Testing medical devices in extreme conditions

In this expert blog article, we cover:

• The importance of rigorous testing of medical devices to ensure their functionality and reliability.

• Special requirements for patient ventilators due to different climatic conditions and areas of use.

• Insights into IMT's in-house test lab: equipment and capabilities to simulate extreme conditions.

• Reduced development time and cost savings through early testing during the development process.

• Integration of test results into product development for continuous improvement of medical devices.

During the development of medical devices, manufacturers often face the problem that their devices do not function as expected due to the lack of sufficient and satisfactory testing. On top of this, the users trust readings provided by measurement devices or analyzers even if the results are faulty as the devices cannot withstand the environmental conditions based on insufficient verification. Ultimately these false values on your devices may have a negative impact on patient treatment.

The testing of medical devices is an essential component during the development process and life cycle management, to meet technical and normative requirements.

Patient ventilators in particular are subject to different climatic requirements in different areas of use (for example emergency ventilators in helicopters or ventilators in hospitals respectively home care in all geographical areas of the world, whether in higher-altitude cool mountain regions or hotter close to sea-level tropical regions). These different and partly extreme conditions must be simulated and tested to guarantee the faultless functioning of a critical medical device.

Medical devices play a critical role in our modern medical landscape. It is common knowledge how important it is that these devices function faultlessly and reliably. The consequences of a faulty device can be fatal, especially for life-sustaining devices such as ventilators. Therefore, testing and ensuring the reliability of medical devices is not only desirable but essential. Therefore, verification of medical device safety and reliability is inevitable and essential, as required by numerous regulatory guidelines or standards such as (not concluding):

• IEC 60601-1 (safety requirements including essential performance characteristics)
• IEC 60601-1-2 (EMC Requirements)
• ISO 80601-2-84 (ventilators for emergency medical services environment)

Or for invitro diagnostic medical devices

• EN 61010-1 (safety requirements for electrical equipment for measurement, control and laboratory use)
• IEC 61326-1 (EMC requirements)

To fulfill the above-mentioned normative requirements, several tests must be performed.

To carry out initial tests with prototypes even during the early stages of the medical device's development, IMT uses its in-house test laboratory. The results obtained from the tests and verification accompanying the development are considered in the development process to ensure that the final tests and the resulting requirements for the medical device can be fulfilled. This reduces the development time and costs as we minimize the time required in official Test-Labs.

Our test laboratory features test equipment such as an EMV chamber (Laplace Chamber), climate chambers, IP Test (Ingress Protection) or a negative pressure chamber to test medical devices in extreme conditions which are necessary to verify the product development. Our page on testing and verification provides more information about our services and details about our in-house test laboratory.

In general, standards apply to the basic safety and essential performance of medical devices to ensure safe use. Rigorous testing is therefore essential to bring safer and compliant products into the market.

There are many standards that apply to medical devices such as medical ventilators, for example, IEC 60601-1 regarding general safety and also in particular regarding the verification of a device functionality within the range of environmental conditions; or ISO 80601-2-84 which defines for example the protection against excessive temperature in combination with humidity.

Temperature and humidity test

To verify different climatic conditions under which the medical device can be used, stored or transported, a climate chamber can be used. When testing patient ventilators, we rely on strict standards to ensure the safety and conformity of the products. Our dynamic climate chambers can mimic temperatures from -40 to +180 °C and humidity levels from 10 to 98 % RH during a defined period.

The dynamic climate chambers are available in two different sizes (115 L volume and 720 L volume) which enables testing several test devices simultaneously or putting in a complete test setup to be able to evaluate test measurements immediately during testing.

Negative pressure test

In addition to temperature and humidity testing, we also use pressure chambers to simulate different altitudes at which the medical device could be used or transported. This works as follows:

A vacuum pump regulates the pressure in the chamber until the desired value is reached. The pressure chamber in our test laboratory simulates ambient pressure up to 5000 m above sea level which equals to a pressure of nearly 540 hPa. It’s possible to generate a constant pressure over a defined period to imitate the use or storage of the medical device in defined geographical areas, e.g., La Paz at 4100 m above sea level. We can also simulate rapid pressure changes, for example to imitate the altitude change during a helicopter take-off and landing, or pressure changes over a prolonged period, for example to simulate the altitude pressure during the transport of a medical device at a long-distance flight.

In this way, it can be verified whether the full functionality of the medical device can be guaranteed when the pressure is changing or maintained.

Integrating findings into product development

The true value of our in-house test lab lies not only in the execution of the tests themselves, but also in the fast and efficient integration of the results into the development process. Each test provides valuable data that is used directly to improve and fine-tune the product. This iterative approach ensures that the final product not only meets the requirements, but in many cases exceeds them.

Reduce project time for pre-compliance testing

Thanks to our in-house test lab, we can prevent engineering tests in an expensive test laboratory where you need to wait up to 3 months or more to get a test time slot. This allows the engineering teams to reduce the development time and to book external test laboratories in a timely manner with the confidence of success.

Medical device development presents companies with enormous challenges, especially when it comes to ensuring the safety and reliability of these vital devices. IMT has recognized the need for this rigorous testing and has taken a decisive step towards quality assurance and product development with its in-house test lab.

Thanks to our well-equipped test lab, testing can be performed quickly and on short notice, which not only provides valuable results during the development process but also enables faster time-to-market. This reflects our constant pursuit of excellence and innovation and provides our customers with the assurance that their products meet the highest standards.

For anyone involved in medical device development who demands the highest standards from their products, having partners like IMT on their side is critical. If you need to test your medical device and are looking for a test lab or need customized device testing support, don't hesitate to contact our experts. We look forward to guiding you on your path to device testing and validation.