Example 2: Although applying X-rays to patients is known to cause harm, the clinical effectiveness ofconventional diagnostic imaging almost always justifies its use. However, the unwanted effects of radiation onthe patient are not ignored. Standards exist to minimize unnecessary radiation exposure to patients,embodying the risk/benefit decision. When a new application of ionizing radiation to diagnostic imaging iscontemplated and existing standards are not applicable, the manufacturer should verify that the results of therisk/benefit analysis are at least as favourable as that of alternative products and treatments.