ISO/TC 121/SC 3

Project No.IEC 80601-2-30:2009
Title<div id="MathJax_Message" style="display: none;"></div> <p>IEC 80601-2-30:2009 <span class="SpellE">applies</span> to <span class="SpellE">the</span> basic <span class="SpellE">safety</span> <span class="SpellE">and</span> essential performance of <span class="SpellE">automated</span> <span class="SpellE">sphygmomanometers</span>, <span class="SpellE">which</span> by <span class="SpellE">means</span> of an <span class="SpellE">inflatable</span> <span class="SpellE">cuff</span> are <span class="SpellE">used</span> for intermittent indirect <span class="SpellE">measurement</span> of <span class="SpellE">the</span> <span class="SpellE">blood</span> pressure <span class="SpellE">without</span> <span class="SpellE">arterial</span> <span class="SpellE">puncture</span>. <span class="SpellE">It</span> <span class="SpellE">covers</span> <span class="SpellE">electrically-powered</span> intermittent, indirect <span class="SpellE">measurement</span> of <span class="SpellE">the</span> <span class="SpellE">blood</span> pressure <span class="SpellE">without</span> <span class="SpellE">arterial</span> <span class="SpellE">puncture</span>, me <span class="SpellE">equipment</span> <span class="SpellE">with</span> <span class="SpellE">automatic</span> <span class="SpellE">methods</span> for <span class="SpellE">estimating</span> <span class="SpellE">blood</span> pressure, <span class="SpellE">including</span> <span class="SpellE">blood</span> pressure monitors for <span class="SpellE">the</span> home <span class="SpellE">healthcare</span> <span class="SpellE">environment</span>. This <span class="SpellE">first</span> <span class="SpellE">edition</span> of IEC 80601-2-30 cancels <span class="SpellE">and</span> replaces <span class="SpellE">the</span> second <span class="SpellE">edition</span> of IEC 60601-2-30, <span class="SpellE">published</span> in 1999. This <span class="SpellE">edition</span> <span class="SpellE">constitutes</span> a major <span class="SpellE">technical</span> <span class="SpellE">revision</span> as <span class="SpellE">well</span> as an <span class="SpellE">alignment</span> <span class="SpellE">with</span> <span class="SpellE">the</span> <span class="SpellE">third</span> <span class="SpellE">edition</span> of IEC 60601-1. <span class="SpellE">Specific</span> <span class="SpellE">technical</span> changes <span class="SpellE">include</span>: expansion of <span class="SpellE">the</span> scope to <span class="SpellE">include</span> all <span class="SpellE">automated</span> <span class="SpellE">sphygmomanometers</span> <span class="SpellE">including</span> <span class="SpellE">those</span> <span class="SpellE">where</span> <span class="SpellE">the</span> patient <span class="SpellE">is</span> <span class="SpellE">the</span> <span class="SpellE">operator</span>, identification of essential performance, new <span class="SpellE">clinical</span> <span class="SpellE">accuracy</span> <span class="SpellE">requirements</span>, <span class="SpellE">additional</span> <span class="SpellE">mechanical</span> <span class="SpellE">strength</span> <span class="SpellE">requirements</span> <span class="SpellE">and</span> prohibition of <span class="SpellE">operator</span> accessible '<span class="SpellE">Luer</span>' <span class="SpellE">connectors</span> in <span class="SpellE">the</span> <span class="SpellE">pneumatic</span> system.<span>      </span></p>
Registration number (WIID)44105
Scope<div id="MathJax_Message" style="display: none;"></div> <p>IEC 80601-2-30:2009 <span class="SpellE">applies</span> to <span class="SpellE">the</span> basic <span class="SpellE">safety</span> <span class="SpellE">and</span> essential performance of <span class="SpellE">automated</span> <span class="SpellE">sphygmomanometers</span>, <span class="SpellE">which</span> by <span class="SpellE">means</span> of an <span class="SpellE">inflatable</span> <span class="SpellE">cuff</span> are <span class="SpellE">used</span> for intermittent indirect <span class="SpellE">measurement</span> of <span class="SpellE">the</span> <span class="SpellE">blood</span> pressure <span class="SpellE">without</span> <span class="SpellE">arterial</span> <span class="SpellE">puncture</span>. <span class="SpellE">It</span> <span class="SpellE">covers</span> <span class="SpellE">electrically-powered</span> intermittent, indirect <span class="SpellE">measurement</span> of <span class="SpellE">the</span> <span class="SpellE">blood</span> pressure <span class="SpellE">without</span> <span class="SpellE">arterial</span> <span class="SpellE">puncture</span>, me <span class="SpellE">equipment</span> <span class="SpellE">with</span> <span class="SpellE">automatic</span> <span class="SpellE">methods</span> for <span class="SpellE">estimating</span> <span class="SpellE">blood</span> pressure, <span class="SpellE">including</span> <span class="SpellE">blood</span> pressure monitors for <span class="SpellE">the</span> home <span class="SpellE">healthcare</span> <span class="SpellE">environment</span>. This <span class="SpellE">first</span> <span class="SpellE">edition</span> of IEC 80601-2-30 cancels <span class="SpellE">and</span> replaces <span class="SpellE">the</span> second <span class="SpellE">edition</span> of IEC 60601-2-30, <span class="SpellE">published</span> in 1999. This <span class="SpellE">edition</span> <span class="SpellE">constitutes</span> a major <span class="SpellE">technical</span> <span class="SpellE">revision</span> as <span class="SpellE">well</span> as an <span class="SpellE">alignment</span> <span class="SpellE">with</span> <span class="SpellE">the</span> <span class="SpellE">third</span> <span class="SpellE">edition</span> of IEC 60601-1. <span class="SpellE">Specific</span> <span class="SpellE">technical</span> changes <span class="SpellE">include</span>: expansion of <span class="SpellE">the</span> scope to <span class="SpellE">include</span> all <span class="SpellE">automated</span> <span class="SpellE">sphygmomanometers</span> <span class="SpellE">including</span> <span class="SpellE">those</span> <span class="SpellE">where</span> <span class="SpellE">the</span> patient <span class="SpellE">is</span> <span class="SpellE">the</span> <span class="SpellE">operator</span>, identification of essential performance, new <span class="SpellE">clinical</span> <span class="SpellE">accuracy</span> <span class="SpellE">requirements</span>, <span class="SpellE">additional</span> <span class="SpellE">mechanical</span> <span class="SpellE">strength</span> <span class="SpellE">requirements</span> <span class="SpellE">and</span> prohibition of <span class="SpellE">operator</span> accessible '<span class="SpellE">Luer</span>' <span class="SpellE">connectors</span> in <span class="SpellE">the</span> <span class="SpellE">pneumatic</span> system.<span>      </span></p>
StatusAtcelts
ICS group11.040.10