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60.60 Standard published Mar 16, 2016
CEN
CEN/TC 215 Respiratory and anaesthetic equipment
European Norm
11.040.10 Anaesthetic, respiratory and reanimation equipment
Published
ISO 5360:2016 specifies requirements, including dimensions, for agent-specific filling systems for agent-specific anaesthetic vaporizers.
ISO 5360:2016 does not specify construction materials.
NOTE 1 For recommendations on materials, see Annex A.
Because of the unique properties of desflurane, dimensions for this agent have not been specified in this International Standard.
NOTE 2 Designs of connection systems, which only permit engagement of the agent-specific bottle adaptor to the bottle when the bottle collar is in place, are encouraged.
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
WITHDRAWN
EN ISO 5360:2012
PUBLISHED
EN ISO 5360:2016
60.60
Standard published
Mar 16, 2016