HPOTECH certifications
All HPOTECH hyperbaric chambers are manufactured to the highest international standards and certified by recognized organizations to ensure safety, quality and reliability in every use.
- Medical Device Regulations
Certifications for use in a medical environment
93/42/EEC
Medical Devices Directive (MDD)
Directive 93/42/EEC ensures that hyperbaric chambers meet the safety and performance requirements for medical devices within the European Union. This certification ensures that the products are safe for clinical use.
MDR
Medical Devices Regulation
Under certification
The new Medical Device Regulation (MDR 2017/745) is gradually replacing the MDD with stricter requirements. HPOTECH is in the process of certification to ensure full compliance with the new standards.
- Pressure Vessel Pressure & Safety Regulations
Structural integrity and pressure safety certifications
ASME PVHO
Pressure Vessels for Human Occupancy
The ASME PVHO (American Society of Mechanical Engineers) standard specifies the design, construction and inspection requirements for pressure vessels intended for human habitation. It ensures the structural integrity and safety of the chambers.
PED
Pressure Equipment Directive (2014/68/EU)
The European Pressure Equipment Directive ensures the safe construction and operation of pressure vessels. It covers design, materials, production and conformity assessment for all pressure equipment.
Turk Lloydu
Hydrostatic Testing & Conformity Assessment
Turk Lloydu is an internationally recognised certification body that conducts hydrostatic testing and conformity assessments. It verifies that each chamber withstands operating pressures safely.
- Product & Work Safety Standards
Ensuring safe operation and use
2006/42/EC
Machinery Directive
The Machinery Directive ensures that hyperbaric chambers meet the essential health and safety requirements. It covers mechanical systems, electrical equipment, control systems and operator safety.
NFPA
National Fire Protection Association (USA)
NFPA standards set fire safety requirements for hyperbaric environments, including construction materials, fire suppression systems, emergency procedures and personnel training.
ANEP 26
Ergonomic Military Standards
ANEP 26 specifies ergonomic requirements for military equipment that are also applicable to hyperbaric chambers: space design, operator comfort, accessibility of controls and fatigue reduction.
2001/95/EC
General Product Safety Directive
The General Product Safety Directive ensures that all consumer products placed on the EU market are safe. It imposes obligations on manufacturers for risk assessment and after-sales monitoring.
- Quality Management Systems
ISO certifications for excellent quality and management
ISO 13485
Medical Devices Quality Management System
ISO 13485 is the international standard for medical device quality management systems. It ensures that HPOTECH maintains consistent design, manufacturing, installation and service processes that meet regulatory requirements.
ISO 9001
quality management system
ISO 9001 is the most recognised quality management standard worldwide. It ensures that HPOTECH provides products and services that consistently meet customer expectations and regulatory requirements.
ISO 14001
environmental management system
ISO 14001 certifies that HPOTECH manages its environmental responsibilities in a systematic way. This includes ��waste reduction, energy efficiency and minimizing the environmental footprint in production.
ISO 27001
information security management system
ISO 27001 ensures that HPOTECH protects sensitive information through a systematic information security management framework. It covers the protection of customer data, technical plans and patient information.
Our Commitment to Happiness
Each certification represents HPOTECH's commitment to safety, quality and excellence. Our hyperbaric chambers undergo rigorous testing and inspections by independent organizations to ensure they meet or exceed international standards.