OFFICE OF FOREIGN ASSETS CONTROL

Iranian Transactions and Sanctions Regulations, 31 C.F.R. Part 560

GENERAL LICENSE 31 C.F.R. 560.530(a)(3)

Authorizing the exportation or reexportation

of medicine and medical devices to Iran

List of Medical Devices Requiring Specific Authorization 

(updated February 2, 2017)

The list below comprises the

List of Medical Devices Requiring Specific Authorization as

identified in 31 C.F.R. 560.530(a)(3)(ii)

 

General Medical Supplies and Equipment

  • Oxygen Generators
  • Pumps with flow rates of more than 1 liter/minute
  • Diagnostic Medical Imaging Equipment:

         - Gamma imaging equipment

         - Tactile Imaging equipment

         - Thermography equipment

Laboratory

  • Freeze-drying (lypophilizers) and spray-drying equipment
  • Fermenters, bioreactors, and chemostats
  • Crossflow (tangential) filtration systems and disposable filter cartridges
  • Biocontainment chambers and hoods, including isolators, biological safety cabinets, and laminar flow hoods
  • Aerosol inhalation equipment, including full-body, head-only, nose-only, and mask exposure systems
  • Decontamination showers
  • Laboratory glassware made from borosilicate glass, including reaction vessels, storage tanks, heat exchangers, and distillation and absorption columns
  • Autoclaves larger than 20 liters
  • Clinical laboratory water baths larger than 10 liters
  • Laboratory hot plates exceeding 1 square foot of heating surface
  • Freezers capable of reaching temperatures of -80 degrees Celsius
  • Laboratory shakers and incubator shakers
  • Carbon dioxide incubators
  • Circular dichroism spectrometers
  • Spectrophotometers not designed for clinical use
  • Fluorometers
  • Nuclear Magnetic Resonance Spectrometers
  • Polymerase Chain Reaction (PCR) machines
  • Differential Scanning Calorimeters
  • Chromatography Equipment
  • Fluorescence Microscopes
  • Confocal Microscopes
  • Cascade Impactors
  • Dynamic Light Scattering Equipment
  • Quasielectric Light Scattering Equipment
  • Full face mask respirators, including Powered Air Purifying Respirators (PAPR)
  • Decontamination systems using the following chemicals:

         - Vaporized hydrogen peroxide

         - Vaporized paraformaldehyde

         - Vaporized ethylene oxide

         - Isopropanol (99% purity)

  • High Efficiency Particulate Air (HEPA) Filtration Systems and HEPA filters
  • Fourier Transformation Infrared (FTIR) Systems
  • Balancing machines
  • Motion simulators
  • Rate tables
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