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AIAT Information Explained for X-ray Equipment Installations

Posted by Trish Payne

Dec 14, 2011 4:47:00 PM

:: 2 minute read ::

AIAT Information for medical x rayThese days everyone talks in acronyms. Sometimes I have no clue what people are texting me and I practically need a guide. It just so happens that you can Google "acronym guide" and wa la, just about every possible acronym known to man can be found!... That is EXCEPT for a good explanation about the acronym AIAT which is often used in the diagnostic X-ray equipment world.  From my own search, I found results like AIAT Apple Information Access Toolkit, the AIAT Automatic Initiate, and the Automatic Track. Obviously, none of these results have anything to do with medical devices. Even the articles pertaining to the AIAT I was looking for did not include a hard and fast definition. No problem... I am more than happy to provide an explanation of exactly what AIAT means, what it is and how to obtain it.

What does AIAT mean?

Simply put AIAT means, Assemble-Install-Adjust-Test.

What is it?

AIAT is information that is provided to installers by the manufacturer in order to install 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 reference 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 very much needed and required.

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 cost of publication and distribution. Most manufacturers have set up ordering processes in their parts departments for this information. If you call with the make and model of the equipment expressing that you are looking for AIAT they should be able to locate a part number.  If you have no success with the parts division, then I recommend contacting the Compliance Manager or Quality Assurance person to see how to obtain 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 are getting much better at setting up a department to take care of these requests.

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. TFLMS my friends (translation: Thanks For Letting Me Share)! :-)

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Written by Trish Payne

author of blog post

Trish Payne is Block Imaging’s OEM and FDA Liaison. Trish is passionate about understanding the causes of challenges and working collaboratively to overcome them for the good of the imaging industry and the healthcare providers it serves. In addition to keeping Block Imaging’s work in step with industry standards, Trish is a wife, mother of two, tennis player, and world traveler.

Topics: Imaging Equipment Service, Imaging Equipment Parts, Imaging Equipment Project Management

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