Safety Criteria

Safety Criteria. An applicant for a license under 1.11.15(2) shall demonstrate that the product is designed and will be manufactured so that: 1. In normal use and disposal, it is unlikely that the external radiation dose in any one year, or the dose commitment resulting from the intake of NORM, excluding radon and radon decay products, in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or NORM from the material or product, will exceed the doses in Column I of 1.11.17 2. In normal handling and storage of the quantities of the material or product likely to accumulate in one location during marketing, distribution, installation, and servicing of the material or product, it is unlikely that the external radiation dose in any one year, or the dose commitment resulting from the intake of NORM, excluding radon, in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or NORM from the material or product, will exceed the doses in Column II of 1.11.17 3. In normal use, disposal, handling, and storage, it is unlikely that the radon released from the material or product will result in an increase in the average concentration in air of more than 0.4 picocurie per liter (14.8Bq/m3). 4. It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the material or product from wear and abuse likely to occur in normal handling and use of the material or product during its useful life. Table of Organ Doses. Column I* Column II* Part of Body Dose in Rem Dose in Rem Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye 0.005 (0.05 mSv) 0.5 (5 mSv) Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter 0.075 (0.75 mSv) 7.5 (75 mSv) Other organs 0.015 (0.15 mSv) 1.5 (15 mSv) *Dose limit is the dose above background from the product.