Compliance & Engineering Standards

At Oxygens we are committed to the safe design and manufacture of hyperbaric oxygen systems. Our engineering approach is guided by internationally recognised standards used within the hyperbaric and medical device industries.

Our chamber designs are being developed with reference to the following standards and safety frameworks:

• BS EN 14931 – Pressure Vessels for Human Occupancy (PVHO) — Design principles relating to structural integrity and pressure safety of hyperbaric chambers.
• NFPA 99 – Health Care Facilities Code (Chapter 14 Hyperbaric Facilities) — Guidance on fire safety, oxygen safety, and operational requirements for hyperbaric environments.
• ISO 13485 – Medical Device Quality Management Systems — Quality management systems used in the design and manufacture of medical devices.
• EU Medical Device Regulation (MDR 2017/745) — Development pathways for CE marking and regulatory approval where applicable.
• BS EN 12021 – Breathing Gas Quality — Standards governing breathable oxygen and air quality used in respiratory applications.

Oxygen System Safety — Materials, regulators, valves, and gas delivery systems are selected with reference to oxygen compatibility and safe operating practices within hyperbaric engineering.

Important Notice: Some hyperbaric systems offered by Oxygens are intended for wellness and sports recovery applications and may not be classified as medical devices in certain jurisdictions. Certification and regulatory requirements vary by country, and customers should ensure compliance with their local regulations before installation or use.