(A) Each person licensed under rule 3701:1-46-33 of the Administrative Code shall visually inspect each device and shall reject any which has an observable physical defect that could affect containment of the tritium or promethium-147.
(B) Each person licensed under rule 3701:1-46-33 of the Administrative Code shall:
(1) Maintain quality assurance systems in the manufacture of the luminous safety device in a manner sufficient to provide reasonable assurance that the safety-related components if the distributed devices are capable of performing their intended functions; and
(2) Subject inspection lots to acceptance sampling procedures, by procedures specified in paragraph (C) of this rule and in a license issued under rule 3701:1-46-33 of the Administrative Code, to provide at least ninety five per cent confidence that the lot tolerance per cent defective of five per cent will not be exceeded.
(C) The licensee shall subject each inspection lot to:
(1) Tests that adequately take into account the individual, aggregate, and cumulative effects of the environmental conditions expected in service that could adversely affect the effective containment of tritium or promethium-147, such as absolute pressure and water immersion.
(2) Inspection for evidence of physical damage, containment failure, or for loss of tritium or promethium-147 after each stage of testing, using methods of inspection adequate for applying the following criteria for defective:
(a) A leak test resulting in a loss of 0.1 per cent or more of the original amount of tritium or promethium-147 from the device;
(b) Levels of radiation in excess of five microgray ( 0.5 millirad) per hour at ten centimeters from any surface when measured through fifty milligrams per square centimeter of absorber, if the device contains promethium-147; and
(c) Any other criteria specified in the license issued under rule 3701:1-46-33 of the Administrative Code.
(D) No person licensed under rule 3701:1-46-33 of the Administrative Code shall transfer to persons generally licensed under rule 3701:1-46-07 of the Administrative Code, or under an equivalent general license from an agreement state or the United States nuclear regulatory commission:
(1) Any luminous safety device tested and found defective under any condition of a license issued under rule 3701:1-46-33 of the Administrative Code, or paragraph (B) of this rule, unless the defective luminous safety device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or
(2) Any luminous safety device contained within any lot that has been sampled and rejected as a result of the procedures in paragraph (B)(2) of this rule, unless:
(a) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under rule 3701:1-46-33 of the Administrative Code; and
(b) Each individual sub-lot is sampled, tested, and accepted in accordance with paragraphs (B)(2) and (D)(2)(a) of this rule and any other criteria that may be required as a condition of the license issued under rule 3701:1-46-33 of the Administrative Code.