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KMID : 1001220090110020069
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Journal of the Korean Society of Digital Medical Imaging Technology
2009 Volume.11 No. 2 p.69 ~ p.77
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General Requirements Pertaining to Radiation Protection in Diagnostic X-ray Equipment -KFDA DRS 1-1-3 : 2008 base on IEC 60601-1-3:2008- )
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Kang Hee-Doo
Dong Kyung-Rae
Kweon Dae-Cheol
Choi Jun-Gu
Jeong Jae-Ho
Jung Jae-Eun
Ryu Young-Hwan
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Abstract
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This study gives an account of the collateral standards in IEC 60601-1-3: 2008 specifying the general requirements for basic safety and essential performance of diagnostic X-ray equipment regarding radiation protection as it pertains to the production of X-rays. The collateral standards establish general requirements for safety regarding ionization radiation in diagnostic radiation systems and describe a verifiable evaluation method of suitable requirements regarding control over the lowest possible dose equivalent for patients, radiologic technologists, and others. The particular standards for each equipment can be determined by the general requirements in the collateral standard and the particular standard is followed in the risk management file. The guidelines for radiation safety of diagnostic radiation systems is written up in ISO 13485, ISO 14971, IEC 60601-1-3(2002)1st edition, medical electric equipment part 1-3, and the general requirements for safety-collateral standards: programmable electrical medical systems. Therefore the diagnostic radiation system protects citizens’ health rights with the establishment and revisions of laws and standards for diagnostic radiation systems as a background for the general requirements of radiation safe guards applies, as an international trend, standards regarding the medical radiation safety management. The diagnostic radiation system will also assure competitive power through a conforming evaluation unifying the differing standards, technical specifications, and recognized processes.
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KEYWORD
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Diagnostic X-ray equipment, Radiation protection, Collateral standard, Risk management file
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