<p>This document is applicable to the <em>basic safety</em> and <em>essential performance</em> of an <em>anaesthetic workstation</em> for administering inhalational anaesthesia whilst continuously attended by a professional <em>operator</em>.</p>
<p>This document specifies particular requirements for a complete <em>anaesthetic workstation</em> and the following <em>anaesthetic workstation</em> components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant <em>anaesthetic workstation</em> components, to form an <em>anaesthetic workstation</em> to a given specification:</p>
<ul>
<li><em>anaesthetic gas delivery system;</em></li>
<li><em>anaesthetic breathing system;</em></li>
<li><em>anaesthetic gas scavenging system (AGSS);</em></li>
<li><em>anaesthetic vapour delivery system;</em></li>
<li><em>anaesthetic ventilator;</em></li>
<li><em>monitoring equipment;</em></li>
<li><em>alarm system;</em></li>
<li><em>protection device.</em></li>
</ul>
<p>NOTE 1 <em>Monitoring equipment, alarm systems </em>and<em> protection devices</em> are summarized in Table AA.1.</p>
<p>An <em>anaesthetic workstation</em> supplied complete and its individual components are considered as <em>ME equipment </em>or <em>ME systems </em>with regard to the general standard.</p>
<p>NOTE 2 The applicability of this document is indicated in Table AA.2.</p>
<p>This document is also applicable to those <em>accessories</em> intended by their <em>manufacturer</em> to be connected to an <em>anaesthetic workstation</em> where the characteristics of those <em>accessories</em> can affect the <em>basic safety </em>and<em> essential performance </em>of the<em> anaesthetic workstation.</em></p>
<p>If a clause or subclause is specifically intended to be applicable to <em>anaesthetic workstation</em> components or its <em>accessories</em> only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to an <em>anaesthetic workstation</em> and its individual components including <em>accessories</em>, as relevant.</p>
<p><em>Hazards</em> inherent in the intended physiological function of an <em>anaesthetic workstation</em> and its individual components including <em>accessories</em> within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.</p>
<p>NOTE 3 See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.</p>
<p>This document is not applicable to any <em>anaesthetic workstation</em> intended for use with flammable anaesthetic agents, as determined by Annex BB.</p>
Registration number (WIID)
76679
Scope
<p>This document is applicable to the <em>basic safety</em> and <em>essential performance</em> of an <em>anaesthetic workstation</em> for administering inhalational anaesthesia whilst continuously attended by a professional <em>operator</em>.</p>
<p>This document specifies particular requirements for a complete <em>anaesthetic workstation</em> and the following <em>anaesthetic workstation</em> components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant <em>anaesthetic workstation</em> components, to form an <em>anaesthetic workstation</em> to a given specification:</p>
<ul>
<li><em>anaesthetic gas delivery system;</em></li>
<li><em>anaesthetic breathing system;</em></li>
<li><em>anaesthetic gas scavenging system (AGSS);</em></li>
<li><em>anaesthetic vapour delivery system;</em></li>
<li><em>anaesthetic ventilator;</em></li>
<li><em>monitoring equipment;</em></li>
<li><em>alarm system;</em></li>
<li><em>protection device.</em></li>
</ul>
<p>NOTE 1 <em>Monitoring equipment, alarm systems </em>and<em> protection devices</em> are summarized in Table AA.1.</p>
<p>An <em>anaesthetic workstation</em> supplied complete and its individual components are considered as <em>ME equipment </em>or <em>ME systems </em>with regard to the general standard.</p>
<p>NOTE 2 The applicability of this document is indicated in Table AA.2.</p>
<p>This document is also applicable to those <em>accessories</em> intended by their <em>manufacturer</em> to be connected to an <em>anaesthetic workstation</em> where the characteristics of those <em>accessories</em> can affect the <em>basic safety </em>and<em> essential performance </em>of the<em> anaesthetic workstation.</em></p>
<p>If a clause or subclause is specifically intended to be applicable to <em>anaesthetic workstation</em> components or its <em>accessories</em> only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to an <em>anaesthetic workstation</em> and its individual components including <em>accessories</em>, as relevant.</p>
<p><em>Hazards</em> inherent in the intended physiological function of an <em>anaesthetic workstation</em> and its individual components including <em>accessories</em> within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.</p>
<p>NOTE 3 See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.</p>
<p>This document is not applicable to any <em>anaesthetic workstation</em> intended for use with flammable anaesthetic agents, as determined by Annex BB.</p>
