Most medical devices are packaged following precise sterilization procedures. In turn, these packages, technically known as sterile barrier systems (SBS), are subject to a series of standardized climate tests that guarantee their effectiveness until the expiration date indicated on the box.
One of these is the accelerated aging test.
But let's see step by step.
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What are Sterile Barrier Systems?
As we anticipated, sterile barrier systems are the packages that ensure the sterilization of medical instruments until utilization.
Medical instruments is a very broad category and if we all immediately think of small surgical instruments such as scalpels and scissors, it also includes larger devices such as prostheses, pacemakers and diagnostic machines such as CT.
Perfect sterilization is of vital importance for many of these and the packages that guarantee it are subject to a rigorous series of tests.
The one for accelerated aging is among the most important.
How does the Accelerated Aging Test for Sterile Barrier Systems for Medical Devices work?
The protocols to be followed during the test for the accelerated aging of sterile barrier systems for medical devices are drawn up by ASTM International, a US standardization organization with international relevance.
In particular from the ASTM F1980 - 07 standard that you can download on the official website.
The accelerated aging test is intended to validate the sterile barrier system against the effects of time.
Through the controlled alteration of some environmental factors, the most important of which is temperature, an aging process of the packaging material is simulated, with or without the product inside.
It should be noted that the accelerated aging test is essential to the validation of the sterile barrier system but does not substitute the real-time aging studies which are mandatory to confirm the results of the ASTM F1980 protocol.
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The FDM Climatic Chamber for Accelerated Aging Testing of Sterile Barrier Systems
The accelerated aging test on sterile barrier systems for medical devices can be performed using the standard FDM climatic chamber.
Once the official ASTM F1980 guidelines have been acquired, performing the test using a climatic chamber is very simple and the professionalism of our machinery makes the job even more intuitive.
To find out more, here you can read the article dedicated to our accelerated aging tests in general.
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