<html xmlns="http://www.w3.org/1999/xhtml"><head><meta charset="UTF-8" /><title></title><meta name="Generator" content="PowerTools for Open XML" /><style>span { white-space: pre-wrap; } 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 xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">    </span><a href="https://sdlegislature.gov/Rules?Rule=44:03:01:08.02"><span class="sc9737353-4757-497c-ab98-b76603c444b2C0-000000">44:03:01:08.02</span></a><span xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0-000001">.  Equipment standards for medical diagnostic X ray </span><span class="sc9737353-4757-497c-ab98-b76603c444b2C0-000001">systems</span><span class="sc9737353-4757-497c-ab98-b76603c444b2C0-000001">.</span><span xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0"> </span><span 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 class="sc9737353-4757-497c-ab98-b76603c444b2C0">:</span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P0"><span xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2000002"> </span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P0"><span xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">    </span><span xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">(1)  </span><span xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">Any deviation of a measured technique factor from an indicated value of </span><span class="sc9737353-4757-497c-ab98-b76603c444b2C0">kilovoltage peak (</span><span class="sc9737353-4757-497c-ab98-b76603c444b2C0">kVp</span><span class="sc9737353-4757-497c-ab98-b76603c444b2C0">)</span><span 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 xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2000002"> </span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P0"><span xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">    (</span><span class="sc9737353-4757-497c-ab98-b76603c444b2C0">2</span><span xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">)  The tube housing assembly supports </span><span class="sc9737353-4757-497c-ab98-b76603c444b2C0">must</span><span 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 xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0"> and</span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P0"><span xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2000002"> </span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P2"><span xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">    (3)  All position locking, holding, and centering devices on the machine </span><span class="sc9737353-4757-497c-ab98-b76603c444b2C0">must</span><span 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 xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2000002"> </span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P0"><span xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">    </span><span class="sc9737353-4757-497c-ab98-b76603c444b2C0-000001">Source:</span><span xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0"> 26 SDR 96, effective January 23, 2000</span><span class="sc9737353-4757-497c-ab98-b76603c444b2C0">; 50 SDR 41, effective October 11, 2023</span><span class="sc9737353-4757-497c-ab98-b76603c444b2C0">.</span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P0"><span xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">    </span><span class="sc9737353-4757-497c-ab98-b76603c444b2C0-000001">General Authority:</span><span xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0"> SDCL </span><a href="https://sdlegislature.gov/Statutes?Statute=34-21-4.1"><span class="sc9737353-4757-497c-ab98-b76603c444b2C0-000003">34-21-4.1</span></a><span xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">, </span><a href="https://sdlegislature.gov/Statutes?Statute=34-21-15"><span class="sc9737353-4757-497c-ab98-b76603c444b2C0-000003">34-21-15</span></a><span class="sc9737353-4757-497c-ab98-b76603c444b2C0">.</span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P0"><span xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">    </span><span class="sc9737353-4757-497c-ab98-b76603c444b2C0-000001">Law Implemented:</span><span xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0"> SDCL </span><a href="https://sdlegislature.gov/Statutes?Statute=34-21-4.1"><span class="sc9737353-4757-497c-ab98-b76603c444b2C0-000003">34-21-4.1</span></a><span xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2C0">, </span><a href="https://sdlegislature.gov/Statutes?Statute=34-21-15"><span class="sc9737353-4757-497c-ab98-b76603c444b2C0-000003">34-21-15</span></a><span class="sc9737353-4757-497c-ab98-b76603c444b2C0">.</span></p><p dir="ltr" class="sc9737353-4757-497c-ab98-b76603c444b2P0"><span xml:space="preserve" class="sc9737353-4757-497c-ab98-b76603c444b2000002"> </span></p></div></body></html>