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Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards

This guidance addresses diagnostic x-ray imaging systems and their major components that are classified as Class I or II medical devices. It aims to harmonize FDA's EPRC (Electronic Product Radiation Control) performance standards with IEC standards to ensure efficient and consistent regulatory review of these products. The guidance covers various x-ray imaging devices including radiographic, fluoroscopic, mammographic, dental, and computed tomography systems.

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By ReguVirta
4 min read

What You Need to Know? 👇

What IEC standards can replace EPRC performance standards for medical X-ray devices?

FDA recognizes eight IEC 60601 series standards that can replace certain EPRC requirements, including IEC 60601-1-3 for radiation protection, IEC 60601-2-28 for X-ray tubes, and device-specific standards for CT, mammography, fluoroscopy, and dental equipment.

Which EPRC requirements cannot be met through IEC standard conformance?

Records and reports (21 CFR 1002), identification requirements (21 CFR 1010.3), assemblers’ responsibilities (21 CFR 1020.30(d)), warning labels, and certain fluoroscopic equipment specifications like lateral plane patient entrance point cannot be satisfied solely through IEC conformance.

How should manufacturers certify products conforming to IEC standards instead of EPRC?

The certification label must include a modified compliance statement referencing both the applicable CFR sections and the specific IEC standard with edition number, publication date, and any corrigenda or amendments, following the format provided in the guidance.

What documentation must be provided to assemblers when using IEC standards?

Manufacturers must provide a Radiation Safety Specification and Testing Comparison Document that includes radiation safety specifications, applicable IEC clauses, corresponding EPRC requirements being replaced, and test methods with acceptance criteria for assembly and installation.

Do hybrid imaging devices fall under this IEC conformance policy?

Yes, for hybrid devices like PET/CT systems, the policy applies to any component that has an applicable EPRC standard. For example, the CT component would need to conform to relevant IEC standards while other components follow their respective requirements.

What happens if a device fails to meet declared IEC standard requirements?

Failure to meet any IEC standard requirement constitutes an electronic product defect requiring notification to FDA under 21 CFR 1003.10 and potential repurchase, repair, or replacement under an FDA-approved corrective action plan per 21 CFR Part 1004.

What You Need to Do 👇

  1. Determine applicable IEC standards for your specific device type using the guidance’s appendix
  2. Implement testing program to demonstrate conformance with applicable IEC standards
  3. Prepare and maintain declaration of conformity documentation
  4. Create and affix appropriate certification label
  5. Develop and provide AIAT documentation including Radiation Safety Specification and Testing Comparison Document
  6. Establish quality system procedures for:
    • Design controls
    • Testing documentation
    • Records maintenance
    • Defect reporting and correction
  7. Implement procedures for:
    • Accidental radiation occurrence reporting
    • Defect notification
    • Corrective actions
  8. Ensure compliance with both medical device and electronic product regulations
  9. Maintain all required documentation and records for FDA inspection
  10. Provide necessary information to assemblers and other personnel

Key Considerations

Non-clinical testing

  • Testing must be based upon individual article testing or testing program in accordance with good manufacturing practice
  • Testing results must be documented and placed in firm’s records
  • Quality system must address radiation safety and conformity through design controls

Labelling

  • Certification label must be permanently affixed and legible
  • Label must be in English language
  • Must include modified statement of compliance with specific IEC standards
  • Must provide instructions for assembly, installation, adjustment and testing (AIAT)
  • Must include Radiation Safety Specification and Testing Comparison Document

Safety

  • Must comply with radiation safety specifications
  • Must provide protection from hazardous and unnecessary radiation exposure
  • Must maintain records of accidental radiation occurrences
  • Must notify FDA of radiation safety defects
  • Must implement corrective actions for defects

Other considerations

  • Manufacturers must provide certifications for their products
  • Must maintain quality system records
  • Must provide information to assemblers and others
  • Must comply with both medical device and electronic product regulations

Relevant Guidances 🔗

Related references and norms 📂

  • IEC 60601-1-3: Medical electrical equipment – Collateral Standard: Radiation protection in diagnostic X-ray equipment
  • IEC 60601-2-28: Medical electrical equipment - Particular requirements for X-ray tube assemblies
  • IEC 60601-2-43: Medical electrical equipment – Particular requirements for X-ray equipment for interventional procedures
  • IEC 60601-2-44: Medical electrical equipment – Particular requirements for X-ray equipment for computed tomography
  • IEC 60601-2-45: Medical electrical equipment – Particular requirements for mammographic X-ray equipment
  • IEC 60601-2-54: Medical electrical equipment – Particular requirements for X-ray equipment for radiography and radioscopy
  • IEC 60601-2-63: Medical electrical equipment – Particular requirements for dental extra-oral X-ray equipment
  • IEC 60601-2-65: Medical electrical equipment – Particular requirements for dental intra-oral X-ray equipment

Original guidance

  • Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards
  • HTML / PDF
  • Issue date: 2023-02-21
  • Last changed date: 2023-02-21
  • Status: FINAL
  • Official FDA topics: Radiation-Emitting Products, Medical Devices, 510(k), Premarket, Radiological Health, Radiology
  • ReguVirta ID: 58e070c0b8a3464b286ec2b5345b4b1b
FDA guidance, Final
Radiation-Emitting Products Medical Devices 510(k) Premarket Radiological Health Radiology
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