If you've read somewhere, heard somewhere, or been told by someone that you need to get AIAT information for your medical imaging equipment, we're willing to bet your first response was, "Huh?" That's okay! You're certainly not alone (we get questions about it all the time) and you've come to the right place to have those initials decoded.
In the next few paragraphs, or in the video version (you TLDR types can just scroll down a bit), we'll give you the basics on AIAT: What it is, why you need it, and where you can get it.
What Does AIAT Mean?
Simply put, AIAT stands for, Assemble-Install-Adjust-Test.
What Is It?
AIAT is information that is provided to owners and installers by the manufacturer in order to assemble, install, adjust, and test X-ray equipment properly. This information is very important to installing vendors because it is an FDA requirement. The 2579 Forms that are required to be filled out upon installation contain this statement which references use of AIAT information:
I affirm that all certified components assembled or installed by me, for which this report is being made, were adjusted and tested by me according to the instructions provided by the manufacturer, were of the type required by the manufacturer, were of the type required by the diagnostic X-ray performance standard (21 CFR 1020.30) were not modified to adversely affect performance and were installed in accordance with provisions of 21 CFR 1020.
So, you can see that this information is priceless to vendors who install equipment and is legally required of the OEM per the FDA.
How Do I Get AIAT Information?
The manufacturer is required to provide AIAT information to you “at cost”. At cost means that the information should be provided at a cost not to exceed the expense of publication and distribution. Most manufacturers have AIAT information posted on their websites. Some companies make it freely available, while others require users to call them for a login ID.
If digital copies are not available, another common alternative is to order physical copies through the OEM's parts department. If you call with the make, model, and serial number of the equipment, expressing that you are looking for AIAT, there should be a part number for the documents.
If you have no success with the parts division, we recommend contacting the Compliance Manager or Quality Assurance Officer for it. Usually, this person can be found on the company website and emailed. Sometimes it is difficult to figure out who to contact, but manufacturers have improved over the years in making AIAT information easier to access.
If you have questions or need help, feel free to send me a message and together we will see what we can do. I hope that I have helped you to better understand what AIAT is.