Environmental simulation for medical devices
Why they are indispensable
In medical technology, the safety and reliability of products is paramount. Medical devices must function flawlessly at every stage of their life cycle – from transport and storage to use on patients. This article sheds light on why environmental simulations are essential for medical devices and how they contribute to the safety and effectiveness of products.
The importance of environmental simulations for medical devices
Medical devices are an essential part of modern healthcare and are often the last line of defence when it comes to protecting and improving people’s lives. From simple diagnostic devices to life-saving implants, each of these products must be able to function reliably even under the most adverse conditions.
Environmental simulations play a crucial role in ensuring the robustness of these devices. Through tests that simulate extreme conditions such as heat, cold, humidity, vibration and shock, manufacturers can ensure that their products are ready for use under all circumstances. These tests are not only a technical necessity, but also a legal requirement to ensure that products comply with strict international standards and regulations.
The path of a medical device through to use on patients
The life cycle of a medical device can be divided into three main phases: Transport, storage and use. Each of these phases brings with it specific challenges that need to be addressed through targeted environmental simulations.
Transport phase
During the transport phase, medical devices are exposed to a variety of mechanical stresses. Pressure differences during air transport, strong vibrations during road transport or sudden shocks are just some of the challenges that these devices have to face.
Why this is important: A medical device that is damaged during transport can lose its functionality before it even reaches the patient. This is where shock and vibration tests come into play. These tests simulate the transport conditions and help to identify and rectify weak points before they become a real problem.
Storage phase
The storage phase of a medical device can last months or even years. During this time, climatic conditions such as high temperatures, extreme cold or high humidity can significantly affect the materials and electronics of a product.
Practical example: Imagine a ventilator is stored in a tropical climate where the humidity is constantly high. Without appropriate testing, the device’s electronics could be affected by corrosion, which in the worst case could lead to failure when it is needed.
Storage scenarios can be realistically simulated and tested in special climate chambers to ensure that the products continue to function properly even after long periods of storage.
Application phase
The application phase is the most important phase in the life of a medical device. This is when it is actually used on patients, often under unpredictable and challenging conditions.
Why this matters: Medical devices need to be able to function in a wide range of conditions – be it in an air-conditioned environment, in an operating theatre, in an ambulance at -20 °C or at +40 °C under blazing sun. Environmental simulations help to ensure that these devices work reliably even under extreme conditions, which can ultimately save lives.
Relevance of environmental simulations in relation to medical devices
Environmental simulations are essential to ensure the safety and reliability of medical devices. They help to identify and minimise potential risks at an early stage before the product is released into the real world. For manufacturers, this not only means greater safety and confidence, but also compliance with the strict regulatory requirements that are essential in medical technology.
A practical example: a medical data logger system installed in an emergency helicopter must not only record data reliably, but also function perfectly under extreme conditions such as strong vibrations and rapid temperature changes. Environmental simulations can ensure that this system works reliably even in such extreme situations, guaranteeing data integrity and ultimately patient safety.
Our services
At Enveon, we specialise in ensuring the robustness and reliability of medical devices through comprehensive environmental simulation testing. Our state-of-the-art shakers, climate and temperature chambers allow us to accurately simulate a variety of environmental conditions to ensure that your products perform reliably under all conditions.
What sets us apart: Our ability to respond flexibly to our customers’ specific requirements makes us a valuable partner in medical technology. We understand the unique challenges manufacturers face and offer customised solutions to ensure your products meet the highest standards.
Get in touch with us
If you have any questions about environmental simulation testing in relation to medical devices or need assistance with testing your products, please do not hesitate to contact us. Our team will be happy to answer any questions you may have and help you choose the right tests.
