Standard Number: YY 9706.269-2021(YY9706.269-2021)
Chinese:医用电气设备 第2-69部分：氧气浓缩器的基本安全和基本性能专用要求
English:Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator euipment
Effective Date:2023-05-01
ICS:11.040.10
Standard Applicability:This standard establishes basic safety and basic performance-specific requirements for oxygen concentrators and their accessories, which are intended to be used to increase the concentration of gaseous oxygen delivered to a single patient. Such oxygen concentrators are typically used in the home care setting, including in any environment including private transportation, public transportation, and commercial aircraft that is operable on transfer and used by a single patient. This standard applies to both transfer-capable and non-transfer-capable oxygen concentrators. This standard applies to oxygen concentrators that are integrated into or used with other medical devices, medical electrical equipment, or medical electrical systems. (e.g., oxygen concentrators with oxygen economizers or humidifiers; oxygen concentrators used with separate flowmeters; oxygen concentrators used on anesthesia systems used in areas of limited electrical power and logistical supply of anesthetic gases; oxygen concentrators with liquid oxygen tanks or cylinder filling systems.) This standard also applies to accessories that are expected to be connected to oxygen concentrators and whose characteristics affect the basic safety and essential performance of the oxygen concentrator. This standard does not specify requirements for oxygen concentrators used in medical gas piping systems.
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