90.93 Standard confirmed Mar 15, 2022
CEN
CEN/TC 215 Respiratory and anaesthetic equipment
European Norm
11.040.10 Anaesthetic, respiratory and reanimation equipment
This part of EN 13544 specifies requirements for tubing to be used with equipment for the therapeutic administration of respirable gases in domiciliary, ambulance and hospital practice including the interface to the equipment i.e. nipples and screw threaded connectors. This tubing is mainly used with oxygen, air or mixtures of these gases.
The interface specifications are given to ensure interchangeability of respiratory therapy equipment thereby enabling patients to receive continuous treatment in all these clinical situations.
Weight-bearing screw-threaded connectors are specified for use at the outlet of e.g. flowmeters to which devices such as humidifiers or nebulizers can be attached.
NOTE This standard does not specify the devices where these connectors have to be used. It is expected that specific device standards will specify the devices where these connectors are going to the used e.g. EN ISO 10651 4, EN 738-1 and EN 13220.
Legislation related to this standard
Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
PUBLISHED
EN 13544-2:2002+A1:2009
90.93
Standard confirmed
Mar 15, 2022