ISO 8835-4:2004 吸入式麻醉系统 第4部分：麻醉剂蒸汽传递装置

标准编号：ISO 8835-4:2004

中文名称：吸入式麻醉系统 第4部分：麻醉剂蒸汽传递装置

英文名称：Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices

发布日期：2004-06

标准范围

就ISO 8835-4:20 04而言，IEC 60601-1:19 88第1条中的要求适用，但以下情况除外。添加:ISO 8835-4:20 04规定了麻醉蒸汽输送装置（AVDD）基本性能的特殊要求，如3.1中所定义。ISO 8835-4:20 04适用于AVDD，该AVDD是麻醉系统的组成部分，旨在由操作员持续护理。ISO 8835-4:20 04给出了AVDD的具体要求，这些要求是对IEC 60601-2-13中适用的一般要求的补充。ISO 8835-4:20 04不适用于附录CC确定的用于易燃麻醉剂的AVDD，以及用于麻醉呼吸系统（例如吸入式蒸发器）的AVDD。取代或修改IEC 60601-1:19 88及其修正案1（1991）和2（1995）要求的ISO 8835-4:20 04要求旨在优先于相应的一般要求。

For the purposes of ISO 8835-4:2004, the requirements in IEC 60601-1:1988, Clause 1 apply except as follows.Addition:ISO 8835-4:2004 specifies particular requirements for the essential performance of anaesthetic vapour delivery devices (AVDDs), as defined in 3.1. ISO 8835-4:2004 is applicable to AVDDs which are a component of an anaesthetic system and are intended to be continuously operator-attended. ISO 8835-4:2004 gives specific requirements for AVDDs which are supplementary to the applicable general requirements in IEC 60601-2-13.ISO 8835-4:2004 is not applicable to AVDDs intended for use with flammable anaesthetics, as determined by Annex CC, and AVDDs intended for use within anaesthetic breathing systems (e.g. draw-over vaporizers).The requirements of ISO 8835-4:2004 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.

标准预览图