TESTING AND EVALUATION FOR VENTILATORS

TESTING AND EVALUATION FOR VENTILATORS

Ventilators are used to provide breathing support to patients whom have severe respiratory condition. In the COVID-19 pandemic, there is a surge in use of ventilators in hospitals and healthcare services.  With the rising  demand, companies are venturing into producing these devices Though it is critical to meet the current needs with speed, product safety, reliability and quality should not be compromised.

Ventilators maximise airflow and expand the chest by using positive end-expiratory pressure to keep the air sacs in the lung from collapsing, thereby allowing the immune system to fight the COVID-19 infection before mucus and fluid secretions cause the lungs to fail. If the device experiences failure or the user does not adjust the volume and pressure of air correctly, the lungs can be injured with serious complications. 

HOW CAN WE HELP YOU

TÜV SÜD understands the importance of these medical devices beingsafe, functional and easy to use. Our qualified engineers are experienced to evaluate and ensure that ventilators and its accessories are safe for use in both hospitals and during home care.

Devices are put through testing for different conditions in accordance to International standards including electrical safety, simulation of various possible fault conditions, mechanical safety and biocompatibility testing among others. We work closely with our customer throughout the whole evaluation process from documentation review to the complete testing.

WHY CHOOSE TÜV SÜD

TÜV SÜD Product Service is more than just a certification and Notified Body. We are one of the healthcare sector’s most trusted brands. Our comprehensive expertise and sterling reputation have made us the world’s leading Notified Body in medical device conformity assessment, with more than 800 dedicated Medical Health and Services (MHS) experts in major markets around the globe.

By choosing TÜV SÜD, we support you throughout your product development cycle, from concept to final production. Addressing design issues during the early stages of development reduces cost and time spent on redevelopment.

Some specific tests which could be relevant for ventilators are:

• Electrical Safety (IEC 60601-1)
• Electromagnetic Compatibility (IEC 60601-1-2)
• Usability and Software Evaluation (IEC 60601-1-6, IEC 62366)
• Medical Device Software (IEC 62304)
• Acoustic Test for Alarm (IEC 60601-1-8)
• Risk Management (ISO 14971)
• Biocompatibility (ISO 10993)
• Transportation and Packaging Tests (ASTM and ISTA)
• Performance and customised testing
• Others

Represented in over 1,000 locations worldwide, TÜV SÜD has an unsurpassed track record of meeting expectations of our client companies. The TÜV SÜD brand and our distinctive blue octagon mark are instantly recognised around the globe as symbols of quality and safety, and will increase customer confidence in your brand