ISO 9919-2005 医用电气设备.医用脉动式血氧计的基本安全和性能的特殊要求.pdf

标准号：ISO 9919-2005
实施状态：作废
中文名称：医用电气设备.医用脉动式血氧计的基本安全和性能的特殊要求
英文名称：Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
发布日期：2005-03
被替代标准：ISO 80601-2-61-2011
代替标准：ISO 9919-1992;ISO/FDIS 9919-2004
采用标准：DIN EN ISO 9919-2005,IDT;DIN EN ISO 9919-2009,IDT;ANSI/ASTM/ISO 9919-2009,IDT;BS EN ISO 9919-2005,IDT;BS EN ISO 9919-2009,IDT;EN ISO 9919-2005,IDT;EN ISO 9919-2009,IDT;prEN ISO 9919-2008,IDT;NF S95-158-2005,IDT;NF S95-158-2009,IDT;S95-158PR,IDT;CAN/CSA-Z9919-07-2007,IDT;SN EN ISO 9919-2005,IDT;SN EN ISO 9919-2009,IDT;OENORM EN ISO 9919-2005,IDT;OENORM EN ISO 9919-2009,IDT;OENORM EN ISO 9919-2009,IDTN-EN ISO 9919-2005,IDTN-EN ISO 9919-2009,IDT;UNE-EN ISO 9919-2006,IDT;UNE-EN ISO 9919-2009,IDT;GOST R ISO 9919-2007,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 1.1):
This International Standard specifies particular requirements for the basic safety and essential performance of
pulse oximeter equipment intended for use on humans. This includes any part necessary for normal use,
e.g. the pulse oximeter monitor, pulse oximeter probe, probe cable extender.
These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse
oximeter probes and probe cable extenders, that has been reprocessed.
The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial
oxygen haemoglobin saturation and pulse rate on patients in healthcare institutions as well as on patients in
home care.
* This International Standard is not applicable to pulse oximeter equipment intended for use in laboratory
research applications nor to oximeters that requires a blood sample from the patient.
This International Standard is not applicable to pulse oximeter equipment solely intended for foetal use.
This International Standard is not applicable to remote or slave (secondary) devices that display SpO2 values
that are located outside of the patient environment.
The requirements of this International Standard which replace or modify requirements of IEC 60601-1:1988
and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general
requirements.
文件格式：PDF
文件大小：1.22MB
文件页数：92
（以上信息更新时间为：2019-11-22）



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