For the safety of the patient, the development of any new pulse oximeter equipment requires calibration and evaluation for accuracy. This is required to ensure that the pulse oximeter device is functional. Results of accuracy evaluations have to be reported so the clinician is informed and he/she can understand the limits of the device that he/she is using. The International Organization for Standardization (ISO) and a technical committee have created standards that regulate the calibration and accuracy evaluation procedures of pulse oximeters. These standards are enforced by regulatory bodies, such as the federal drug administration (FDA), to approve the medical device for its use.