Certification information buyers can review on Biotos.
Review current regulatory, quality-management and pressure-vessel information, and request the documentation package for the exact chamber you are considering.
Quality, regulatory and pressure-vessel documentation.
Biotos can provide current manufacturer certification information and model-specific documentation where required for procurement or project review.
EU MDRMedical Device Regulation
European medical-device regulatory framework. Biotos can provide the current documentation applicable to the chamber and configuration being considered.
ISO 13485Medical device quality management
Quality-management standard focused on the design, manufacture and service of medical devices.
ISO 9001Quality management
Quality-management framework for consistent products, processes and customer requirements.
ISO 45001Occupational health & safety
Management framework for occupational health and safety.
ISO 14001Environmental management
Environmental management framework covering systematic environmental responsibilities.
ISO 27001Information security
Information-security management framework for the protection of sensitive information.
PED 2014/68/EUPressure equipment
Pressure-equipment framework relevant to chamber pressure-vessel safety where applicable.
ASME PVHOPressure Vessels for Human Occupancy
Pressure-vessel standard referenced in current Biotos/HPOTECH technical documentation.
Need documentation for a specific chamber?
Keep the enquiry on Biotos. Ask for the exact documentation package for the model and configuration being considered.
Certification is not identical across the range.
Most suppliers publish one blanket statement. Biotos publishes it per model, because a hyperbaric medical device and a hypobaric training chamber genuinely differ — and a procurement officer needs to know which one they are buying.
| Model | CE | MDD-MDR Class IIb | PED 2014/68/EU | ASME |
|---|---|---|---|---|
| Zeugma | Yes | Yes | Yes | PVHO |
| Petra | Yes | Yes | Yes | PVHO |
| Matrix | Yes | Yes | Yes | PVHO |
| Atlantis | Yes | Yes | Yes | PVHO |
| Mediterranean | Yes | Yes | Yes | PVHO |
| Titan | Yes | Yes | Yes | Sec. VIII Div II |
| Apex (hypobaric) | Yes | No — not a medical device | Yes | — |
Source: official HPO Tech technical specification sheets. Trojan is not listed because its manufacturer sheet is not yet in the documentation set — request it and we will supply it directly. The manufacturer also holds ISO 13485, ISO 9001, ISO 45001, ISO 14001 and ISO 27001.
Need documentation for a specific chamber?
Request the current model documentation together with project pricing so your team can review the exact chamber and configuration.