Certifications | Oxygen Health Systems

QUALITY • SAFETY • ENGINEERING

Built to Standard.
Certified to Prove It.

Oxygen Health Systems chambers are manufactured under internationally recognized quality, safety, and engineering standards. Some credentials apply at the company and manufacturing level, while select certifications apply to specific chamber models.

7 Standards

Certifications & credentials

ASME

Code-compliant facility

A+ BBB

Business rating

USA

Designed & engineered

CERTIFIED QUALITY

Our Standards & Certifications

These credentials cover manufacturing, operations, environmental management, pressure-vessel engineering, fire-safety guidance, European conformity, and business standards. The scope is shown clearly so buyers can understand what applies to the company and what applies to specific models.

ISO 13485

MANUFACTURING

ISO 13485 is the international standard for quality management systems in medical-device manufacturing. It governs design controls, supplier oversight, documentation, and traceability across production.

✓ Medical-device quality management framework

ISO 9001:2015

OPERATIONS

ISO 9001 establishes a quality-management framework for consistent production, service delivery, performance monitoring, and continual improvement through independently audited processes.

✓ Independently audited quality processes

ISO 14001

ENVIRONMENTAL

ISO 14001 covers environmental-management systems, including resource use, waste, environmental impact, and regulatory obligations across an organization’s operations.

✓ Audited environmental-management practices

ASME PVHO

SELECT HARD CHAMBERS

ASME PVHO-1 addresses pressure vessels intended for human occupancy. Oxygen Health Systems states that hard-shell chambers are pressure tested to 1.5 times their maximum operating pressure in accordance with PVHO-1.

✓ Select models may carry a valid ASME U Stamp

CE Marking

ALL CHAMBERS

CE marking declares conformity with applicable European health, safety, and environmental requirements for products supplied in the European Economic Area.

✓ European conformity requirements

NFPA

NFPA Standards

SAFETY GUIDANCE

NFPA standards address important hyperbaric fire-safety considerations such as materials, ventilation, ignition risks, operating protocols, and facility requirements.

✓ Facility-level compliance depends on installation

A+ BBB

BBB Accreditation

BUSINESS STANDARDS

BBB accreditation evaluates marketplace practices including transparency, advertising, and responsiveness to customer concerns. Oxygen Health Systems displays an A+ rating.

✓ Independently verifiable business profile

WHY IT MATTERS

Certification Is More Than a Logo

A professional buyer needs to know what each credential covers, how it relates to the manufacturing process, and whether it applies to the exact chamber being considered.

Documented Quality Systems

Recognized quality-management standards help establish controlled processes for design, production, supplier oversight, documentation, and continual improvement.

Pressure-Vessel Engineering

Hard-shell systems require careful attention to pressure-vessel design, materials, testing, construction, and the standards associated with human occupancy.

Clear Certification Scope

Separating company-level credentials from model-specific certifications makes it easier for clinics, wellness facilities, and home buyers to compare options accurately.

PRESSURE VESSEL ENGINEERING

Built With Human-Occupancy Pressure Safety in Mind

ASME PVHO-1 governs the design, materials, and construction of pressure vessels intended for human occupancy. Oxygen Health Systems states that all of its systems are built in an ASME code-compliant facility, that hard-shell chambers are pressure tested to 1.5 times their maximum operating pressure, and that select models are certified to the ASME Boiler and Pressure Vessel Code with a valid U Stamp.

CERTIFICATION TRANSPARENCY

Know Exactly What Applies to Your Chamber

Certification language can become confusing when company-level systems, manufacturing facilities, design standards, and model-specific approvals are presented together. The most useful approach is to verify the scope for the exact chamber you plan to purchase.

Buyer Tip
Before purchase, ask which certifications apply to the manufacturer, which apply to the facility, and which apply to the exact chamber model and configuration you are considering.

Identify the exact chamber model
Start with the specific diameter, pressure rating, hard-shell or soft-shell construction, and configuration you plan to purchase.

Separate company and model credentials
ISO certifications can apply to manufacturing or organizational systems, while ASME or other approvals may apply to a particular design or vessel.

Confirm facility requirements
Installation and fire-safety requirements can depend on the chamber type, intended use, facility design, local rules, and operating environment.

Request supporting documentation
For clinical, commercial, or regulated installations, request the documentation your facility, engineer, insurer, or local authority requires before installation.

SAFETY QUESTIONS

Certification & Safety FAQs

Straightforward answers to common questions about quality systems, pressure-vessel testing, fire safety, certification scope, and post-purchase support.

Are Oxygen Health Systems chambers safe to use at home?

Yes, when operated as directed. Our chambers are manufactured under certified ISO 9001 and ISO 13485 quality management systems, and hard-shell models are pressure tested to 1.5 times their maximum operating pressure before shipping. Every system also comes with operational training, and we recommend completing it before your first session and consulting your healthcare provider before starting therapy.

How do I know the pressure vessel itself is structurally sound?

All of our systems are built in an ASME code compliant facility, and hard-shell chambers are proof tested to 1.5 times their maximum operating pressure in accordance with the ASME PVHO-1 standard for Pressure Vessels for Human Occupancy. Select models go further and are certified to the ASME Boiler and Pressure Vessel Code with a valid U Stamp – if that level of certification matters for your facility, our team can point you to the models that carry it.

What happens if the power goes out during a session?

Our chambers are designed for a controlled, safe exit rather than an abrupt one. Systems include pressure relief valves, and soft chambers feature dual relief valves plus a power outage alarm that alerts you immediately. Internal and external pressure gauges mean both the occupant and anyone outside can monitor the chamber at all times.

Is fire a risk in a hyperbaric chamber?

Fire safety is taken seriously in any oxygen-enriched environment, which is why our designs and operating guidance take NFPA fire safety requirements into account. Our multiplace systems are engineered to maintain safe ambient oxygen levels during operation, and every chamber ships with clear guidance on what can and cannot be brought inside. Following the provided protocols keeps ignition risk extremely low.

What certifications should I look for when comparing chamber brands?

At minimum, look for a manufacturer with certified quality management (ISO 9001 and ISO 13485), documented pressure testing to a recognized standard such as ASME PVHO-1, and transparent answers about which certifications apply to which models. Oxygen Health Systems holds ISO 9001, ISO 14001, and ISO 13485 certification, carries CE marking on its chambers, builds in an ASME code compliant facility, and will tell you exactly what applies to the specific chamber you’re considering.

What support do I get after purchase if something goes wrong?

Every chamber is backed by a 3-year full-coverage warranty and supported by our US-based team, with guaranteed responses within two hours during business hours. Replacement parts are dispatched by our engineers as needed, and our chambers are built for decades of regular use – so support is there for the rare occasion you need it.

BUILT BY ENGINEERS • BUILT FOR SAFETY

Need Certification Details for a Specific Chamber?

Speak with the Oxygen Health Systems team to confirm which quality certifications, pressure-vessel standards, documentation, and installation requirements apply to the chamber model you are considering.