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recommended actions and mitigations were taken, did not exceed RPN = 24, which is considered to be an acceptable risk when weighed against the benefits of the products. Table 1 – Risk Level Table 80 Risk Level RPN Range Definition 1 1 to 25 Negligible Risk – acceptable as implemented. 2 26 to 35 Tolerable Risk – risk verified, validated and approved through review of the design to be as low as reasonably achievable (ALARA). Additional actions may need to be taken to reduce risk to a lower level. 3 36 to 125 Intolerable Risk – unacceptable as is based on the pre-established criteria for risk acceptability; a reduction in occurrence is typically required. Biolux concludes that the Biolux LED device prototype does not contain foreseeable risks of intolerable levels. The device is designed and manufactured such that, when used as intended, it will not compromise the conditions of safety of the patients and operator, and any remaining risk is managed with a high level of protection of health and safety.PDF Image | Effect of LED Phototherapy on the Rate of Orthodontic Tooth Movement
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