Skip to main content
Tagasi

ISO 15002:2023

Flow control devices for connection to a medical gas supply system

Üldinfo

Kehtiv alates 31.08.2023
Direktiivid või määrused
puuduvad

Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
31.08.2023
Põhitekst
03.01.2018
Muudatus
16.06.2008
Põhitekst
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); or
c)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).

Nõutud väljad on tähistatud *

*
*
*
PDF
169,14 € koos KM-ga
Paber
169,14 € koos KM-ga
Standardi monitooring

Teised on ostnud veel

Muudatus

EVS-EN ISO 18082:2014/A1:2017

Anaesthetic and respiratory equipment - Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases - Amendment 1 (ISO 18082:2014/Amd 1:2017)
Uusim versioon Kehtiv alates 18.09.2017
Põhitekst + muudatus

EVS-EN ISO 10524-1:2019+A1:2023

Meditsiiniliste gaaside rõhu regulaatorid. Osa 1: Rõhuregulaatorid ja gaasivoolu mõõteseadmega rõhuregulaatorid
Uusim versioon Kehtiv alates 15.11.2023
Põhitekst

ISO/TS 21726:2019

Biological evaluation of medical devices -- Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
Uusim versioon Kehtiv alates 01.02.2019
Põhitekst

EVS-EN ISO 1456:2009

Metallic and other inorganic coatings - Electrodeposited coatings of nickel, nickel plus chromium, copper plus nickel and of copper plus nickel plus chromium
Uusim versioon Kehtiv alates 08.10.2009