adult examinees across various modalities, including radiography, CT, mammography, and fluoroscopy. These levels serve as reference values to ensure patient exposure remains within acceptable limits.
FAQs
What products and facilities are regulated under GB 16348-2010?
GB 16348-2010 regulates medical X-ray diagnostic equipment and the facilities operating them. It applies to all healthcare institutions performing X-ray examinations on patients, with specific mandates for protecting children, women of childbearing age, and pregnant women.
Are there any updates from the previous version of GB 16348-2010?
Yes, GB 16348-2010 replaces GB 16348-1996, GB 16349-1996, and GB 16350-1996. It integrates these standards and introduces requirements for quality assurance programs, equipment quality control testing, and explicit informed consent protocols for pregnant women.
Does GB 16348-2010 specify dose limits for patients?
Instead of strict dose limits, the standard provides dose guidance levels for typical adult examinees in Appendix B. These cover radiography, CT, mammography, and fluoroscopy, serving as benchmarks to ensure optimization of protection (ALARA principle) rather than absolute regulatory limits.
The summary above provides a high-level overview of GB 16348-2010. To ensure complete compliance for your medical devices and facilities entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 16348-2010 today to access all detailed parameters, dose guidance 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 16349-1996, GB 16350-1996, GB 16348-1996