Rationale

D8037 was balloted for re-approval on ballot D18(23-01) and there was one negative voter that was found non-persuasive on Ballot D18(323-05) The successful non-persuasive ballot for the negative vote on Ballot D18 (23-05) was appealed to the Committee on Standards (COS). During its review in March of 2024 the COS determined that a footnote must be added to the standard clarifying there was a sole source of supply. The COS also determined on some other ballot items that reference to the manufacturers SOPs are not desirable. The required footnote has been added and the reference to the SOP has been replaced with a peer review citation as highlighted in section 5.2. These changes required the item to be balloted as a revision and permission was granted to ballot concurrently.