標(biāo)準(zhǔn)號(hào)：ISO 17510-1-2007
中文標(biāo)準(zhǔn)名稱(chēng)：睡眠窒息呼吸治療.第1部分:睡眠窒息呼吸治療設(shè)備
英文標(biāo)準(zhǔn)名稱(chēng)：Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment
標(biāo)準(zhǔn)類(lèi)型：C46
發(fā)布日期：2007/10/1 12:00:00
實(shí)施日期：1999/12/31 12:00:00
中國(guó)標(biāo)準(zhǔn)分類(lèi)號(hào)：C46
國(guó)際標(biāo)準(zhǔn)分類(lèi)號(hào)：11.040.10
適用范圍：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.