Internationally, radiation safety standards are provided by the International Electrotechnical Commission (IEC) in its collateral standard 6.
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Diagnostic x-ray equipment manufactured for the US market must meet the performance requirements described in Title 21 of the Code of Federal Regulations, sections 1020.30 through 1020.33, which require manufacturers to provide users with operational and safety information as well as to meet standards for equipment performance. In general, there are a number of regulations, consensus safety standards, and radiation protection guidelines governing the performance and use of diagnostic x-ray equipment. The intent of this guidance is to advise manufacturers and FDA staff about safety procedures and recommendations that should be provided to the end user to promote safe use of hand-held x-ray equipment. Guidance for Industry and FDA Staff Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use Introduction Please use the document number (1680) to identify the guidance you are requesting. You may also send an e-mail request to to receive a copy of the guidance. Additional CopiesĪdditional copies are available from the Internet. Comments may not be acted upon by the Agency until the document is next revised or updated. When submitting comments, please refer to the exact title of this guidance document. Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. Office of Communication, Education, and Radiation ProgramsĬontains Nonbinding Recommendations Preface Public Comment Department of Health and Human ServicesĬenter for Devices and Radiological Healthĭivision of Mammography Quality and Radiation Programs Center for Devices and Radiological Health, Office of Product Evaluation and Quality, Office of In Vitro Diagnostics and Radiological Healthįor questions regarding this document contact CDR Sean Boyd at 30.