<html xmlns="http://www.w3.org/1999/xhtml"><head><meta charset="UTF-8" /><title></title><meta name="Generator" content="PowerTools for Open XML" /><style>p.sc9737353-4757-497c-ab98-b76603c444b2P0 { margin-top: 0; margin-bottom: 0; margin-left: 0; margin-right: 0; text-indent: 0.00in; text-align: justify; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; line-height: 108%; } span.sc9737353-4757-497c-ab98-b76603c444b2C0 { color: black; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } span.sc9737353-4757-497c-ab98-b76603c444b2C0-000000 { color: #0000FF; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: bold; margin: 0; padding: 0; } span.sc9737353-4757-497c-ab98-b76603c444b2C0-000001 { color: black; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: bold; margin: 0; padding: 0; } span.sc9737353-4757-497c-ab98-b76603c444b2000002 { color: black; background: white; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } p.sc9737353-4757-497c-ab98-b76603c444b2P2 { margin-top: 0; margin-bottom: 0; margin-left: 0; margin-right: 0; text-indent: 0.00in; text-align: justify; background: white; font-family: Times; font-size: 12pt; line-height: 108%; } span.sc9737353-4757-497c-ab98-b76603c444b2C0-000003 { color: #0000FF; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } </style></head><body><div><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P0"><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">    </span><a href="https://sdlegislature.gov/Rules?Rule=44:03:01:08.02"><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0-000000">44:03:01:08.02</span></a><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0-000001">.  Equipment standards for medical diagnostic X ray </span><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0-000001">systems</span><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0-000001">.</span><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0"> </span><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0">A diagnostic X ray system must meet the specifications in 21 C.F.R. §§ 1020.30 and 1020.31, in effect on April 1, 2022. In addition, a diagnostic X ray must meet the following standards</span><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0">:</span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P0"><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2000002"> </span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P0"><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">    </span><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">(1)  </span><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">Any deviation of a measured technique factor from an indicated value of </span><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0">kilovoltage peak (</span><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0">kVp</span><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0">)</span><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0"> may not exceed any limit specified for that system by its manufacturer or, in the absence of any manufacturer's specifications, the deviation may not exceed ten percent of the indicated value for kVp;</span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P0"><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2000002"> </span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P0"><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">    (</span><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0">2</span><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">)  The tube housing assembly supports </span><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0">must</span><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0"> be adjusted so that the tube housing assembly remains stable during an exposure unless tube housing movement is a designed function of the X ray system;</span><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0"> and</span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P0"><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2000002"> </span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P2"><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">    (3)  All position locking, holding, and centering devices on the machine </span><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0">must</span><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0"> function as intended by the manufacturer.</span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P0"><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2000002"> </span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P0"><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">    </span><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0-000001">Source:</span><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0"> 26 SDR 96, effective January 23, 2000</span><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0">; 50 SDR 41, effective October 11, 2023</span><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0">.</span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P0"><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">    </span><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0-000001">General Authority:</span><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0"> SDCL </span><a href="https://sdlegislature.gov/Statutes?Statute=34-21-4.1"><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0-000003">34-21-4.1</span></a><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">, </span><a href="https://sdlegislature.gov/Statutes?Statute=34-21-15"><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0-000003">34-21-15</span></a><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0">.</span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P0"><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">    </span><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0-000001">Law Implemented:</span><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0"> SDCL </span><a href="https://sdlegislature.gov/Statutes?Statute=34-21-4.1"><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0-000003">34-21-4.1</span></a><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">, </span><a href="https://sdlegislature.gov/Statutes?Statute=34-21-15"><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0-000003">34-21-15</span></a><span style="white-space: pre-wrap;" class="sc9737353-4757-497c-ab98-b76603c444b2C0">.</span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P0"><span style="white-space: pre-wrap;" xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2000002"> </span></p></div></body></html>