Testing of Ventilator and Breathing Assistance Components

Solution

• Tensile, compression, and torque testing programs are run by computers.
• Single components, custom grips, and fixtures.
• Flexible software to implement bespoke procedures or global standards.

Benefits

• Intuitive software allows testing to be made accurate based on design or regulatory standards.
• Changeable grips and fixtures enable various tests to be done on the same system.
• Routines are preprogrammed to facilitate quality testing at the point of manufacture.
• Extensive traceability and Grand Audit Reports.

Requirement

Mechanical ventilators are important clinical tools that assist the breathing of patients who are unable to adequately sanction gasping. They are critical in hospitals, long-term care centers, and home-based care stations when there is a need for a planned operation, emergency surgeries, a long-term respiratory disease, or acute care services.

In the case of global health crises, like the COVID-19 pandemic, the demand for ventilators increased, which is why not only conventional medical manufacturers but also other industries started to create rapid-deployment ventilators, including open-source or reverse-engineered models.

Newly developed ventilators, such as continuous positive airway pressure (CPAP) systems, are characterized by portability as well as advanced electronic control. The main subsystems are the following:

• Electrical, gas, and pressure generation: power supply
• Gas delivery: flow regulators, accumulators, and blenders
• Patient circuit, tubing, PEEP valves, humidification, and filters
• Supervising: customary flow, pressure, volume, and gas concentrations checking
• Safety specifications: The presence of particle/bacterial filters, moisture/heat exchangers, and alarms

Due to the situation of life-critical ventilators, the mechanical and functional testing must be stringent to be reliable, durable, and easy to operate under the pressurized clinical conditions, such as when protective equipment is used.

Solution

Mechanical and component testing ensure that ventilators and associated accessories withstand normal operational stresses, handling impacts, and environmental pressures. Presto Stantest’s force and torque testing solutions, developed over decades for the medical and engineering sectors, allow both established and rapidly manufactured ventilator systems to implement reliable quality checks.

Typical tests include:

• Pumps, bearings, turbines: compression, bending, and fatigue testing
• Pressure regulation valves: actuation and opening-force characterization
• Spring assemblies: compression spring rate and performance
• Touchscreen interfaces: local mechanical strength and durability
• Rotary knobs: torque and feedback response
• PCB solder joints: pull and break strength
• Crimped terminals and connectors: tensile testing
• Patient tubing: crush resistance, elongation, and recovery
• 3D-printed and composite components: mechanical integrity under load

Testing procedures are conducted with international standards and regulatory requirements. VectorPro software supports FDA 21 CFR compliance, including secure electronic records and audit trail modules for data integrity.

Test Equipment

• Force, tensile, and compression testers
• Torque testing systems
• Adjustable, quick-change grips and fixtures
• Custom 3D-printed fixtures for precise component geometry matching