USA/1228
WTO/TBT
US Vereinigte Staaten von Amerika
  • 13 - Umwelt, Gesundheitsschutz, Sicherheit
  • 23 - Fluidsysteme und -bauteile
N/A
2016-11-28

Medical gas containers and closures. Medical equipment (ICS: 11.040), Fluid storage devices (ICS: 23.020)

Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements (13 pages, in English)

The Food and Drug Administration (FDA or the Agency) is
amending its current good manufacturing practice (CGMP) and labeling regulations
regarding medical gases. FDA is requiring that portable cryogenic medical gas containers
not manufactured with permanent gas use outlet connections have gas-specific use outlet
connections that cannot be readily removed or replaced except by the manufacturer. FDA
is also requiring that portable cryogenic medical gas containers and high-pressure medical
gas cylinders meet certain labeling, naming, and color requirements. These requirements
are intended to increase the likelihood that the contents of medical gas containers are
accurately identified and reduce the likelihood of the wrong gas being connected to a gas
supply system or container. FDA is also revising an existing regulation that conditionally
exempts certain medical gases from certain otherwise-applicable labelling requirements in
order to add oxygen and nitrogen to the list of gases subject to the exemption, and to
remove cyclopropane and ethylene from the list.