标准号:ISO 17510-1-2007
实施状态:作废
中文名称:睡眠窒息呼吸治疗.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:2007-10-01
被替代标准:ISO 80601-2-70-2015
代替标准:ISO 17510-1-2002;ISO/FDIS 17510-1-2007
采用标准:DIN EN ISO 17510-1-2008,IDT;DIN EN ISO 17510-1-2009,IDT;DIN EN ISO 17510-1-2006,IDT;08/30192505 DC-2008,IDT;BS EN ISO 17510-1-2007,IDT;BS EN ISO 17510-1-2009,IDT;EN ISO 17510-1-2007,IDT;EN ISO 17510-1-2009,IDT;prEN ISO 17510-1-2008,IDT;NF S95-182-1-2007,IDT;NF S95-182-1-2009,IDT;S95-182-1PR,IDT;CAN/CSA-Z17510-1-10-2010,NEQ;SN EN ISO 17510-1-2007,IDT;SN EN ISO 17510-1-2009,IDT;OENORM EN ISO 17510-1-2008,IDT;OENORM EN ISO 17510-1-2009,IDT;OENORM EN ISO 17510-1-2008,IDT
N-EN ISO 17510-1-2007,IDT
N-EN ISO 17510-1-2009,IDT;UNE-EN ISO 17510-1-2008,IDT;UNE-EN ISO 17510-1-2009,IDT
起草单位:ISO/TC 121
标准简介: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 for
domiciliary 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 excludes
equipment 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 masks
and accessories used to connect sleep apnoea breathing therapy equipment to the patient. See also
Figure AA.1.
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(以上信息更新时间为:2019-11-22)
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