Agilent 5DX Service Guide 2-9
5DX Series 3 X-ray Safety
Definition of a Cabinet X-ray System
A Cabinet X-ray System is one that produces little or no X-ray exposure to the user
and is safe to operate and to be in close proximity to under foreseeable conditions.
The 5DX System is certified to produce not more than 0.5 millirem per hour at a
distance of 5 cm from the machine surface. Agilent warrants that the 5DX System
meets all Federal Regulations regarding a Cabinet Radiography Systems.
The 5DX System is classified as a “Cabinet X-Ray System” by the United States
Code of Federal Regulations: 21 CFR 1020.40 (X-Ray) and CFR 1040.10 (Laser).
The 5DX System is designed, manufactured and registered in accordance with
strict criteria established by the Department of Health and Human Services, Food
and Drug Administration, Center for Devices and Radiological Health (CDRH),
Department of Health and Human Services (DHHS), X-ray Products Branch.
Agilent certifies that the 5DX System X-ray emissions are less than United States
Government and International Safety Standards for a “Cabinet X-ray Systems.”
Built-In Safety Features
The 5DX System is enclosed in shielding that limits X-ray exposure to normal
background levels and all of the 5DX System access ports are safety interlocked to
prevent any accidental radiation exposure. In addition, Agilent performs an X-ray
Safety Test three times on every system prior to customer use:
1. At the completion of manufacture
2. Prior to shipment from Agilent’s facility, and
3. At the user’s facility.
Agilent further warrants and certifies that the 5DX System fully passes the
approved Certification Test for compliance with 21 CFR 1020.40 after shipping
and installation at the customer's facility.
Several 5DX Systems are currently in operation throughout the world. These
systems meet local and government X-ray exposure standards.
Registration Requirements
Customers are directed to check with their state radiation control program director
for registration requirements.
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