Bush__The_Essential_Physics_for_Medical_Imaging - Biomedical ...

clides are the "Standards for Protection Against Radiation" (Part 20) and "MedicalUse of By-Product Material" (Part 35). Part 20 contains the definitions utilized inthe radiation control regulations and requirements for radiation surveys; personnelmonitoring (dosimetry and bioassay); radiation warning signs and symbols; andshipment, receipt, control, storage, and disposal of radioactive material. Part 20 alsospecifies the maximal permissible doses to radiation workers and the public; environmentalrelease limits; and documentation and notification requirements after asignificant radiation accident or event, such as the loss of a brachytherapy source orthe release of a large quantity of radioactive material to the environment.Part 35 lists the requirements for the medical use of by-product material. Someof the issues covered in this section include the medical use categories, trainingrequirements, precautions to be followed in the medical use of radiopharmaceuticals,testing and use of dose calibrators, and requirements for the reporting of medicalevents (misadministrations) of radiopharmaceuticals. The NRC also issues regulatoryguidance documents, which provide the licensee with methods acceptableto NRC for satisfYing the regulations. The procedures listed in these documentsmay be adopted completely or in part with the licensee's own procedures, which willbe subject to NRC review and approval.The FDA regulates radiopharmaceutical development and manufacturing aswell as the performance and radiation safety requirements associated with the productionof commercial x-ray equipment. Although this agency does not directlyregulate the end user (except for mammography), it does maintain a strong involvementin both the technical and regulatory aspects of human research with radioactivematerials and other radiation sources as well as publish documents in areas ofinterest including radiologic health, design and use of x-ray machines, and radiopharmaceuticaldevelopment.The U.S. Department of Transportation (DOT) regulates the transportation ofradioactive materials. Other regulations and recommendations related to medicalradiation use programs are promulgated by other federal, state, and local agencies.Several advisory organizations exist that periodically review the scientific literatureand issue recommendations regarding various aspects of radiation protection. Whiletheir recommendations do not constitute regulations and thus do not carry the forceof law, they are usually the origin of the most of the regulations adopted by regulatoryagencies and are widely recognized as "standards of good practice." Many ofthese recommendations are voluntarily adopted by the medical community even inthe absence of a specific legal requirement. The two most widely recognized advisorybodies are the National Council on Radiation Protection and Measurements(NCRP) and the International Commission on Radiological Protection (ICRP). TheNCRP is a nonprofit corporation chartered by Congress to collect, analyze, develop,and disseminate, in the public interest, information and recommendations aboutradiation protection, radiation measurements, quantities, and units. In addition, it ischarged with working to stimulate cooperation and effective utilization of resourcesregarding radiation protection with other organizations including the ICRP.The ICRP is similar in scope to the NCRP; however, its international membershipbrings to bear a variety of perspectives on radiation health issues. TheNCRP and ICRP have published over 200 monographs containing recommenda-