标准编号:ISO 17510-1:2007

中文名称:睡眠窒息呼吸疗法 第1部分:睡眠窒息呼吸治疗设备

英文名称:Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy equipment

发布日期:2007-10

标准范围

IEC 60601-1:1988, Clause 1 applies, except as follows.Amendment (add at the end of the Subclause 1.1):This part of ISO 17510 specifies requirements for equipment intended for sleep apnoea breathing therapy fordomiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions.This part of ISO 17510 applies to equipment intended for use with adults and children, and excludesequipment intended for use with neonates.Jet and very high frequency ventilation and oscillation are not considered in this part of ISO 17510.This part of ISO 17510 does not apply to equipment covered by the scope of the ISO 10651 series, including:? ISO 10651-2:2004;? ISO 10651-3:1997;? ISO 10651-4:2002;? ISO 10651-5:2006;? ISO 10651-6:2004.This part of ISO 17510 does not apply to equipment covered by the scope of IEC 60601-2-12.ISO 17510 covers sleep apnoea breathing therapy equipment for patient use. ISO 17510-2 applies to masksand accessories used to connect sleep apnoea breathing therapy equipment to the patient. See alsoFigure AA.1.

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