; and (B) includes— (i) performing pre-analytical and post-analytical processes for an in vitro clinical test; (ii) conducting standard operating procedures; and (iii) preparing reagents or other test materials that do not meet the definition of a in vitro clinical test for clinical use under section 201(ss). (14) Low-risk The term low-risk , with respect to an in vitro clinical test or category of in vitro clinical tests, means that— (A) an undetected inaccurate result from such in vitro clinical test, or such category of in vitro clinical tests, when used as intended— (i) would cause minimal or no harm, or minimal or no disability, or immediately reversible harm, or would lead to only a remote risk of adverse patient impact or adverse public health impact; or (ii) could cause non-life threatening injury, harm that is medically reversible, or a delay in necessary treatment; or (B) mitigating measures are sufficient to ensure the test meets the requirements of subparagraph (A) (15) Mitigating measures The term mitigating measures — (A) means requirements that the Secretary determines, based on available evidence, are necessary— (i) for an in vitro clinical test, or a category of in vitro clinical tests, to meet the applicable standard; or (ii) to mitigate the risk of harm ensuing from an inaccurate result or misinterpretation of any result