Standard Number: YY/T 0671-2021(YY/T0671-2021)
Chinese:医疗器械 睡眠呼吸暂停治疗 面罩和应用附件
English:Medical devices – Sleep apnoea breathing therapy – Masks and application accessories
Effective Date:2024-05-01
ICS:11.040.10
Standard Applicability:This standard applies to masks and their accessories that connect sleep apnea therapy devices to patients. This standard details the requirements for masks and accessories, including any connectors (e.g., nasal masks, venting ports, and headbands) required to connect the patient connection port on sleep apnea therapy equipment to a patient undergoing sleep apnea therapy. The requirements for sleep apnea treatment equipment are described in Standard YY 9706.270 (ISO 80601-2-70). This standard and YY 9706.270 (ISO 80601-2-70) form two parts of a sleep apnea treatment system. This standard does not include requirements for oral appliances.
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