Our Total Quality Management system covers design, manufacturing, testing, functionality and customer-service controls for HPOTECH hyperbaric, hypobaric and multibaric chamber systems. The certificate set reviewed on June 30, 2026 confirms ISO 13485 design, production, sales and after-sales scope, ISO 9001/14001/45001 service scopes and ASME pressure-vessel manufacturing authorization.
Certifications and Total Quality Management for hyperbaric chamber manufacturing
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.
Quality testing
Our quality control team coordinates manufacturing records, in-house functional tests, third-party test documentation and certification evidence according to the applicable project file and destination-market requirements.
Safety and compliance
Safety standards and project documentation support pressure-vessel integrity, installation planning and serviceability for professional chamber systems.
Certifications
HPOTECH hyperbaric chamber documentation includes confirmed ISO quality-system certificates, ASME pressure-vessel manufacturing authorization and project-specific files that should be reviewed per model and destination market.
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
93/42/EEC – Medical Devices Directive (MDD)
This European Union medical-device framework sets essential safety and performance requirements for applicable devices. For procurement, HPOTECH provides model- and market-specific conformity documentation instead of making treatment-use claims.
Medical Devices Directive (MDR)
HPO TECH documentation references the transition from the Medical Devices Directive to the EU Medical Device Regulation framework. MDR evidence should be reviewed per model, configuration and intended destination market.
UKCA – UK Conformity Assessed
UKCA Declaration of Conformity CA No. 202023370 covers HPOTECH hyperbaric oxygen treatment chambers, respirators and oxygen concentrator under General Product Directive 2001/95/EC. It was issued on November 22, 2025 and is valid through November 22, 2026; applicability should still be reviewed per delivered product and configuration.
Medsafe, New Zealand
Medsafe WAND reference 240408-WAND-735V2N lists HPOTECH Hyperbaric GMDN 12061 as an active Class IIb hyperbaric chamber entry for New Zealand, with HPOTECH Medikal Ve Teknik Cozumler San ve Tic AS as manufacturer.
Thai FDA – Thailand
Thai FDA import-notification file 68-2-2-2-0003878 covers Hyperbaric Oxygen Therapy System CKBO12 for the named Thai importer. It was issued on April 17, 2025 and is valid until December 31, 2029; importer and model scope should be verified for Thailand projects.
FDA – Ghana
Ghana FDA documentation is treated as a market-specific approval item and should be reviewed for the relevant chamber model, configuration and importer file.
Saudi Food and Drug Authority (SFDA)
Saudi SFDA approval status should be verified per chamber model, configuration and local importer file before a system is specified for the Kingdom of Saudi Arabia.
UAE MOHAP / EDE Files
UAE MOHAP and Emirates Drug Establishment regulatory-advice documents reviewed for Zeugma Monoplace and Matrix 2.4 ATA state medical-device clearance or advice for named applicants. The documents also state they are not registration certificates, so licensing and importer obligations must be verified per project.
Pressure vessel and safety regulations
PVHO Review - Pressure Vessels for Human Occupancy
PVHO-1 defines engineering requirements for pressure vessels for human occupancy. Buyers should verify whether the selected HPOTECH model and configuration has PVHO-specific documentation in the approved technical file.
ASME U-Stamp
HPO TECH holds ASME Certificate of Authorization No. 62897 for the manufacture of pressure vessels at its Istanbul facility and controlled field sites. The authorization is dated December 22, 2025 and expires December 22, 2028.
PED – Pressure Equipment Directive
The EU Pressure Equipment Directive regulates the design, manufacture and conformity assessment of pressure equipment placed on the EU market. PED evidence should be checked per pressure-vessel configuration.
Türk Loydu - Hydrostatic Testing and Conformity Assessment:
HPO TECH uses third-party hydrostatic and conformity-assessment documentation in chamber QA workflows; project records should identify the witnessing body and test scope per delivered chamber.
