Evaluation of Oxygen Concentrators
Oxygen supplementation is an integral part of the management of patients with chronic, acute-on-chronic, or acute respiratory disorders. The amount of supplemental oxygen depends on the individual patient’s needs under various conditions. The managing healthcare team typically prescribes the endpoint of treatment, for example, a target value for oxygen saturation. The amount of supplemental oxygen can be controlled by the flow rate.
Oxygen concentrators have integrated flow and pressure sensors. These are essential for detecting patient inhalations and maintaining optimal pressures for oxygen generation. Such sensors may require calibration and periodic maintenance to ensure reliability and precision, which often takes place during the design/ manufacturing stage.
Oxygen Concentrator Testing is conducted in various stages:
- Research and Development (R&D)
- Manufacturing and Quality Control
- Service and Calibration
- Verification of Device Performance Between Patients
Testing According to National and International Standards:
TÜV Rheinland conducts tests as per IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility), and ISO 80601-2-69 standards.
IEC 60601 series of technical standards ensure the safety and performance requirements of medical electrical equipment are met. It serves to ensure that no single electrical, mechanical, thermal, or functional failure shall pose an unacceptable risk to patients and/or operators. We conduct the “Electromagnetic Immunity” test as per IEC 60601-1-2 (EMC Standards) of medical devices.
Our Capability:
TÜV Rheinland supports the testing of basic safety and essential performance of an oxygen concentrator in combination with its accessories such as ME equipment, intended to increase the oxygen concentration of gas delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment, including transit-operable use by a single patient under various environments such as private / public transportation as well as in commercial aircraft.
Benefits at a glance:
- TÜV Rheinland is an international certification body and hence, test reports can be used to cater to local as well as international markets
- Testing of the product as per national and international standards
- Save time and cost by considering compliance and testing requirements during the design and development stage
- One-stop-solution for all reliability, safety, and performance testing
- Multiple test setups to handling multiple samples simultaneously, thereby reducing TAT (Turn Around Time)
Why TÜV Rheinland:
In a field that is characterized by fast-moving cycles of innovation, competence and quality are important factors for success. Place your trust in TÜV Rheinland’s experts. We are a notified body authorized to test your medical products and assist you with the right evaluation process.
Types of Oxygen Concentrators We Test:
Stationary High-flow Oxygen Concentrators with 3, 5, 8, and 10 LPM Units
- Continuous Flow Oxygen Concentrators
- Pulse Dose Oxygen Concentrators
