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Projekta Nr. ISO 81060-3:2022 Nosaukums <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">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;">continuous automated non-invasive sphygmomanometers</em> used for the measurement of the <em style="mso-bidi-font-style: normal;">blood pressure</em> of a patient.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document does not cover usability aspects such as the form and manner of the data display or output. This document does not specify a numerical threshold on the <em style="mso-bidi-font-style: normal;">minimum output period</em>. A <em style="mso-bidi-font-style: normal;">continuous automated non-invasive sphygmomanometer</em> providing <em style="mso-bidi-font-style: normal;">blood pressure</em> parameters (e.g., <em style="mso-bidi-font-style: normal;">systolic blood pressure</em>, <em style="mso-bidi-font-style: normal;">diastolic blood pressure</em> or <em style="mso-bidi-font-style: normal;">mean arterial pressure</em>) with an <em style="mso-bidi-font-style: normal;">output period</em> considerably larger than 30 s is not typically considered a <em style="mso-bidi-font-style: normal;">continuous automated non-invasive sphygmomanometer</em>.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document covers both trending <em style="mso-bidi-font-style: normal;">continuous automated non-invasive sphygmomanometers</em> and absolute accuracy <em style="mso-bidi-font-style: normal;">continuous automated non-invasive sphygmomanometers</em> and focuses solely on requirements for the <em style="mso-bidi-font-style: normal;">clinical investigation</em>. Representation of output is not covered by this document.</span></p>
<p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 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="mso-bidi-font-size: 12.0pt;">NOTE 1<span style="mso-tab-count: 1;"> </span><span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">IEC</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">62366</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">1</span></span></span> provides requirements on the application of usability engineering to medical devices. The usability engineering <em style="mso-bidi-font-style: normal;">process</em> can be used to clarify for the intended user whether the displayed data concerns absolute accurate values or trending values.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">The requirements and methods for the <em style="mso-bidi-font-style: normal;">clinical investigation</em> of <em style="mso-bidi-font-style: normal;">continuous automated non-invasive sphygmomanometers</em> provided in this document are applicable to any subject population, and any condition of use of the <em style="mso-bidi-font-style: normal;">continuous automated non-invasive sphygmomanometers</em>.</span></p>
<p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 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="mso-bidi-font-size: 12.0pt;">NOTE 2<span style="mso-tab-count: 1;"> </span>Subject populations can, for example, be represented by age or weight ranges.</span></p>
<p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 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="mso-bidi-font-size: 12.0pt;">NOTE 3<span style="mso-tab-count: 1;"> </span>This document does not provide a method to assess the effect of artefacts during the <em style="mso-bidi-font-style: normal;">clinical investigation</em> (e.g. motion artefacts induced by the movement of the subject or the movement of the platform supporting the subject).</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document specifies additional disclosure requirements for the <em style="mso-bidi-font-style: normal;">accompanying documents</em> of <em style="mso-bidi-font-style: normal;">continuous automated non-invasive sphygmomanometers</em> that have undergone <em style="mso-bidi-font-style: normal;">clinical investigation</em> according to this document.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document is not applicable to:</span></p>
<p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 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="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>the <em style="mso-bidi-font-style: normal;">clinical investigation</em> of a <em style="mso-bidi-font-style: normal;">non-automated sphygmomanometer</em> as given in <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">81060</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">1</span></span></span>, </span></p>
<p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 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="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>the <em style="mso-bidi-font-style: normal;">clinical investigation</em> of an <em style="mso-bidi-font-style: normal;">intermittent</em> <em style="mso-bidi-font-style: normal;">automated non-invasive sphygmomanometer</em> as given in <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">81060</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">2</span></span></span>, </span></p>
<p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 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="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>an <em style="mso-bidi-font-style: normal;">automated</em> <em style="mso-bidi-font-style: normal;">non-invasive sphygmomanometer</em> as given in <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">IEC</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">80601</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">2-30</span></span></span>, or </span></p>
