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Performance Standard Requirements for Fluoroscopic X-Ray Systems: Timing, Safety Features and Display Requirements

This guidance clarifies FDA's interpretation of specific performance standard requirements for fluoroscopic equipment under 21 CFR 1020.30 and 1020.32. It applies to image-intensified fluoroscopic x-ray systems, both stationary and mobile, classified under 21 CFR 892.1650, including interventional fluoroscopic systems.

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By ReguVirta
3 min read

What You Need to Know? 👇

What is the FDA’s interpretation of fluoroscopic irradiation time under 21 CFR 1020.30(b)?

FDA interprets fluoroscopic irradiation time as the cumulative duration of operator-applied continuous pressure on the fluoroscopy control, regardless of whether fluoroscopy operates in pulsed or continuous mode, or pulse width and rate.

Which fluoroscopic equipment types are covered by this FDA guidance document?

The guidance covers image-intensified fluoroscopic x-ray systems classified under 21 CFR 892.1650, including stationary and mobile systems with product codes JAA, OWB, and OXO. Angiographic x-ray systems are excluded.

What are the FDA’s compliance requirements for fluoroscopy exposure termination after operator pressure release?

For exposures over 0.5 seconds, termination must occur within 0.1 seconds of pressure release. For exposures of 0.5 seconds or less, termination must occur within 0.5 seconds of pressure release.

When can fluoroscopic equipment operate without meeting standard display requirements under 21 CFR 1020.32?

During emergency fluoroscopy mode following equipment malfunction, FDA won’t enforce display requirements of 21 CFR 1020.32(f), (h), (j), and (k), provided recovery to normal operation occurs within 10 minutes when possible.

What is the purpose of last-image-hold functionality in fluoroscopic equipment?

Last-image-hold displays the final image after fluoroscopic exposure termination for review, consultation, or education purposes, potentially eliminating the need for additional radiation exposure and reducing patient dose if image quality is adequate.

How does this guidance align with international standards for fluoroscopic equipment?

The guidance aligns with IEC standards 60601-2-43 and 60601-2-54, particularly regarding irradiation event definitions, exposure termination timing, and emergency fluoroscopy mode considerations for interventional procedures.

What You Need to Do 👇

  1. Implement fluoroscopic irradiation time display according to FDA’s interpretation
  2. Ensure last-image-hold feature meets timing requirements for exposure termination
  3. Design emergency fluoroscopy mode with recovery capabilities within 10 minutes
  4. Verify all required displays are functioning in normal operation mode
  5. Document compliance with exposure termination timing requirements
  6. Implement continuous pressure control mechanisms for fluoroscopic exposure
  7. Ensure all safety features and displays are properly integrated into the system
  8. Develop procedures for emergency fluoroscopy mode operation and recovery

Key Considerations

Software

  • Emergency fluoroscopy mode should provide automatic or manual recovery methods within 10 minutes
  • Last-image-hold feature must be available following termination of fluoroscopic exposure

Labelling

  • Display of fluoroscopic irradiation time at fluoroscopist’s working position
  • Display of x-ray tube potential and current, air kerma rate and cumulative air kerma

Safety

  • Continuous pressure required by operator for fluoroscopic exposure
  • Exposure must terminate within 0.1 sec of release for exposures >0.5 sec
  • Exposure must terminate within 0.5 sec of release for exposures ≤0.5 sec
  • Emergency fluoroscopy mode allowed during equipment malfunction for interventional procedures

Other considerations

  • Fluoroscopic irradiation time is cumulative duration of operator-applied continuous pressure
  • Last-image-hold quality should be adequate to avoid additional radiation exposure

Relevant Guidances 🔗

Related references and norms 📂

  • IEC 60601-2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
  • IEC 60601-2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
  • IEC 61910-1:2014: Radiation dose documentation – Part 1: Radiation dose structured reports for radiography and radioscopy
  • IEC 60601-1-3:2008/AMD1:2013: General requirements for basic safety and essential performance – Collateral standard: Radiation protection in diagnostic X-ray equipment

Original guidance

  • Performance Standard Requirements for Fluoroscopic X-Ray Systems: Timing, Safety Features and Display Requirements
  • HTML / PDF
  • Issue date: 2019-05-08
  • Last changed date: 2019-05-07
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Radiological Health
  • ReguVirta ID: 337fe152d7a7baf946f369475f4ba91a
FDA guidance, Final
Medical Devices Radiation-Emitting Products Radiological Health
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