<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.s5487a26d-d59a-42f8-b7f9-de47c8fbc34fP0 { 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.s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0 { color: black; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } span.s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0-000000 { color: #0000FF; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: bold; margin: 0; padding: 0; } span.s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0-000001 { color: black; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: bold; margin: 0; padding: 0; } span.s5487a26d-d59a-42f8-b7f9-de47c8fbc34f000002 { color: black; background: white; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } span.s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0-000003 { 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="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fP0"><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">    </span><a href="https://sdlegislature.gov/Rules?Rule=44:03:01:08.08"><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0-000000">44:03:01:08.08</span></a><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0-000001">.  Equipment standards for computed tomography systems.</span><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0"> </span><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">A</span><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0"> computed tomography </span><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">(CT) system must meet the specifications in 21 C.F.R. §§ 1020.30 and 1020.33, in effect on April 1, 2022. In addition, a CT system must meet the following standards</span><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">:</span></p><p dir="ltr" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fP0"><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34f000002"> </span></p><p dir="ltr" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fP0"><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">    (1</span><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">)  </span><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">The system must provide for two-way</span><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">,</span><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0"> oral communication between the patient and the operator at the control panel;</span></p><p dir="ltr" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fP0"><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34f000002"> </span></p><p dir="ltr" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fP0"><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">    (</span><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">2</span><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">)  Leaded windows, mirrors, </span><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">a </span><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">closed-circuit television, or an equivalent </span><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">must</span><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0"> be </span><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">located</span><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0"> to permit </span><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">the operator to continuously observe</span><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0"> the patient during irradiation from the control panel;</span><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0"> and</span></p><p dir="ltr" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fP0"><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34f000002"> </span></p><p dir="ltr" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fP0"><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">    (</span><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">3</span><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">)  If the primary viewing system is by electronic means, an alternate viewing system, which may be electronic, </span><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">must</span><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0"> be available for use </span><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">if</span><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0"> the primary viewing system</span><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0"> fails</span><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">.</span></p><p dir="ltr" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fP0"><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34f000002"> </span></p><p dir="ltr" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fP0"><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">    </span><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0-000001">Source:</span><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0"> 26 SDR 96, effective January 23, 2000</span><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">; 50 SDR 41, effective October 11, 2023</span><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">.</span></p><p dir="ltr" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fP0"><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">    </span><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0-000001">General Authority:</span><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0"> SDCL </span><a href="https://sdlegislature.gov/Statutes?Statute=34-21-4.1"><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0-000003">34-21-4.1</span></a><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">, </span><a href="https://sdlegislature.gov/Statutes?Statute=34-21-15"><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0-000003">34-21-15</span></a><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">.</span></p><p dir="ltr" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fP0"><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">    </span><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0-000001">Law Implemented:</span><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0"> SDCL </span><a href="https://sdlegislature.gov/Statutes?Statute=34-21-4.1"><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0-000003">34-21-4.1</span></a><span class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fC0">.</span></p><p dir="ltr" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34fP0"><span xml:space="preserve" class="s5487a26d-d59a-42f8-b7f9-de47c8fbc34f000002"> </span></p></div></body></html>