New Standard Improves Safety of Infant Phototherapy Equipment

China's State Administration for Market Regulation (SAMR) has approved the first national standard for the calibration of phototherapy equipment used for infants. This new regulation, titled "Calibration Specification for Infant Phototherapy Equipment," establishes a unified "measuring stick" for quality control of devices treating neonatal jaundice, aiming to make phototherapy safer, more precise, and effective for millions of newborns.

Neonatal jaundice is a common condition, affecting an estimated 60% of full-term and 80% of premature infants born in China annually. If untreated or inadequately managed, severe hyperbilirubinemia can lead to irreversible neurological damage or be life-threatening. Phototherapy is the primary treatment method, utilizing specific wavelengths of blue light to convert excess bilirubin into a water-soluble isomer for excretion.

The efficacy of phototherapy relies heavily on the accuracy of the equipment's radiant intensity and the uniformity of the light exposure. Significant deviations in these parameters can not only reduce treatment effectiveness but also potentially cause harm to an infant's skin and eyes.

The newly released calibration specification defines the metrological characteristics of infant phototherapy equipment and stipulates calibration conditions, items, methods, and result expressions. It provides technical guidance to improve product quality, ensuring infants receive safer and more effective treatment.