Division 1.2 Rule 2

All non-invasive devices intended for channelling or storing blood, body liquids or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in Class IIa:

• if they may be connected to an active medical device in Class IIa or a higher class,

• if they are intended for use for storing or channelling blood or other body liquids or for storing organs, parts of organs or body tissues,

in all other cases they are in Class I.