标准编号:ISO 17510:2015
中文名称:医疗设备 睡眠呼吸暂停 口罩和呼吸治疗应用配件
英文名称:Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
发布日期:2015-08
标准范围
This International Standard applies to masks and their accessories used to connect sleep apnoeabreathing therapy equipment to the patient. It specifies requirements for masks and accessories,including any connecting element, that are required to connect the patient-connection port of sleepapnoea breathing therapy equipment to a patient for the application of sleep apnoea breathingtherapy (e.g. nasal masks, exhaust ports and headgear).Sleep apnoea breathing therapy equipment is covered by ISO 80601-2-70. Figure A.1 shows thetypical elements of this International Standard together with the sleep apnoea breathing therapyequipment of ISO 80601-2-70 that form a sleep apnoea breathing system.This International Standard does not cover oral appliances.