Trust & Compliance

Certifications

Every Oxytech chamber is engineered and manufactured to internationally recognized pressure vessel and medical device standards — audited across our two production facilities in İzmit-Kocaeli, Türkiye.

CE Certified
ISO 13485 Medical Device Production
Manufacturing since 2008
Quality Management

Company-wide management system certifications

Our production entity holds the following ISO management system certifications, covering quality, medical device manufacturing, environment, safety, customer satisfaction and risk management.

ISO 9001:2015
Quality Management System

The foundation of our production process — consistent quality control from raw material to final assembly.

ISO 13485:2016
Medical Device Quality Management

Certifies our production system for medical device manufacturing, covering our medical hyperbaric chamber lines.

ISO 14001:2015
Environmental Management System

Our commitment to environmentally responsible manufacturing practices across both production facilities.

ISO 45001:2018
Occupational Health & Safety

Systematic management of workplace health and safety for every employee on our production floor.

ISO 10002:2018
Customer Satisfaction & Complaint Management

A structured system for handling customer feedback and ensuring consistent after-sales service quality.

ISO 31000:2018
Risk Management System

Enterprise-wide risk identification and management, from engineering design through to delivery.

Product Standards

Design & pressure vessel standards

All chambers are engineered and manufactured per applicable international pressure vessel and medical device standards. Exact applicable standards vary by chamber type — see individual product pages for details.

ASME PVHO-1Pressure Vessels for Human Occupancy
EN 14931Pressure Vessels for Human Occupancy
2014/68/EUPressure Equipment Directive (PED)
ASME Sec. VIII, Div. 1Boiler & Pressure Vessel Code
MDDMedical Device Directive
NFPA 99Health Care Facilities Code
EN 93/42 EECMedical Device Standard
EN 13445-3Unfired Pressure Vessels
Manufacturing Quality

Certified welding & inspection

Every pressure vessel is welded and tested under certified processes — not outsourced, but performed in-house across our own production facilities.

Certified Welding

  • EN ISO 3834-2 certified welding quality management
  • AD2000-Merkblatt compliant pressure vessel fabrication
  • Submerged Arc (SAW), Metal Arc (GMAW), TIG (GTAW) & Electrode (SMAW) welding

Special Welding Tests

  • Radiographic Test
  • Ultrasonic Test
  • Dye Penetrant Test
  • Magnetic Particle Test
  • Visual Test
Sector-Specific Compliance

Recognized across every application

Beyond our core certifications, individual product lines carry sector-specific compliance relevant to their use case.

CE Marking — All Chambers
IMCA D-Series — Diving Chambers
MDD — Medical Chambers
NFPA 99 — Health Care Facilities
Third-party attestation

In addition to the certifications above, our chambers and pressure equipment undergo third-party compliance attestation for specific projects and export markets. Documentation is provided per order upon request.

Request a Quote

Tell us about your project.

Share your requirements and our engineering team will prepare a tailored configuration and quotation — typically within 2 business days.

✉ info@oxytech.com.tr
✆ +90 532 367 65 41
📍 Başiskele / Kocaeli, Türkiye