Is Your Hyperbaric Chamber Safe? Understand the Importance of CE, ISO, and RoHS Certifications

Introduction

With the widespread application of Hyperbaric Oxygen Therapy (HBOT) in rehabilitation medicine, anti-aging, and chronic disease management, more individuals and institutions are investing in hyperbaric chamber equipment. However, not all chambers on the market meet international safety standards. Choosing equipment certified with CE, ISO, and RoHS is the first step to ensuring safe and compliant oxygen therapy.

This article will explain why these three certifications are crucial and how to determine whether your hyperbaric chamber is truly safe and reliable.

What Determines the Safety of a Hyperbaric Chamber?

As a device designed to deliver pure oxygen in a high-pressure environment, a hyperbaric chamber must meet key safety criteria:

• Structural strength and airtightness: Able to withstand 1.5–3 ATA without risk of explosion;

• Oxygen concentration control system: Prevent oxygen toxicity or hypoxia.

• Emergency pressure release and alarm systems: Ensure quick response in critical situations.

• Medical-grade materials: Non-toxic, high-pressure resistant, flame-retardant, and corrosion-proof.

These features are only reliable when tested and verified through recognized international certification systems.

Why Are International Certifications So Important?

In the medical device industry, CE, ISO 13485, and RoHS are three of the most widely recognized certifications, each safeguarding different aspects of product safety and compliance:

• CE Certification: A mandatory conformity mark for EU markets, indicating that the product meets European health, safety, and environmental protection requirements;

• ISO 13485 Certification: A global standard for quality management systems specific to medical devices, covering the entire product lifecycle;

• RoHS Certification: A European directive restricting hazardous substances in electronic and electrical equipment, ensuring materials are safe for users and the environment.

These certifications are not just “stamps”—they are international trust marks that help institutions and buyers identify high-quality, compliant products.

CE Certification: Your Ticket to the EU Market

CE (Conformité Européenne) is the fundamental compliance requirement for selling medical devices in EU member states. Hyperbaric chambers are classified as Class IIb medical devices, which means they must pass assessments from a Notified Body, including:

• Clinical evaluations and risk analysis reports;

• Complete technical documentation;

• Product testing and compliance reports;

• On-site factory quality audits.

Only after passing these assessments can the chamber bear the CE mark and be legally sold and used within Europe.

ISO 13485 Certification: A Systematic Approach to Quality Management

ISO 13485 is the international standard for quality management systems in the medical device industry. It goes beyond product quality to ensure a consistent, traceable, and compliant manufacturing process, including:

• Documented design and development processes;

• Risk management procedures;

• Standardized supply chain control;

• After-sales service, recall procedures, and continual improvement plans.

Manufacturers certified with ISO 13485 are better equipped to deliver consistent, internationally compliant medical-grade products.

RoHS Certification: A Green Label for Health and Environmental Safety

RoHS (Restriction of Hazardous Substances) is a directive by the European Union that limits the use of toxic substances like lead, cadmium, mercury, hexavalent chromium, and certain brominated flame retardants in electrical and electronic products.

For hyperbaric chambers that contain electronic components, RoHS compliance ensures:

• Safe, non-toxic materials that pose no health risk to users;

• Environmentally friendly production, enabling smooth customs clearance and market entry in Europe;

• Enhanced brand credibility, especially among eco-conscious and high-end consumers.

The Hidden Risks of Uncertified Products

Some low-cost hyperbaric chambers are marketed as “medical-like” but lack recognized certification. Using such products may lead to:

• Chamber leaks or pressure failure due to poor welding or structural flaws;

• Malfunctioning oxygen control, leading to oxygen deficiency or toxicity;

• Absence of emergency mechanisms during crises;

• Use of toxic or restricted substances in materials;

• Legal ambiguity in liability or insurance in case of adverse events.

How to Verify a Supplier’s Certification?

• Request official documentation: CE certificate, ISO 13485 certificate, RoHS compliance declaration.

• Confirm the certifying body (e.g., TÜV, SGS, BSI, Intertek) is internationally recognized;

• Use official platforms (e.g., EUDAMED, ISO registries) to verify certificate numbers;

• Check for expiry dates and ensure the certificate applies to the exact product model.

Oxyair Hyperbaric Chambers: Globally Certified, Trustworthy & Safe

As a leading hyperbaric chamber manufacturer, Oxyair offers products that have passed:

• CE Certification: Compliant with EU MDR standards and approved for clinical use in European healthcare facilities;

• ISO 13485 Certification: Ensures full quality control across all stages of manufacturing with OEM/ODM services available;

• RoHS Compliance: All electronic parts are made with environmentally friendly and safe materials.

We are committed to delivering high-performance, globally compliant hyperbaric chambers for hospitals, clinics, wellness centers, and individual use.

Conclusion

Purchasing a hyperbaric chamber isn’t just a business decision—it’s a responsibility to health and safety. CE, ISO, and RoHS certifications are not just paperwork but guarantees of quality, material safety, regulatory compliance, and peace of mind.

Always verify documentation before purchase and stay away from uncertified or suspiciously low-priced devices. Choose a manufacturer like Oxyair that values your safety as much as you do.

Need help selecting the right model or verifying certificates? Contact us today for expert one-on-one guidance and documentation support.