In the dynamic field of medical electrical equipment, oxygen safety is paramount. As the demand for advanced medical devices that handle oxygen continues to rise, ensuring compliance with international safety standards is more critical than ever. WHA International is an independent third-party lab providing unparalleled oxygen testing services for medical electrical equipment.
IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance is a globally recognized standard that outlines safety requirements for medical electrical equipment and systems. Within this standard, subsection 11.2.2 focuses on equipment handling oxygen, introducing specific testing options to meet the specific requirements of 11.2.2. These include the Drawn Arc Test (subsection 11.2.2.1a), assessing a material's likelihood of ignition from an electrical circuit failure, and the Compartment Fire Test (subsection 11.2.2.1b 4), evaluating the equipment's housing ability to contain an oxygen fire.
Either of these tests may be recommended following an oxygen hazards review of the medical electrical equipment. WHA offers expert consulting services to assist in this review process, ensuring compliance and safety in medical electrical equipment design and usage.
Drawn Arc Test
WHA’s Drawn Arc test demonstrates compliance in scenarios where electrical compartments are exposed to oxygen or risk exposure due to potential leaks, and when voltage and current exceed the norms of EIC 60601-1 subsection 11.2.2.1a.
Cotton, a common contaminant in healthcare and home environments, is a usual candidate for this test. However, specific filtration methods may allow for the exclusion of cotton or necessitate testing additional materials or contaminants. WHA can assist in making informed choices regarding test configuration and material following a comprehensive oxygen hazard review.
Compartment Fire Test
WHA's Compartment Fire Test assesses medical electrical equipment for meeting the specific requirements of IEC 60601-1 subsection 11.2.2.
This test determines whether medical electrical equipment's housing can contain a fire in severe conditions. To pass, the ignited fire must self-extinguish without breaching the housing, and no toxic amount of gases may pass through the breathing tube.
At WHA, we work in tandem with manufacturers to pinpoint the test configuration, including oxygen concentration, and identify potential leak scenarios. Our approach involves placing ignitors at identified critical locations or near components with high energy potential and the highest likelihood of failure, ensuring a thorough evaluation.
Medical Electrical Equipment
- Ventilators
- Respirators
- High flow nasal cannula (HFNC) O2 delivery,
- Continuous Positive Airway Pressure (CPAPs)
- Oxygen concentrators
- Anesthesia machines
- And more
ISO 17025 Certification
WHA’s ISO 17025 accreditation by Perry Johnson Laboratory Accreditation, Inc. (PJLA) includes Drawn Arc and Compartment Fire Testing. WHA is one of the only labs in the world that offers this testing as an accredited third party.
ISO 17025 is an international standard that specifies the general requirements for the competence, impartiality, and consistent operation of laboratories. This accreditation ensures that testing and calibration are performed to the highest levels of quality and reliability. Furthermore, test results from an ISO 17025 accredited laboratory are more likely to be accepted by global regulatory bodies, significantly facilitating the approval and certification process for medical devices in the target market.