Certifications & Compliance

Certifications & Compliance

Explore OXYAIR’s quality management systems, product certifications, material reports, pressure testing and compliance documentation for global hyperbaric chamber procurement.
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About Compliance in Your Market.
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Quality Management Systems

Our manufacturing and quality-control processes operate under ISO 13485 and ISO 9001 quality management systems. Documented controls cover supplier qualification, incoming material inspection, production procedures, product traceability, nonconforming product handling, corrective actions, and continual improvement.

Product & Pressure Equipment Compliance


CE Conformity: Supporting Product Review for the European Market.
CE conformity demonstrates that an applicable product has been assessed against the relevant European Union requirements for safety, health, and environmental protection. For buyers importing or distributing chambers in the EU, model-specific CE documents provide a clearer basis for checking product compliance, reviewing technical files, and preparing the necessary import or registration materials before placing an order.

UKCA Conformity: Compliance Support for Great Britain
UKCA documentation supports the review of applicable products against the product-safety requirements of Great Britain. By confirming the relevant declaration, test evidence, technical documents, and labeling requirements for the selected model, we help buyers in England, Scotland, and Wales reduce uncertainty during compliance review and prepare a more complete document package for distribution or commercial projects.

PED 2014/68/EU: Pressure Equipment Compliance for Applicable Models
For chamber models within its scope, PED 2014/68/EU documentation provides evidence that pressure-related design, materials, manufacturing controls, safety accessories, and conformity assessment have been reviewed according to applicable European pressure-equipment requirements. This gives distributors, clinics, and technical buyers more useful information for evaluating the pressure-bearing structure and safety configuration, while also supporting supplier approval, project assessment, and tender-document preparation.

PED Certificate

CE certificate

UKCA EMC

UKCA CE

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Material Safety & Environmental Reports

Available evidence includes RoHS documentation, SGS third-party material reports, TPU material test reports, and flame-retardant test reports. These documents help buyers review restricted substances, material identity, and specified safety properties for applicable chamber materials and components.

SGS-Test-Report

ROHS-Test-Report

SGS TPU Test Result

TPU Chamber Flame Retardant Test Report

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Finished Product Testing & Inspection

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We take product quality seriously and do not treat final inspection as a simple formality. Before shipment,
each finished chamber follows a structured 12-step testing process covering appearance, powered-on functions, door closure, pressurization time, pressure holding, full-system operation, noise level, control response, communication functions, labeling, test-video recording, and final packaging. Every key item is checked against the confirmed product specifications, and any issue identified must be corrected and rechecked before the chamber is approved for shipment.

This rigorous and traceable process helps maintain consistent quality across individual units and bulk orders, while reducing the risk of incorrect configurations, unstable operation, installation delays, and avoidable after-sales problems. Inspection records and pre-shipment videos can also be provided, allowing buyers to verify the actual equipment before dispatch and complete remote acceptance with greater confidence.

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