Doc. 195/15 Safe Design and Operation of On Site Generation of Oxygen 93% for Medical Use

Oxygen for medicinal use is a prime requirement for all healthcare facilities for both the treatment of patients with respiratory disease and for providing additional oxygen to patients being treated within the facility.

The design requirements for the supply source used to supply medical oxygen to the pipeline system are detailed in the standard, EN ISO 7396-1 Medical gas pipeline systems; Pipeline systems for compressed medical gases and vacuum. Two different products are included in the standard:

  • Medicinal oxygen supplied from liquid oxygen vessels and/or gaseous oxygen cylinders; and
  • Oxygen 93 manufactured on-site within the healthcare facility, using an oxygen concentrator unit.

Oxygen 93 can be manufactured on-site within the healthcare facility, under the responsibility of the healthcare facility pharmacist, using an oxygen 93 supply system and meeting the appropriate and specific quality and safety criteria for medicinal products prepared in Pharmacies.

 

Oxygen 93 concentrator units are covered by the requirements for CE marking in accordance with the Medical Device Regulation.

This publication provides guidance for the safe design, installation, operations, maintenance and quality management of oxygen 93 concentrators systems used in healthcare facilities.

It is intended for use by EIGA Members, healthcare facility managers and responsible pharmacists, oxygen concentrators’ manufacturers; and national regulatory authorities involved in the regulation and inspection of the manufacturing and administration of gases for medicinal use.

This revision of the document includes general changes and the impact of the Medical Device Regulation.