<p><span lang="EN-GB">This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator. </span></p>
<p><span lang="EN-GB">NOTE 1 Conserving equipment can also be used in professional health care facilities.</span></p>
<p><span lang="EN-GB">This document is also applicable to conserving equipment that is incorporated with other equipment. </span></p>
<p><span lang="EN-GB">EXAMPLE Conserving equipment combined with a pressure regulator</span><span lang="EN-GB">[4]</span><span lang="EN-GB">, an oxygen concentrator</span><span lang="EN-GB">[12]</span><span lang="EN-GB"> or liquid oxygen equipment</span><span lang="EN-GB">[7]</span><span lang="EN-GB">.</span></p>
<p><span lang="EN-GB">This document is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment. </span></p>
<p><span lang="EN-GB">This document is intended to clarify the difference in operation of various conserving equipment models, as well as between the operation of conserving equipment and continuous flow oxygen equipment, by requiring standardized performance testing and labelling.</span></p>
<p><span lang="EN-GB">This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas). </span></p>
<p><span lang="EN-GB">If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems 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 ME equipment and to ME systems, as relevant.</span></p>
<p><span lang="EN-GB">Hazards</span><span lang="EN-GB"> inherent in the intended physiological function of ME equipment or ME systems 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.</span></p>
<p>NOTE<span lang="EN-GB"> 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.</span></p>
Registration number (WIID)
87163
Scope
<p><span lang="EN-GB">This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator. </span></p>
<p><span lang="EN-GB">NOTE 1 Conserving equipment can also be used in professional health care facilities.</span></p>
<p><span lang="EN-GB">This document is also applicable to conserving equipment that is incorporated with other equipment. </span></p>
<p><span lang="EN-GB">EXAMPLE Conserving equipment combined with a pressure regulator</span><span lang="EN-GB">[4]</span><span lang="EN-GB">, an oxygen concentrator</span><span lang="EN-GB">[12]</span><span lang="EN-GB"> or liquid oxygen equipment</span><span lang="EN-GB">[7]</span><span lang="EN-GB">.</span></p>
<p><span lang="EN-GB">This document is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment. </span></p>
<p><span lang="EN-GB">This document is intended to clarify the difference in operation of various conserving equipment models, as well as between the operation of conserving equipment and continuous flow oxygen equipment, by requiring standardized performance testing and labelling.</span></p>
<p><span lang="EN-GB">This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas). </span></p>
<p><span lang="EN-GB">If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems 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 ME equipment and to ME systems, as relevant.</span></p>
<p><span lang="EN-GB">Hazards</span><span lang="EN-GB"> inherent in the intended physiological function of ME equipment or ME systems 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.</span></p>
<p>NOTE<span lang="EN-GB"> 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.</span></p>
