DS/EN ISO 15002:2008

Flow-metering devices for connection to terminal units of medical gas pipeline systems


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 74.53
Legislation:

Legislation

Harmonized under:
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:
Links

Scope

1.1 This International Standard is applicable to:
– flow-metering devices that are connected, either directly or by means of flexible connecting assemblies, and disconnected by the operator at terminal units of a medical gas pipeline system for flow adjustment, measurement and delivery of medical gases;
– flow-metering devices that are connected and disconnected by the operator at gas-specific connection points of devices such as pressure regulators.
1.2 This International Standard applies to:
a) flow-metering devices intended to be used with the following medical gases:
– oxygen;
– nitrous oxide;
– medical air;
– carbon dioxide;
– oxygen/nitrous oxide mixture [50 %/50 % (by volume)];
– specified mixtures of the gases listed above;
b) flow-metering devices intended to be used with the following gases:
– oxygen-enriched air;
– helium;
– xenon.
NOTE – Regional or national regulations might permit use of oxygen-specific connection points for oxygen-enriched air.
1.3 This International Standard does not apply to electrical or electronic flow-metering devices.
1.4 This International Standard does not apply to gases used for driving surgical tools.


Number of pages: 40

Published: 2008-10-23

Date of approval: 2008-09-19

International relationships : EN ISO 15002:2008 IDT ISO 15002:2008 IDT

ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment

Item number: M207200


Committees

Committee

  • CEN/TC 215
  • ISO/TC 121/SC 6

Danish committee

DS/S-104