医疗器械 — 睡眠呼吸暂停治疗 — 面罩和应用附件

[中文适用范围]： 本文件规定了用于将睡眠呼吸暂停呼吸治疗设备的患者连接端口连接到患者的面罩及其配件（包括任何连接部件）的要求，适用于睡眠呼吸暂停呼吸治疗（例如鼻面罩、排气口和头带）。本文件适用于将睡眠呼吸暂停呼吸治疗设备连接到患者的面罩及其配件。本文件中的要求优先于ISO 18190中的要求。本文件不涵盖口腔矫治器。注：本文件的编制旨在应对附件I中所列国际医疗器械监管机构论坛（IMDRF）的相关基本原则[14]和标签原则[15]。 [外文原描述]： This document specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear). This document applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient. The requirements in this document take priority over the requirements in ISO 18190. This document does not cover oral appliances. NOTE This document has been prepared to address the relevant essential principles [14] and labelling principles [15] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex I.