ISO 15002:2023 连接医用供气系统的流量控制装置

标准编号：ISO 15002:2023

中文名称：连接医用供气系统的流量控制装置

英文名称：Flow control devices for connection to a medical gas supply system

发布日期：2023-08

标准范围

本文件规定了流量控制装置的要求，用户可以通过探头或气体专用连接器直接连接，或者通过符合ISO 5359的低压软管组件间接连接到:A）？符合ISO 9170-1标准的医用气体管道系统的终端单元？7396-1:2016;b）？符合ISO 10524-1:20 18的调节器的压力出口；或c）？符合ISO 10524-3的阀门集成压力调节器（VIPR）的压力出口（参见5.2气体入口）。本文件适用于以下类型的流量控制装置（FCD）:A）？流量计；b）？流量计FCD；和c）？固定孔FCD。笔记？被归类为医用电气设备的流量控制装置可遵守IEC 60601-的附加要求。1.本文件适用于以下气体的流量控制装置:—？氧气；—？氧气93？%;—？一氧化二氮；—？医用空气；—？二氧化碳；—？氧气/一氧化二氮混合物50/50(%体积分数)；—？富氧空气；—？氦；—？氙；和—？上述气体的特定混合物。注:流量控制装置可用于其他气体。本文件不适用于以下流量控制装置:A）？与用于驱动手术工具的气体一起使用；b）？调节器的组成部分（参见ISO 10524-1:20 18）；或c）？集成压力调节器（VIPR）阀门的组成部分（参见ISO 10524-3）。

This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:

a)    a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;

b)    the pressure outlet of a regulator conforming with ISO 10524-1:2018; or

c)    to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).

This document applies to the following types of flow control devices (FCDs):

a)    flowmeters;

b)    flowgauge FCDs; and

c)    fixed orifice FCDs.

NOTE       Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.

This document applies to flow control devices for the following gases:

—    oxygen;

—    oxygen 93 %;

—    nitrous oxide;

—    medical air;

—    carbon dioxide;

—    oxygen/nitrous oxide mixture 50/50 (% volume fraction);

—    oxygen-enriched air;

—    helium;

—    xenon; and

—    specified mixtures of the gases listed above.

NOTE Flow control devices can be available for other gases.

This document does not apply to flow control devices that are:

a)    for use with gases for driving surgical tools;

b)    an integral part of a regulator (see ISO 10524-1:2018); orc)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).

标准预览图