<p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 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="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span><em style="mso-bidi-font-style: normal;">invasive blood pressure monitoring equipment</em> as given in <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">IEC</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">60601</span></span></span>‑<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">2‑<span style="border: none;">34</span></span></span></span>.</span></p> Reģistrācijas numurs (WIID) 71161 Darbības sfēra <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">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;">continuous automated non-invasive sphygmomanometers</em> used for the measurement of the <em style="mso-bidi-font-style: normal;">blood pressure</em> of a patient.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document does not cover usability aspects such as the form and manner of the data display or output. This document does not specify a numerical threshold on the <em style="mso-bidi-font-style: normal;">minimum output period</em>. A <em style="mso-bidi-font-style: normal;">continuous automated non-invasive sphygmomanometer</em> providing <em style="mso-bidi-font-style: normal;">blood pressure</em> parameters (e.g., <em style="mso-bidi-font-style: normal;">systolic blood pressure</em>, <em style="mso-bidi-font-style: normal;">diastolic blood pressure</em> or <em style="mso-bidi-font-style: normal;">mean arterial pressure</em>) with an <em style="mso-bidi-font-style: normal;">output period</em> considerably larger than 30 s is not typically considered a <em style="mso-bidi-font-style: normal;">continuous automated non-invasive sphygmomanometer</em>.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document covers both trending <em style="mso-bidi-font-style: normal;">continuous automated non-invasive sphygmomanometers</em> and absolute accuracy <em style="mso-bidi-font-style: normal;">continuous automated non-invasive sphygmomanometers</em> and focuses solely on requirements for the <em style="mso-bidi-font-style: normal;">clinical investigation</em>. Representation of output is not covered by this document.</span></p>
<p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 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="mso-bidi-font-size: 12.0pt;">NOTE 1<span style="mso-tab-count: 1;"> </span><span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">IEC</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">62366</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">1</span></span></span> provides requirements on the application of usability engineering to medical devices. The usability engineering <em style="mso-bidi-font-style: normal;">process</em> can be used to clarify for the intended user whether the displayed data concerns absolute accurate values or trending values.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">The requirements and methods for the <em style="mso-bidi-font-style: normal;">clinical investigation</em> of <em style="mso-bidi-font-style: normal;">continuous automated non-invasive sphygmomanometers</em> provided in this document are applicable to any subject population, and any condition of use of the <em style="mso-bidi-font-style: normal;">continuous automated non-invasive sphygmomanometers</em>.</span></p>
<p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 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="mso-bidi-font-size: 12.0pt;">NOTE 2<span style="mso-tab-count: 1;"> </span>Subject populations can, for example, be represented by age or weight ranges.</span></p>
<p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 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="mso-bidi-font-size: 12.0pt;">NOTE 3<span style="mso-tab-count: 1;"> </span>This document does not provide a method to assess the effect of artefacts during the <em style="mso-bidi-font-style: normal;">clinical investigation</em> (e.g. motion artefacts induced by the movement of the subject or the movement of the platform supporting the subject).</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document specifies additional disclosure requirements for the <em style="mso-bidi-font-style: normal;">accompanying documents</em> of <em style="mso-bidi-font-style: normal;">continuous automated non-invasive sphygmomanometers</em> that have undergone <em style="mso-bidi-font-style: normal;">clinical investigation</em> according to this document.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document is not applicable to:</span></p>
<p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 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="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>the <em style="mso-bidi-font-style: normal;">clinical investigation</em> of a <em style="mso-bidi-font-style: normal;">non-automated sphygmomanometer</em> as given in <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">81060</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">1</span></span></span>, </span></p>
<p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 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="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>the <em style="mso-bidi-font-style: normal;">clinical investigation</em> of an <em style="mso-bidi-font-style: normal;">intermittent</em> <em style="mso-bidi-font-style: normal;">automated non-invasive sphygmomanometer</em> as given in <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">81060</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">2</span></span></span>, </span></p>
<p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 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="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>an <em style="mso-bidi-font-style: normal;">automated</em> <em style="mso-bidi-font-style: normal;">non-invasive sphygmomanometer</em> as given in <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">IEC</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">80601</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">2-30</span></span></span>, or </span></p>
<p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 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="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span><em style="mso-bidi-font-style: normal;">invasive blood pressure monitoring equipment</em> as given in <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">IEC</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">60601</span></span></span>‑<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">2‑<span style="border: none;">34</span></span></span></span>.</span></p> Statuss Standarts spēkā ICS grupa 11.040.10
