Certifications and Total Quality Management for hyperbaric chamber manufacturing

Our Total Quality Management system includes all aspects across design, manufacturing, testing, functionality, and customer service to ensure our hyperbaric oxygen systems are effective in therapy, but also safe, reliable, and accessible for patients.

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Patents

All our hyperbaric, hypobaric, and multibaric chamber models are protected by design and utility model patents, registered with Türk Patent (the Turkish Patent and Trademark) and internationally recognized through the WIPO Hague System. These patents cover Turkey, the EU, and the USA, with global filings in progress.

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Quality testing

Our quality control team coordinates the manufacturing, in-house testing, including the third-party testing process according to international regulations, procedures, and criteria for the certification of medical devices for medical HBOT & wellness applications.

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Safety and compliance

Safety standards and certifications play a vital role in guaranteeing the quality and reliability of hyperbaric chambers used for hyperbaric oxygen therapy (HBOT).

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Certifications

HPO TECH hyperbaric chambers comply with a wide range of international regulatory standards to ensure safety, quality, and operational excellence.

These certifications are categorized based on their focus, covering medical device compliance, pressure vessel safety, product and occupational safety, quality management, and regional market approvals.

Medical Device Regulations

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Medical Device Regulation (MDR) 
The company has transitioned from the MDD (Medical Devices Directive) certification to the new MDR (Medical Device Regulation) framework. This transition reflects our commitment to aligning with the latest EU medical device regulations for enhanced safety and performance standards.
CE
93/42/EEC – Medical Devices Directive (MDD)
This European Union directive ensures that HPO TECH hyperbaric chambers meet essential safety and performance requirements for medical devices. Compliance with MDD guarantees that the chambers are suitable for therapeutic use within healthcare settings.
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UKCA – UK Conformity Assessed
Applicable to the UK market, this certification confirms that our chambers meet post-Brexit regulatory requirements for medical devices, ensuring compliance with safety, performance, and environmental protection standards.
Hyperbaric Chamber Certifications
Medsafe, New Zealand
New Zealand’s medical device regulatory body ensures that HPO TECH chambers meet national healthcare standards for safety and effectiveness.
Hyperbaric Chamber Certifications
Thai FDA – Thailand 
The Thai FDA ensures our hyperbaric chambers meet strict safety and performance standards before they can be legally sold. Approval signifies regulatory compliance, allowing distribution in Thailand.
Certifications
FDA – Ghana
The Ghana FDA certification marks a decisive step forward in our mission to support healthcare, wellness, recovery, and human performance across Africa.
Certifications
Saudi Food and Drug Authority (SFDA)
HPO.TECH hyperbaric chambers are certified as medical devices by the Saudi Food and Drug Authority (SFDA) and hold full marketing authorization in the Kingdom.
Certifications
UAE – Ministry of Health
HPO.TECH is certified by both the UAE Ministry of Health and Prevention (MOHAP) and the Emirates Drug & Medical Devices Regulation Agency (EDE). This double certification affirms that every HPO.TECH system meets the UAE’s strictest medical and technical standards for safety, quality, and performance.

Pressure vessel and safety regulations

Hyperbaric Chamber Certifications
ASME PVHO – Pressure Vessels for Human Occupancy
This American Society of Mechanical Engineers (ASME) standard ensures that our hyperbaric chambers are designed and built to safely accommodate human occupants under pressurized conditions, reducing risks associated with high-pressure environments.
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ASME U-Stamp
An ASME U-stamp is a certification mark from the American Society of Mechanical Engineers (ASME) indicating that an unfired pressure vessel complies with strict safety, design, fabrication, and testing standards under Section VIII, Division 1 of the Boiler and Pressure Vessel Code (BPVC). It signifies authorized manufacturing and rigorous inspection.
PED
PED – Pressure Equipment Directive
An European standard that regulates the design, manufacturing, and testing of pressurized equipment, ensuring the hyperbaric chambers can safely handle the pressures required for hyperbaric therapy.
Hyperbaric Chamber Certifications
Turk Lloydu – Hydrostatic Testing and Conformity Assessment:
Turk Lloydu provides certification for pressure testing and structural integrity of hyperbaric chambers, verifying their safety and compliance with international hydrostatic standards.

Product and occupational safety standards

CE
2006/42/EC – Machinery Directive
This directive ensures the mechanical safety of hyperbaric chambers, covering aspects such as moving parts, emergency stops, and user interfaces to protect operators and patients from mechanical hazards.
Hyperbaric Chamber Certifications
NFPA – National Fire Protection Association (USA)
Establishes fire safety guidelines for hyperbaric chambers, ensuring compliance with strict fire prevention and suppression standards within medical environments.
Hyperbaric Chamber Certifications
ANEP 26 – Ergonomic Military Standards
This ergonomic standard establishes general human engineering design criteria for military systems, subsystems, equipment, and facilities
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2001/95/EC – General Product Safety Directive
This European Union directive sets general safety requirements for products placed on the EU market. HPO TECH hyperbaric chambers comply with its provisions, complementing the device-specific CE marking under the Medical Device Regulation (MDR).

