ISO/TC 121/SC 3

Project No.ISO/DIS 12487
Title<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none; margin: 0cm 0cm 6.0pt 0cm;"><span lang="EN-GB" style="font-size: 11.0pt;">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;">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" style="mso-layout-grid-align: none; text-autospace: none; margin: 0cm 0cm 6.0pt 0cm;"><span lang="EN-GB" style="font-size: 11.0pt;">This document covers both intermittently and continuously measuring </span><em style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="font-size: 11.0pt; mso-fareast-language: JA;">clinical thermometers</span></em><span lang="EN-GB" style="font-size: 11.0pt; mso-fareast-language: JA;">.</span></p> <p class="Note" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB">NOTE</span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;"><span style="mso-tab-count: 1;">           </span>For </span><em style="mso-bidi-font-style: normal;"><span style="mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast; mso-ansi-language: EN-US; mso-fareast-language: DE;">clinical thermometers</span></em><span style="mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast; mso-ansi-language: EN-US; mso-fareast-language: DE;"> in <em style="mso-bidi-font-style: normal;">direct measurement mode</em> determining the technical accuracy in accordance with IEC 80601-2-56 is typically sufficient</span><span lang="EN-GB" style="mso-fareast-language: JA;">.</span></p> <p class="Note" style="margin-bottom: 6.0pt; tab-stops: 19.85pt 39.7pt 48.0pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="font-size: 11.0pt;">This document specifies additional disclosure requirements.</span></p> <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none; margin: 0cm 0cm 6.0pt 0cm;"><span lang="EN-GB" style="font-size: 11.0pt;">This document is not applicable to the </span><em style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="font-size: 11.0pt; mso-bidi-font-size: 10.0pt;">clinical investigation</span></em><span lang="EN-GB" style="font-size: 11.0pt;"> of a screening thermographs for human febrile temperature screening</span> <span lang="EN-GB" style="font-size: 11.0pt;">whose <em style="mso-bidi-font-style: normal;">laboratory accuracy</em> requirements are described in IEC 80601-2-59.</span></p>
Registration number (WIID)85205
Scope<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none; margin: 0cm 0cm 6.0pt 0cm;"><span lang="EN-GB" style="font-size: 11.0pt;">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;">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" style="mso-layout-grid-align: none; text-autospace: none; margin: 0cm 0cm 6.0pt 0cm;"><span lang="EN-GB" style="font-size: 11.0pt;">This document covers both intermittently and continuously measuring </span><em style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="font-size: 11.0pt; mso-fareast-language: JA;">clinical thermometers</span></em><span lang="EN-GB" style="font-size: 11.0pt; mso-fareast-language: JA;">.</span></p> <p class="Note" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB">NOTE</span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;"><span style="mso-tab-count: 1;">           </span>For </span><em style="mso-bidi-font-style: normal;"><span style="mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast; mso-ansi-language: EN-US; mso-fareast-language: DE;">clinical thermometers</span></em><span style="mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast; mso-ansi-language: EN-US; mso-fareast-language: DE;"> in <em style="mso-bidi-font-style: normal;">direct measurement mode</em> determining the technical accuracy in accordance with IEC 80601-2-56 is typically sufficient</span><span lang="EN-GB" style="mso-fareast-language: JA;">.</span></p> <p class="Note" style="margin-bottom: 6.0pt; tab-stops: 19.85pt 39.7pt 48.0pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="font-size: 11.0pt;">This document specifies additional disclosure requirements.</span></p> <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none; margin: 0cm 0cm 6.0pt 0cm;"><span lang="EN-GB" style="font-size: 11.0pt;">This document is not applicable to the </span><em style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="font-size: 11.0pt; mso-bidi-font-size: 10.0pt;">clinical investigation</span></em><span lang="EN-GB" style="font-size: 11.0pt;"> of a screening thermographs for human febrile temperature screening</span> <span lang="EN-GB" style="font-size: 11.0pt;">whose <em style="mso-bidi-font-style: normal;">laboratory accuracy</em> requirements are described in IEC 80601-2-59.</span></p>
StatusAptauja slēgta
ICS group11.040.55