Certifications

The certifications these chambers hold

HPO.TECH hyperbaric chambers are built and certified to recognised international standards for safety and quality. These are the certifications that back that up - and worth looking for on any chamber.

Which medical-device approvals apply depends on the market and how a chamber is supplied. Tell us the model and where it's going, and we'll confirm exactly where it stands - in writing.

Safety & quality

The standards, and what each one covers

Each of these confirms a specific safety or quality requirement. They are the marks that separate a certified chamber from an unverified one.

CE

Medical device conformity

CE marked against the applicable EU health, safety and environmental requirements for sale on the European market - assessed, not self-declared.

ISO 13485

Medical device quality management

Manufactured to the internationally recognised quality management standard for medical devices, so every chamber is built to the same audited process.

PED

Pressure Equipment Directive

Certified under European pressure-equipment regulation to safely handle the pressures hyperbaric therapy uses.

Türk Loydu

Independent inspection

Every unit independently inspected and pressure-tested for structural integrity by a classification body, before it leaves the factory.

ASME PVHO

Pressure vessels for human occupancy

Designed and built to the ASME PVHO standard - written specifically for pressure vessels that safely hold people under pressure.

NFPA

Fire safety (USA)

Meets NFPA fire-safety guidance for hyperbaric chambers, covering fire prevention and suppression.

Medical device approvals

Medical approvals, country by country

Where chambers are supplied as medical devices, HPO.TECH holds the relevant market authorisations - with more added as the range expands into new territories.

MDR

EU Medical Device Regulation

HPO.TECH holds certification under the EU Medical Device Regulation (MDR).

European Union
MOHAP

Ministry of Health

Every system meets the UAE's medical and technical standards, registered with the Ministry of Health and Prevention.

United Arab Emirates
SFDA

Saudi Food & Drug Authority

Full marketing authorisation held in the Kingdom, cleared by the Saudi Food and Drug Authority.

Saudi Arabia
MDA

Medical Device Authority

Meets Malaysia's regulatory standards for medical devices, registered with the Medical Device Authority.

Malaysia
Wellness or medical

We will tell you exactly where a model stands

Personal and wellness chambers and medically-classified chambers sit under different frameworks, and the approvals that apply change by country. Rather than round it up, we set out the exact certification position for your model and market in writing - so you know precisely what you're buying.

See what to look for in a chamber

Need the paperwork for a specific model?

Tell us the model and the market. We'll confirm its exact certification position and share the documentation.

We handle specification, installation and support, from the first conversation through to handover.

Get in touch
Installed & serviced worldwide US install & servicing - Detroit, Michigan Installed & serviced across Europe CE-marked medical device CE marked Independently inspected We reply in your time zone