Hydrogen Tech World June 2025 | Page 41

[ oxygen ]

Low pressure alkaline water electrolysis process

Regenerative twin bed dryer for hydrogen purification

O 2

High voltage electricity

H 2

Phase separator

Scrubber Cooler

Filter

Alkaline electrolysis stack

Filter

Lye recycle

Lye recycle

KOH management

Lye tank

N 2

Fresh KOH

© 2025 sbh4 GmbH

Certified medical devices

Hospitals can also produce oxygen on-site using PSA or VSA equipment. The OXYPLUS range from Novair Medical in France and the ULTRAOX ® equipment from Ultra Controlo in Portugal are examples of this type of equipment. for regulatory purposes. It covers the entire lifecycle of a medical device, including design, development, production, installation, and servicing. It helps organisations ensure their products meet both customer and regulatory requirements for safety and efficacy.

CSF Engineering, a German industrial gases equipment producer, also offers medicinal oxygen PSA systems. Furthermore, the Danish company OXYMAT produces medicinal oxygen PSA equipment in Slovakia.

Extrapolating current rules to the potential use of electrolysers to generate oxygen in situ at a hospital, the equipment would need to be manufactured in accordance with ISO13485:2016 and certified as a medical device.

PSA and VSA medicinal oxygen concentrators are certified medical devices, and the oxygen concentration, carbon monoxide, carbon dioxide, and moisture impurities must be continuously measured.

ISO13485:2016 applies to Medical devices – Quality management systems – Requirements

Offsite medicinal oxygen production requires a marketing authorisation

Cryogenic air separation units( ASUs) used in the industrial gases sector produce oxygen that can be allocated for medical applications. The EU Oxygen Monograph( 01 / 2010:0417) stipulates that medicinal oxygen produced in cryogenic ASUs must have a purity of 99.5 % by volume or higher.

Hydrogen Tech World | Issue 22 | June 2025 41