標準號：BS EN ISO 17510-1-2009
中文標準名稱：睡眠窒息呼吸治療.睡眠窒息呼吸治療設備(ISO 17510-1-2007)
英文標準名稱：Sleep apnoea breathing therapy. Sleep apnoea breathing therapy equipment
標準類型：C46
發布日期：2009/4/30 12:00:00
實施日期：2009/4/30 12:00:00
中國標準分類號：C46
國際標準分類號：11.040.10
引用標準：ISO 3744-1994;ISO 32;ISO 4135-2001;ISO 4871;ISO 5356-1;ISO 5356-2;ISO 5359;ISO 8185-2007;ISO 9170-1;ISO 11135;ISO 11137;ISO 14937;ISO 14971-2007;ISO/TR 16142-2006;ISO 15223-1-2007;ISO 17510-2-2007;ISO 17664-2004;ISO 17665;ISO 23328-1;ISO 23328-2;IEC 60079
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.