Standard Number: YY 9706.250-2021(YY9706.250-2021)
Chinese:医用电气设备 第2-50部分:婴儿光治疗设备的基本安全和基本性能专用要求
English:Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
Effective Date:2023-05-01
ICS:11.040.60
Standard Applicability:This standard establishes safety requirements for infant phototherapy devices. However, if the manufacturer has demonstrated in its risk management documentation that the risk of harm can be maintained within acceptable limits when compared to the benefits of treatment with the device, an alternative method that meets the specified provisions and has an equivalent level of safety will not be considered to be in violation of the relevant provisions. This standard applies to the basic safety and basic performance of infant phototherapy devices. This standard does not apply to: devices that provide heat through blankets, pads or mattresses in medical use; infant incubators; infant transfer incubators; and infant radiant warming tables.
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