Product and occupational safety standards
2006/42/EC – Machinery Directive
This directive covers machinery safety requirements such as moving parts, emergency stops and user interfaces. Conformity evidence should be reviewed in the model-specific technical file.
Fire Safety - Facility Code Review
Fire-safety and facility-planning requirements for hyperbaric installations depend on the project country, facility type and chamber configuration.
Ergonomic Review - Tender-Specific Documentation
For defense or military tenders that require ergonomic-standard conformance, request model-specific documentation. Otherwise review ergonomic design through product drawings and specifications.
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
ISO 13485 – Medical Devices Quality Management System
The ISO 13485:2016 certificate reviewed for HPOTECH covers hyperbaric oxygen therapy system pressure-chamber design, production, sales and after-sales activities.
ISO 9001 – Quality Management System
This directive covers machinery safety requirements such as moving parts, emergency stops and user interfaces. Conformity evidence should be reviewed in the model-specific technical file.
ISO 45001 – Occupational Health and Safety Management System:
The ISO 45001:2018 certificate reviewed for HPOTECH covers occupational health and safety management for medical-device sales and after-sales services.
ISO 14001 – Environmental Management System
The ISO 14001:2015 certificate reviewed for HPOTECH covers environmental management for medical-device sales and after-sales services.
ISO certificate scope - documented quality, environment and safety systems
Current certificate evidence covers ISO 13485:2016 for hyperbaric oxygen therapy system design, production, sales and after-sales activities, plus ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 for medical-device sales and after-sales services.
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 is a pressure-vessel quality-control step used to check the structural integrity of a chamber under controlled conditions. The procedure pressurizes the vessel with water to a defined test level above its normal working pressure, according to the applicable test plan and documentation package.
The test helps verify the pressure boundary, welds, seals and structural components before delivery. The result is documented as engineering quality evidence for procurement, installation and maintenance review.
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: confirmed ISO quality-system certificates, ASME pressure-vessel manufacturing authorization, and model-specific market-access files that should be reviewed before procurement.
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 — ISO certificates, ASME authorization details, technical files and model-specific market-access documents — 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 supplies chambers internationally; market access should be verified per model, intended use, importer and destination country.
What is PVHO-1, and what evidence should buyers request?PVHO-1 is a pressure-vessel standard for human occupancy. Where this standard is required, buyers should request model-specific pressure-vessel, viewport and inspection documentation for the selected configuration.
Do HPOTECH chambers carry UKCA marking for the UK market?UKCA Declaration of Conformity CA No. 202023370 covers HPOTECH hyperbaric oxygen treatment chambers, respirators and oxygen concentrator under General Product Directive 2001/95/EC, issued November 22, 2025 and valid through November 22, 2026. For Great Britain projects, review applicability per delivered product and configuration.
Is HPOTECH registered with medical-device authorities outside the EU?Beyond CE/UKCA/ISO/ASME files, reviewed market documents include Medsafe WAND New Zealand, Thai FDA CKBO12 import notification, Malaysia MDA registration certificate GB6211722-106122 and UAE MOHAP/EDE regulatory-advice notifications. Saudi and Ghana files remain model/importer gates until current authority evidence is supplied.
Are HPOTECH chambers independently pressure-tested before delivery?Where required by project specification, chamber-specific hydrostatic test records and third-party inspection documents can be included in the procurement file. Verify the inspection body, serial number, test date and acceptance criteria on the delivered-unit documentation.
Do HPOTECH chambers meet fire-safety requirements?Fire-safety requirements for hyperbaric installations depend on local code, oxygen-system design, facility layout and the authority having jurisdiction. Request the project fire-safety submittal and local sign-off where required.
Which ISO standards does HPOTECH operate under?The certificate evidence reviewed on June 30, 2026 confirms ISO 13485:2016 for pressure-chamber design, production, sales and after-sales activities, plus ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 for medical-device sales and after-sales services.
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.
