<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 describes in vitro methods of measurement of the sizing parameters for surgical valves (referring to mechanical and stented bioprosthetic valves only here and hereafter). It represents a consensus reached among manufacturers, independent bioengineers and clinicians, and is underpinned by interlaboratory studies.</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 relates to surgical heart valve prostheses and is intended to be used in conjunction with <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext;">ISO</span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext;">5840</span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext;">1</span></span>:<span class="stdyear"><span style="color: black; mso-color-alt: windowtext;">2021</span></span> and <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext;">ISO</span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext;">5840</span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext;">2</span></span>:<span class="stdyear"><span style="color: black; mso-color-alt: windowtext;">2021</span></span>. Where noted, the requirements of this document clarify certain requirements of <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext;">ISO</span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext;">5840</span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext;">1</span></span> and/or <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext;">ISO</span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext;">5840</span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext;">2</span></span>. Specific methodologies are included for flexible leaflet (bioprosthetic) and rigid (mechanical) valves. Sutureless valves, stentless valves and valved conduits are not included.</span></p>
Registration number (WIID)
82572
Scope
<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 describes in vitro methods of measurement of the sizing parameters for surgical valves (referring to mechanical and stented bioprosthetic valves only here and hereafter). It represents a consensus reached among manufacturers, independent bioengineers and clinicians, and is underpinned by interlaboratory studies.</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 relates to surgical heart valve prostheses and is intended to be used in conjunction with <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext;">ISO</span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext;">5840</span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext;">1</span></span>:<span class="stdyear"><span style="color: black; mso-color-alt: windowtext;">2021</span></span> and <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext;">ISO</span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext;">5840</span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext;">2</span></span>:<span class="stdyear"><span style="color: black; mso-color-alt: windowtext;">2021</span></span>. Where noted, the requirements of this document clarify certain requirements of <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext;">ISO</span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext;">5840</span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext;">1</span></span> and/or <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext;">ISO</span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext;">5840</span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext;">2</span></span>. Specific methodologies are included for flexible leaflet (bioprosthetic) and rigid (mechanical) valves. Sutureless valves, stentless valves and valved conduits are not included.</span></p>
