X-Ray Equipment Audit

Recurrent Homologation Audits of X-Ray Equipment

Ionizing radiation is potentially dangerous for patients and doctors. To keep radiation doses at the lowest levels possible, X-ray equipment is checked on a regular basis - before initial operation, at least every five years, and following significant adjustments. We inspect the benchmark return of your devices during constancy tests, can assume management of your audit deadlines on your behalf, and carry out specialized tests on computer tomography, heart catheter measuring systems, and non-medical X-ray equipment used for industry, research, and development.

Benefits at a Glance

With TÜV Rheinland as your partner for radiation protection in radiology you:

  • Guarantee your patients and users precise diagnoses, technical quality, and safe use of your X-ray technology
  • Fulfill operator responsibilities and get legal peace of mind concerning X-ray and radiation protection directives
  • Never again miss an audit deadline
  • Quickly have your X-ray equipment back in operation and according to legal requirements
  • Benefit from our extensive experience and independent authority during result determination
  • Take advantage of our one-stop-shop services - we can tie in further auditing services with your unique safety package
  • Choose an authorized, customer-friendly comprehensive service provider - of particular interest for larger clinics and chains
  • Quickly implement investments in X-ray technology

Our Range of Services

  • Notification or authorization procedure based on X-ray directives (§§ 3 and 4 of the Röntgenverordnung (RöV))
  • Recommisioning of X-ray systems
  • Expert reports on construction, person, device, switching, and operator radiation protection based on guidelines for technical audits of X-ray systems and radiation sources requiring authorization (SV-RL)
  • Inspection following significant adjustments to X-ray systems or required systems for X-ray use (based on § 4 of paragraph 5 of RöV)
  • Recurrent expert audits every 5 years (based on § 18.4 of RöV)
  • Documentation of the expert report based on SV-RL
  • Month and year labeling of the next repeat audit with barcode test plates
  • Audit deadline management
  • Specialized auditing of almost all devices on the market, including computer tomography, heart catheter measuring systems, and non-medical X-ray systems used for industry, research, and development
  • Radiation protection planning, structural radiation protection prior to initial operation
  • Metrological tests (MTK) at dose area product measurement systems
  • Monitor display tests
  • X-ray viewing apparatus checks
  • Foil cassette stock check for:
    • Consistency of amplification factor
    • Surface pressure of foil on film
    • Artifacts

Statutory Basics

  • Atomic laws
  • X-ray directive (Röntgenverordnung, RöV)
  • Radiation directive (Strahlenschutzverordnung, StrSchV)
  • Guidelines for X-ray system technical audits (SV-RL)
  • Medical devices regulations (Medizinproduktegesetz, MPG)