<p>This document specifies requirements for the <i>basic safety</i> and <i>essential performance</i> of an <i>oxygen</i> <i>concentrator</i> in combination with its <i>accessories</i>, hereafter referred to as <i>ME equipment, </i>intended to increase the oxygen concentration of gas intended to be delivered to a single <i>patient</i>. Such <i>oxygen</i> <i>concentrators</i> are typically intended for use in the <i>home healthcare environment</i> by a single <i>patient</i> in various environments including any private and public transportation as well as in commercial aircraft.</p>
<p>NOTE 1 Such <i>oxygen concentrators</i> can also be used in professional healthcare facilities<i>.</i></p>
<p>This document is applicable to a <i>transit-operable </i>and non-<i>transit-operable oxygen</i> <i>concentrator.</i> This document is applicable to an <i>oxygen concentrator</i> integrated into or used with other medical devices, <i>ME equipment</i> or <i>ME systems.</i></p>
<p>EXAMPLE 1 An <i>oxygen concentrator</i> with integrated oxygen <i>conserving equipment</i><sup> </sup> function or humidifier function.</p>
<p>EXAMPLE 2 An <i>oxygen concentrator</i> used with a flowmeter stand.</p>
<p>EXAMPLE 3 An <i>oxygen concentrator</i> as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases<sup>[2]</sup>.</p>
<p>EXAMPLE 4 An <i>oxygen concentrator</i> with an integrated liquid reservoir function or gas cylinder filling system function.</p>
<p>This document is also applicable to those <i>accessories</i> intended by their <i>manufacturer</i> to be connected to an <i>oxygen</i> <i>concentrator</i>, where the characteristics of those <i>accessories</i> can affect the <i>basic safety</i> or <i>essential performance</i> of the <i>oxygen</i> <i>concentrator</i>. </p>
<p>NOTE 2 Such <i>accessories</i> can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen <i>conserving equipment.</i></p>
<p>This document does not specify requirements for <i>oxygen</i> <i>concentrators </i>for use with a <i>medical gas pipeline system</i>.</p>
<p>If a clause or subclause is specifically intended to be applicable to <i>ME equipment</i> only, or to <i>ME systems</i> 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 <i>ME equipment</i> and to <i>ME systems</i>, as relevant.</p>
<p><i>Hazards</i> inherent in the intended physiological function of <i>ME equipment</i> or <i>ME systems</i> within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.</p>
<p>NOTE 3 See also 4.2 of the general standard.</p>
Registration number (WIID)
75946
Scope
<p>This document specifies requirements for the <i>basic safety</i> and <i>essential performance</i> of an <i>oxygen</i> <i>concentrator</i> in combination with its <i>accessories</i>, hereafter referred to as <i>ME equipment, </i>intended to increase the oxygen concentration of gas intended to be delivered to a single <i>patient</i>. Such <i>oxygen</i> <i>concentrators</i> are typically intended for use in the <i>home healthcare environment</i> by a single <i>patient</i> in various environments including any private and public transportation as well as in commercial aircraft.</p>
<p>NOTE 1 Such <i>oxygen concentrators</i> can also be used in professional healthcare facilities<i>.</i></p>
<p>This document is applicable to a <i>transit-operable </i>and non-<i>transit-operable oxygen</i> <i>concentrator.</i> This document is applicable to an <i>oxygen concentrator</i> integrated into or used with other medical devices, <i>ME equipment</i> or <i>ME systems.</i></p>
<p>EXAMPLE 1 An <i>oxygen concentrator</i> with integrated oxygen <i>conserving equipment</i><sup> </sup> function or humidifier function.</p>
<p>EXAMPLE 2 An <i>oxygen concentrator</i> used with a flowmeter stand.</p>
<p>EXAMPLE 3 An <i>oxygen concentrator</i> as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases<sup>[2]</sup>.</p>
<p>EXAMPLE 4 An <i>oxygen concentrator</i> with an integrated liquid reservoir function or gas cylinder filling system function.</p>
<p>This document is also applicable to those <i>accessories</i> intended by their <i>manufacturer</i> to be connected to an <i>oxygen</i> <i>concentrator</i>, where the characteristics of those <i>accessories</i> can affect the <i>basic safety</i> or <i>essential performance</i> of the <i>oxygen</i> <i>concentrator</i>. </p>
<p>NOTE 2 Such <i>accessories</i> can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen <i>conserving equipment.</i></p>
<p>This document does not specify requirements for <i>oxygen</i> <i>concentrators </i>for use with a <i>medical gas pipeline system</i>.</p>
<p>If a clause or subclause is specifically intended to be applicable to <i>ME equipment</i> only, or to <i>ME systems</i> 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 <i>ME equipment</i> and to <i>ME systems</i>, as relevant.</p>
<p><i>Hazards</i> inherent in the intended physiological function of <i>ME equipment</i> or <i>ME systems</i> within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.</p>
<p>NOTE 3 See also 4.2 of the general standard.</p>
