Standard regulations overview
Disclaimer: This document provides a general overview of radiation safety and regulatory concepts in the United States (regulations vary by state). Please consult a radiation safety expert or your state radiation regulatory agency for specific requirements in your jurisdiction.
- Registration: Registering the machine/facility with appropriate regulators
- Radiation Safety Program: Maintaining a Radiation Safety Program and designating a Radiation Safety Officer (RSO)
- Personnel monitoring: Dosimetry (subject to State and Federal requirements)
- Routine maintenance: Safety checks and radiation surveys to limit risk and maintain dose As Low As Reasonably Achievable (ALARA)
- Recordkeeping: Maintaining logs/documentation of the above activities
Compliance guide
Registration
Facility registration requirements vary by location:- Most states: Allow for registration before operation or within 30 days of installation
- Some states: Require registration before the machine is installed
Radiation Safety Program
A Radiation Safety Program may include but is not limited to:- Appointing a Radiation Safety Officer (RSO)
- Personnel Radiation Safety Training
- Setting up safety precautions, postings, and emergency procedures
- Personnel monitoring (dosimetry)
- Program documentation and reporting
Personnel monitoring (dosimetry)
Each state has a section that discusses personnel monitoring and indicates an occupational dose limit for adults, a stricter limit for pregnant women, and/or a threshold at which a monitoring device is required. Typically, the occupational limit is 0.05 Sv and a dosimeter is required if personnel are expected to meet 10% of that limit. Please check your state guidelines for the exact limits. By meeting 21 CFR 1020.40, the scanner must meet the following emissions limit: radiation emission must be less than 0.5 milliroentgens per hour (5 microsieverts per hour, 5 μSv/h). Our Lumafield CT scanners are certified to emit < 1 μSv/h. With this figure in mind, the following is a sample worst-case annual dose calculation: FTE Annual Use Calculation at 5cm from Lumafield CT Scanner: [1 μSv/hour] * [40 hours/week] * [52 weeks/year] = 2,080 μSv/year Annual Exposure Limit: 0.05 Sv per year = 50 mSv/year = 50,000 μSv/year 10% of Annual Exposure Limit for Monitoring: 10% * 50,000 μSv/year = 5,000 μSv/year Under normal operating conditions, standing next to the machine for 40/hr per week still puts you under annual exposure limits.Maintenance
Annual survey: A radiation survey is required annually. This must be performed by Lumafield or a third party authorized by Lumafield. Safety checks: Safety feature testing (e.g. interlocks, X-ray indication lights) frequency is dictated by state regulations. Some states require multiple inspections a year. Lumafield includes a recommended maintenance schedule in each scanner’s user manual.Postings and recordkeeping
Postings: You must conspicuously post information including, but not limited to, the following to ensure worker safety:- Registration certificate (if applicable)
- “Notice to Employees”
- Emergency procedures
- State regulations
- Operating procedures (written operating procedures must be available to the operator; keeping the Manufacturer’s User Manual at the control panel typically satisfies this requirement)