ISO 21647:2004 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

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

ISO 21647:2004规定了呼吸气体监测仪（RGM）（定义见3.15）的基本安全和基本性能的特殊要求，该监测仪用于与人类一起使用的连续操作。它补充了IEC 60601-1:1988的要求。ISO 21647:2004规定了麻醉气体监测、二氧化碳监测和氧气监测的要求。ISO 21647:2004不适用于与易燃麻醉剂一起使用的监测器。替代或修改IEC 60601要求的ISO 21647:2004要求-1:1988及其修正案1（1991）和2（1995）旨在优先于相应的一般要求。附件CC阐述了环境方面的问题。ISO 14971中阐述了环境影响的其他方面。

ISO 21647:2004 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. It supplements the requirements of IEC 60601-1:1988.ISO 21647:2004 specifies requirements for anaesthetic gas monitoring, carbon dioxide monitoring and oxygen monitoring.ISO 21647:2004 is not applicable to monitors intended for use with flammable anaesthetic agents.The requirements of ISO 21647:2004 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. Additional aspects of environmental impact are addressed in ISO 14971.

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