3701:1-43-11. Safety criteria for consumer and retail products

An applicant for a license pursuant to paragraph (C) of rule 3701:1-43-10 of the Administrative Code, shall demonstrate that the product is designed and will be manufactured so that:

(A) In normal use and disposal of a single exempt item, 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 dose 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 the table in the appendix to this rule.

(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 low (not more than one such failure per year for each ten thousand exempt units distributed) 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 committed dose equivalent in excess of the dose to the appropriate part of the body as specified in column II of the table in the appendix to this rule and the probability is negligible (not more than one such failure per year for each one million exempt units distributed) that a person would receive an external radiation dose or committed dose equivalent in excess of the dose to the appropriate part of the body as specified in column III of the table in the appendix to this rule.

(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.

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Five Year Review (FYR) Dates: 07/11/2017 and 07/01/2022
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.01, 3748.02
Prior Effective Dates: 4/1/2012

Prior History: (Effective: 04/01/2012
R.C. 119.032 review dates: 04/01/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.01, 3748.02)