Numerous recommendations and regulating bodies exist regarding the safety of items such as personal protective equipment or PPE. That’s because PPE is meant to be able to protect the wearer from dangerous situations. One of those governing bodies is the Food and Drug Administration, which covers some areas of PPE, such as radioactive equipment and protective equipment against radiation.
All of this information can be found in the code of Federal Regulations (CFR) in the section under title 21. This is commonly referred to as 21 CFR and is specifically related to all the rules set forth by the FDA itself. This means it covers a lot of topics, and one of them is related to 21CFR section 1020.30, which is meant to cover everything related to radiation-based equipment, especially those that actually emit the radiation themselves.
That means there are minimum requirements that need to be met with radiation protection, such as the lead aprons that we sell on our site, which do meet those standards. In addition, they also meet the ASTM F3094-14 industry standards, which only helps further validate the protection offering.
Keep in mind that this can change at any time. Still, currently, three core areas are focused on regarding the minimal requirements for everything related to lead aprons and protection against radiation.
The first two core areas are lead equivalency and thickness. The minimum requirements for these are based on your local state recommendations and range from 0.25mm 0.50mm. In Florida, for example, the Department of Health states that to prevent the direct scatter radiation from harming staff and ancillary personnel, they must be shielded with protective aprons or whole-body protective barriers that have a minimum of 0.25 millimeter lead equivalent.
The third core area concerns labeling requirements. Everything related to radiation by the FDA must be properly labeled, including lead aprons. The information about the apron, its equivalency, compliance, model number, and type should all be on a tag attached to the apron or at least on a label that’s clearly visible and ready to be inspected. On machines themselves, it needs to be on the outside of the radiation machine, labeling it as emitting radioactive elements.
Radiation protection is a serious affair, and the bare minimum level of protection must be covered at all times according to the regulations set forth by 21CFR. This comes from scientifically backed evidence and research to help ensure protection in work environments with ionizing radiation, specifically with the professional staff that handles this type of equipment on a daily basis, as well as the patients that are exposed to the radiation.
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