Section 144-220-N-14 - Safety criteria for productsAn applicant for a license under N.13.C. shall demonstrate that the product is designed and will be manufactured so that:
A. In normal use and disposal of a single exempt item, as defined in Part C, and in normal handling and storage of the quantities of exempt items likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, it is unlikely that the TEDE in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the product will exceed the doses in Column I of N.15.B. In use and disposal of a single exempt item and in handling and storage of the quantities of exempt items likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, the probability is low3 that the containment, shielding, or other safety features of the product would fail under such circumstances that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column II of the table in N.14 and the probability is negligible*/that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column III of the table in N.154.C. It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the product from wear and abuse likely to occur in normal handling and use of the product during its useful life. 3Low not more than one such failure per year for each 10,000 exempt units distributed. Negligible - not more than one such failure per year for each one million exempt units distributed.
4It is the intent of this paragraph that as the magnitude of the potential dose increases above that permitted under normal conditions, the probability that any individual will receive such a dose must decrease. The probabilities have been expressed in general terms to emphasize the approximate nature of the estimates which are to be made. The above values may be used as guidelines in estimating compliance with the criteria.
10-144 C.M.R. ch. 220, § N-14