Quality and management systems certifications

Hyperbaric Chamber Certifications 02
ISO 13485 – Medical Devices Quality Management System
This certification confirms that HPO TECH adheres to internationally recognized standards for medical device manufacturing, ensuring quality control throughout the product lifecycle.
Hyperbaric Chamber Certifications 02
ISO 9001 – Quality Management System
This directive ensures the mechanical safety of hyperbaric chambers, covering aspects such as moving parts, emergency stops, and user interfaces to protect operators and patients from mechanical hazards.
Hyperbaric Chamber Certifications 02
ISO 45001 – Occupational Health and Safety Management System:
Ensures that our chambers are manufactured under a management system that prioritizes employee safety and health in the workplace.
Hyperbaric Chamber Certifications 02
ISO 14001 – Environmental Management System
Confirms that the company follows environmental best practices in its manufacturing processes, reducing ecological impact and ensuring sustainability.
Hyperbaric Chamber Certifications 02
ISO 27001 – Information Security Management System
Ensures that the company protects sensitive patient and operational data through strict information security management protocols.
Turk Lloydu Certification

Quality control 

Each hyperbaric chamber is inspected by Türk Loydu after manufacturing in compliance with the management systems standards in quality, environmental safety, occupational health and safety, energy management, and structural integrity.

Hydrostatic Testing for Hyperbaric Chambers

Hydrostatic testing plays a critical role in guaranteeing the safety and structural integrity of hyperbaric chambers. This non-destructive quality control procedure involves pressurizing the chamber with water (deionized water to avoid corrosion) to a level exceeding its maximum operating pressure.

By simulating the real-world pressure conditions of HBOT sessions, hydrostatic testing helps identify any weaknesses in the chamber’s materials, welds, or seals before they pose a risk during therapy. This important quality control step ensures patients can experience the benefits of HBOT with confidence, knowing the chamber has undergone rigorous testing for leaks and structural integrity.

Frequently asked questions

Everything you need to know about HPO TECH hyperbaric chambers — configuration, certifications, delivery and support.

Which regulatory certifications does HPOTECH hold, and what does each one cover?

HPOTECH holds certifications across three distinct regulatory frameworks, each covering a different dimension of product and quality compliance: the EU Medical Devices Regulation (MDR 2017/745) for medical device certification, CE marking for European market entry, and ISO 13485 for quality management certification.

Does ISO 13485 apply to all HPOTECH chamber models, or only to specific SKUs?

ISO 13485 is a quality management system standard applied at the manufacturer level — it covers HPOTECH’s design controls, production processes, and post-market quality systems, applying across all models manufactured rather than to individual SKUs.

How do I obtain the certification documents for a specific HPOTECH chamber model before procurement?

Model-specific certification documentation — EU MDR (2017/745) certificates, ISO 13485 certificates, and CE Declarations of Conformity — can be requested directly from HPOTECH’s sales and engineering team as part of the pre-procurement spec-brief process.

Are HPOTECH chambers certified for markets beyond the US and Europe?

HPOTECH chambers are certified under the EU Medical Devices Regulation (MDR 2017/745), the framework international markets recognise as the certification baseline, with additional local registrations where individual markets require them.

What is ASME PVHO-1, and are HPOTECH chambers certified to it?

ASME PVHO-1 is the American Society of Mechanical Engineers’ Safety Standard for Pressure Vessels for Human Occupancy, the benchmark for hyperbaric pressure boundaries and acrylic viewports. HPOTECH hard-shell chambers are built and certified to ASME PVHO-1, with acrylic windows individually certified at 30 mm and 50 mm thicknesses.

Do HPOTECH chambers carry UKCA marking for the UK market?

Yes. HPOTECH holds UKCA marking (2026), the United Kingdom Conformity Assessed mark required for medical and pressure equipment placed on the Great Britain market after the transition from CE.

Is HPOTECH registered with medical-device authorities outside the EU?

Yes. Beyond CE marking, HPOTECH chambers are registered with the Saudi Food and Drug Authority (SFDA), the Thai FDA, Medsafe New Zealand, the Malaysian Medical Device Authority, and the UAE Ministry of Health.

Are HPOTECH chambers independently pressure-tested before delivery?

Yes. Every chamber is independently type-tested by Turk Loydu and hydrostatically pressure-tested before delivery, verifying the pressure boundary against its rated working pressure.

Do HPOTECH chambers meet fire-safety requirements?

HPOTECH chamber materials are independently flammability-tested, and fire-detection and suppression provisions are engineered into installations in line with NFPA hyperbaric-facility guidance where local codes require them.

Which ISO standards does HPOTECH operate under?

ISO 13485 (medical-device quality management), ISO 9001 (quality), ISO 14001 (environmental) and ISO 45001 (occupational health and safety) – manufacturer-level systems applying across all chamber models.

Are hyperbaric chambers legal to own and operate?

Yes, they are legal to own. Commercial and clinical operation is governed by the local health or workplace-safety authority in the operator’s jurisdiction; HPOTECH supplies the certified equipment and documentation for that local approval process.