SR EN ISO 15002:2024

Flow control devices for connection to a medical gas supply system (ISO 15002:2023)

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;

36.31 €

Status : Valid
Approval date : 9/30/2024
Number of pages : 34
ICS : 11.040.10 Anaesthetic, respiratory and reanimation equipment
Technical Committee : 377 - Medical devices

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