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<p class="MsoBodyText"><span lang="EN-GB">This document specifies the requirements and methods for the <em style="mso-bidi-font-style: normal;">clinical investigation</em> of <em style="mso-bidi-font-style: normal;">medical electrical (ME) equipment</em> used to measure the body temperature in <em style="mso-bidi-font-style: normal;">indirect measurement mode</em>.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document covers both intermittently and continuously measuring <em style="mso-bidi-font-style: normal;">clinical thermometers</em>.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 1<span style="mso-tab-count: 1;"> </span>This document does not apply to <em style="mso-bidi-font-style: normal;">clinical thermometers</em> measuring the body temperature in <em style="mso-bidi-font-style: normal;">direct measurement mode</em>.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 2<span style="mso-tab-count: 1;"> </span>For <em style="mso-bidi-font-style: normal;">clinical thermometers</em> in <em style="mso-bidi-font-style: normal;">direct measurement mode</em> determining the technical accuracy in accordance with ISO 80601-2-56:—</span><span lang="EN-GB">1</span><span lang="EN-GB"><span class="MsoFootnoteReference">)</span> is considered sufficient.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document is applicable to <em style="mso-bidi-font-style: normal;">clinical thermometers</em> with claimed measurement time shorter than 60 seconds (for methods such as oral or rectal measurement), or shorter than 5 minutes (for methods such as axillary measurement), and which are treated as <em style="mso-bidi-font-style: normal;">predictive type thermometers</em> and fall under the scope of this document.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document specifies additional disclosure requirements.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not apply to the <em style="mso-bidi-font-style: normal;">clinical investigation</em> of a screening thermographs for human febrile temperature screening whose <em style="mso-bidi-font-style: normal;">laboratory accuracy</em> requirements are described in IEC 80601-2-59.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not apply to pulmonary artery catheter for the determination of cardiac output by thermodilution.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 3<span style="mso-tab-count: 1;"> </span>ISO 80601-2-56:—<sup>1)</sup> does include pulmonary artery catheter for the determination of cardiac output by thermodilution.</span></p>
Reģistrācijas numurs (WIID)
85205
Darbības sfēra
<p class="MsoBodyText"><span lang="EN-GB">This document specifies the requirements and methods for the <em style="mso-bidi-font-style: normal;">clinical investigation</em> of <em style="mso-bidi-font-style: normal;">medical electrical (ME) equipment</em> used to measure the body temperature in <em style="mso-bidi-font-style: normal;">indirect measurement mode</em>.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document covers both intermittently and continuously measuring <em style="mso-bidi-font-style: normal;">clinical thermometers</em>.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 1<span style="mso-tab-count: 1;"> </span>This document does not apply to <em style="mso-bidi-font-style: normal;">clinical thermometers</em> measuring the body temperature in <em style="mso-bidi-font-style: normal;">direct measurement mode</em>.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 2<span style="mso-tab-count: 1;"> </span>For <em style="mso-bidi-font-style: normal;">clinical thermometers</em> in <em style="mso-bidi-font-style: normal;">direct measurement mode</em> determining the technical accuracy in accordance with ISO 80601-2-56:—</span><span lang="EN-GB">1</span><span lang="EN-GB"><span class="MsoFootnoteReference">)</span> is considered sufficient.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document is applicable to <em style="mso-bidi-font-style: normal;">clinical thermometers</em> with claimed measurement time shorter than 60 seconds (for methods such as oral or rectal measurement), or shorter than 5 minutes (for methods such as axillary measurement), and which are treated as <em style="mso-bidi-font-style: normal;">predictive type thermometers</em> and fall under the scope of this document.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document specifies additional disclosure requirements.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not apply to the <em style="mso-bidi-font-style: normal;">clinical investigation</em> of a screening thermographs for human febrile temperature screening whose <em style="mso-bidi-font-style: normal;">laboratory accuracy</em> requirements are described in IEC 80601-2-59.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not apply to pulmonary artery catheter for the determination of cardiac output by thermodilution.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 3<span style="mso-tab-count: 1;"> </span>ISO 80601-2-56:—<sup>1)</sup> does include pulmonary artery catheter for the determination of cardiac output by thermodilution.</span></p>
