Climate tests are essential for all products and materials for which they are required by law in order to guarantee their safety and resistance.
But if there is one category in which they are literally of vital importance, it is the medical field.
In addition to the tests on medicines and cosmetics (which we have dealt with here), it is necessary to talk about the stability tests for medical devices which, as we will see, are all those other tools that doctors, in conjunction with drugs, use for the protection of our health.
What are Medical Devices
“Medical devices” is such a broad category that no list would do it justice. Suffice it to say that both an instrument such as the electrocardiograph and the surgical masks that we have all come to know due to the pandemic crisis fall right into it.
The technical definition is: "any instrument, apparatus, implant, software, substance or other product used alone or in combination with other devices or accessories, including software intended by the manufacturer to be used specifically for diagnostic or therapeutic purposes".
If it is still not clear, it can be tried with a mental operation: everything that is not a drug - ie. it does not act on the body through pharmacological or immunological means or through the metabolic process - but is aimed at protecting the health of the human body, is to be considered a medical device.
Obviously, such a large category has various divisions within it, with related international standards, which we will see in the next paragraph.
Medical Device Stability Testing Standards
The first division to operate within medical devices is that between electromedical and non-electromedical.
Instead, medical devices, in general, are covered in the ISO 13485 standard, which details the matter in general. However, there is a further distinction to be made, and that is between in vitro and non-in vitro medical devices.
By in vitro medical devices, we mean all simple or sophisticated technology devices for carrying out tests on samples taken from the human body, but also all accessories specifically intended to be used together with actual in vitro devices.
Stability Tests for Medical Devices
Given the variety of objects and products that fall under the category of medical devices, climatic tests in a climatic chamber are also extremely varied.
The stability test is the basis shared by all medical devices and mainly concerns the humidity and temperature parameters. Depending on the type of medical device, the test can be performed in a climatic chamber or in an environmental chamber and is, for example, very important for the electro-medical devices mentioned in the previous paragraph, which have very delicate electronic components that must be tested with rigour.
Many medical devices also circulate with Sterile Barrier Systems, that is the packages that guarantee the sterilization of medical instruments until the moment of use, which must be subjected to an accelerated aging test which we have discussed here.
Finally, all medical devices built with materials susceptible to corrosion, such as metals, must be subjected to the corrosion test in a climatic chamber that uses a salt spray nebulizer.
The FDM Climatic Chamber for Medical Devices
The FDM climatic chamber is the perfect tool for carrying out stability tests on medical devices and can be suitably equipped to carry out specific tests, such as the salt spray test or the solar radiation test.
All of our climatic chambers are equipped with an intuitive digital interface that guides the final operator in all stages of the process. For special needs, please do not hesitate to contact us.