Hyperbaric Chamber Certifications and Safety Standards

HyperbaricO2Care chambers are manufactured under an ISO 13485 quality management system and carry CE marking. Every unit is built as a rigid pressure vessel from aviation-grade steel, with fully welded seams, triple pressure relief and an integrated 4G emergency call system.

This page explains what each of those things actually covers, what documentation ships with your chamber, and what you still need to verify for your own market. It is written for buyers — clinic owners, distributors and procurement teams — who need to know what they are signing off on.

Two different questions: is the factory qualified, and is the product compliant?

These are separate and buyers often conflate them.

Question	What answers it	What it tells you
Is the manufacturer’s quality system controlled?	ISO 13485 certification of the manufacturing facility	Design, production, inspection and traceability follow a documented, audited medical-device quality system
Does the specific product meet market requirements?	CE marking (EU), plus any local registration in your country	The individual model has been assessed against applicable directives and carries a declaration of conformity

A supplier can hold ISO 13485 without every product being CE marked, and a CE mark says nothing about how consistently the factory runs. You want both.

ISO 13485: the quality system behind the build

ISO 13485 is the international standard for quality management systems in medical device manufacturing. In practical terms it means:

• Design inputs and outputs are documented and reviewed, not improvised on the shop floor.
• Materials — including the steel shell and the polycarbonate door — are traceable to batch.
• Each chamber is built to a controlled procedure, with inspection records retained.
• Non-conformities are logged, investigated and closed out rather than quietly reworked.
• Complaints and field feedback feed back into design review.

For a distributor this matters because it is what makes a consistent second order possible. You are not buying a one-off fabrication; you are buying a repeatable process. See our company and facility overview for more on how we manufacture.

CE marking

CE marking indicates that the manufacturer declares the product meets applicable European requirements. Our chambers carry CE marking, and a declaration of conformity is provided with each shipment.

What CE does not do is guarantee clinical efficacy, and it is not a medical approval. It is a conformity mark. If a seller implies that CE means a chamber has been proven to treat a disease, that claim is not supported.

Pressure vessel and structural safety

This is where the engineering matters most, because a chamber is a pressure vessel that people sit inside.

Feature	Specification	Why it matters
Shell	4–5 mm aviation-grade steel	Rigid structure holds its shape under repeated pressurisation cycles; no fabric fatigue
Seams	Fully welded	Continuous weld rather than bonded or stitched joints, built to exceed pressure vessel requirements
Door	Explosion-proof polycarbonate, highly sealed design	Maintains the pressure seal while allowing visual contact with the occupant
Pressure relief	Triple — mechanical, automatic and manual	Three independent paths to relieve pressure; no single point of failure
Operating range	1.1–1.7 atm (POLARIS Duo to 1.75 atm)	Mild hyperbaric range; well inside the design margin of the shell

Safety systems fitted to every chamber

• Triple pressure relief valves — mechanical, automatic and manual override.
• 4G emergency call system — lets the occupant raise an alert even when they cannot reach a physical control.
• Smoke detection — monitored within the cabin.
• Intelligent touchscreen control — with cabin data transmitted to monitoring staff.
• Controlled pressurisation — 5–25 minute press/depress cycles, operator-set.
• Low noise operation — typically ≤50 dB.

Oxygen delivery

Chambers are air-pressurised and fitted with an integrated oxygen concentrator delivering ≥80–90% oxygen (peak 95.6%), so the occupant breathes enriched oxygen without needing a cylinder supply. This is one of the reasons a hard-shell mild chamber behaves very differently from a soft-sided bag filled with room air — a distinction covered in more detail in our chamber comparison guide.

Documentation shipped with each unit

Document	Purpose
Declaration of conformity	Formal statement of the standards the unit meets
CE marking documentation	Evidence of conformity for EU market access
ISO 13485 certificate (manufacturer)	Quality system evidence for procurement and tender files
User manual	Operating, maintenance and emergency procedures
Test and inspection records	Unit-specific build and pressure test documentation
Specification sheet	Dimensions, weight, power, pressure and oxygen data for site planning

What you still need to verify locally

Contact us with your country and intended use and we will tell you exactly which documents we can supply, and which ones your local regulator will expect you to obtain yourself.

Medical disclaimer: the information on this page is provided for general education only and is not medical advice. Hyperbaric oxygen therapy should only be undertaken under the supervision of a qualified healthcare professional. HyperbaricO2Care chambers are mild hyperbaric systems operating at 1.1–1.7 atm and are not intended to diagnose, treat, cure or prevent any disease. Always consult your physician before beginning any oxygen therapy programme.