市场监管总局批准发布首个《婴儿光治疗设备校准规范》

市场监管总局批准发布了首个《婴儿光治疗设备校准规范》1，该规范明确了婴儿光治疗设备的计量特性、校准条件、校准项目以及校准方法和结果表达1。这一规范为新生儿黄疸的光疗治疗提供了统一的技术标准。

我国每年约有800万新生儿出生，其中约60%的足月儿和80%的早产儿会出现不同程度的黄疸1。光疗是治疗新生儿黄疸最普遍的手段，设备通过发射特定波长的蓝光，将胆红素转化为水溶性异构体，使其排出体外1。新规范的发布将保障光照治疗的安全性和有效性。

China's State Administration for Market Regulation has approved and released the first calibration standard for infant phototherapy equipment 1. The new standard establishes metrological characteristics, calibration conditions, items, and methodologies for devices used in neonatal jaundice treatment, creating a unified framework for phototherapy safety and efficacy 1.

Approximately 8 million newborns are born in China annually, with about 60% of full-term infants and 80% of premature infants experiencing jaundice to varying degrees 1. Phototherapy represents the most common treatment approach for this condition, utilizing devices that emit specific wavelengths of blue light to convert bilirubin into water-soluble isomers that can be excreted from the body 1. The standard specifies calibration conditions, calibration items, methodologies, and formats for expressing results 1, ensuring consistent and reliable treatment across medical facilities.