标准编号：ISO 21647:2004
中文名称：医用电子装备 呼吸器官气体检测器基本安全和必备性能的特别发求
英文名称：Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors
发布日期：2004-11
标准范围
IEC 60601-1:1998, 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 respiratory gas monitors (RGM) (as defined in 3.15) intended for continuous operation for use with humans. This International Standard specifies requirements for aa) anaesthetic gas monitoring, bb) carbon dioxide monitoring, cc) oxygen monitoring. This International Standard is not applicable to monitors intended for use with flammable anaesthetic agents. The requirements of this International Standard which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements. Environmental aspects are addressed in Annex CC. NOTE Additional aspects of environmental impact are addressed in ISO 14971.
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