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<p>This document applies to the <em>basic safety</em> and <em>essential performance</em> of a <em>humidifier</em>, also hereafter referred to as <em>ME equipment,</em> in combination with its <em>accessories</em>, the combination also hereafter referred to as <em>ME system.</em></p>
<p>This document is also applicable to those <em>accessories</em> intended by their <em>manufacturer</em> to be connected to a <em>humidifier</em> where the characteristics of those <em>accessories</em> can affect the <em>basic safety</em> or <em>essential performance</em> of the <em>humidifier</em>.</p>
<p>EXAMPLE 1 Heated <em>breathing tubes</em> (heated-wire <em>breathing tubes)</em> or <em>ME equipment</em> intended to control these heated <em>breathing tubes</em> (<em>heated breathing tube controllers</em>).</p>
<p>NOTE 1 Heated <em>breathing tubes</em> and their controllers are <em>ME equipment</em> and are subject to the requirements of IEC 60601‑1.</p>
<p>NOTE 2 ISO 5367 specifies other safety and performance requirements for <em>breathing tubes</em>.</p>
<p>This document includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy <em>patients</em>.</p>
<p>NOTE 3 A <em>humidifier</em> can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the <em>humidifier</em>.</p>
<p>EXAMPLE 2 Heated <em>humidifier</em> incorporated into a critical care <em>ventilator</em> where ISO 80601‑2-12<sup>[10]</sup> also applies.</p>
<p>EXAMPLE 3 Heated <em>humidifier</em> incorporated into a homecare <em>ventilator</em> for dependent <em>patients</em> where ISO 80601‑2-72<sup>[12]</sup> also applies.</p>
<p>EXAMPLE 4 Heated <em>humidifier</em> incorporated into sleep apnoea therapy equipment where ISO 80601‑2‑70<sup>[11]</sup> also applies.</p>
<p>EXAMPLE 5 Heated <em>humidifier</em> incorporated into ventilatory support equipment where either ISO 80601-2-79<sup>[13]</sup> or ISO 80601-2-80<sup>[14]</sup> also apply.</p>
<p>EXAMPLE 6 Heated <em>humidifier</em> incorporated into respiratory high-flow therapy equipment where ISO 80601‑2‑90<sup>[15]</sup> also applies.</p>
<p>This document also includes requirements for an <em>active HME</em> (<em>heat and moisture exchanger</em>), <em>ME equipment</em> which actively adds heat and moisture to increase the humidity level of the gas delivered from the <em>HME</em> to the <em>patient</em>. This document is not applicable to a passive <em>HME</em>, which returns a portion of the expired moisture and heat of the <em>patient</em> to the respiratory tract during inspiration without adding heat or moisture.</p>
<p>NOTE 4 ISO 9360‑1 and ISO 9360‑2<sup>[4]</sup> specify safety and performance requirements for a passive <em>HME</em>.</p>
<p>NOTE 5 If a clause or subclause is specifically intended to be applicable to <em>ME equipment</em> only, or to <em>ME systems</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 <em>ME equipment</em> and to <em>ME systems</em>, as relevant.</p>
<p><em>Hazards</em> inherent in the intended physiological function of <em>ME equipment</em> or <em>ME systems</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 6 Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.</p>
<p>This document does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789<sup>[6]</sup>.</p>
<p>This document is not applicable to equipment commonly referred to as “room humidifiers” or humidifiers used in heating, ventilation and air conditioning systems, or <em>humidifiers</em> incorporated into infant incubators.</p>
<p>This document is not applicable to nebulizers used for the delivery of a drug to <em>patients</em>.</p>
<p>NOTE 7 ISO 27427<sup>[7]</sup> specifies the safety and performance requirements for nebulizers.</p>
Reģistrācijas numurs (WIID)
81613
Darbības sfēra
<p>This document applies to the <em>basic safety</em> and <em>essential performance</em> of a <em>humidifier</em>, also hereafter referred to as <em>ME equipment,</em> in combination with its <em>accessories</em>, the combination also hereafter referred to as <em>ME system.</em></p>
<p>This document is also applicable to those <em>accessories</em> intended by their <em>manufacturer</em> to be connected to a <em>humidifier</em> where the characteristics of those <em>accessories</em> can affect the <em>basic safety</em> or <em>essential performance</em> of the <em>humidifier</em>.</p>
<p>EXAMPLE 1 Heated <em>breathing tubes</em> (heated-wire <em>breathing tubes)</em> or <em>ME equipment</em> intended to control these heated <em>breathing tubes</em> (<em>heated breathing tube controllers</em>).</p>
<p>NOTE 1 Heated <em>breathing tubes</em> and their controllers are <em>ME equipment</em> and are subject to the requirements of IEC 60601‑1.</p>
<p>NOTE 2 ISO 5367 specifies other safety and performance requirements for <em>breathing tubes</em>.</p>
<p>This document includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy <em>patients</em>.</p>
<p>NOTE 3 A <em>humidifier</em> can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the <em>humidifier</em>.</p>
<p>EXAMPLE 2 Heated <em>humidifier</em> incorporated into a critical care <em>ventilator</em> where ISO 80601‑2-12<sup>[10]</sup> also applies.</p>
<p>EXAMPLE 3 Heated <em>humidifier</em> incorporated into a homecare <em>ventilator</em> for dependent <em>patients</em> where ISO 80601‑2-72<sup>[12]</sup> also applies.</p>
<p>EXAMPLE 4 Heated <em>humidifier</em> incorporated into sleep apnoea therapy equipment where ISO 80601‑2‑70<sup>[11]</sup> also applies.</p>
<p>EXAMPLE 5 Heated <em>humidifier</em> incorporated into ventilatory support equipment where either ISO 80601-2-79<sup>[13]</sup> or ISO 80601-2-80<sup>[14]</sup> also apply.</p>
<p>EXAMPLE 6 Heated <em>humidifier</em> incorporated into respiratory high-flow therapy equipment where ISO 80601‑2‑90<sup>[15]</sup> also applies.</p>
<p>This document also includes requirements for an <em>active HME</em> (<em>heat and moisture exchanger</em>), <em>ME equipment</em> which actively adds heat and moisture to increase the humidity level of the gas delivered from the <em>HME</em> to the <em>patient</em>. This document is not applicable to a passive <em>HME</em>, which returns a portion of the expired moisture and heat of the <em>patient</em> to the respiratory tract during inspiration without adding heat or moisture.</p>
<p>NOTE 4 ISO 9360‑1 and ISO 9360‑2<sup>[4]</sup> specify safety and performance requirements for a passive <em>HME</em>.</p>
<p>NOTE 5 If a clause or subclause is specifically intended to be applicable to <em>ME equipment</em> only, or to <em>ME systems</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 <em>ME equipment</em> and to <em>ME systems</em>, as relevant.</p>
<p><em>Hazards</em> inherent in the intended physiological function of <em>ME equipment</em> or <em>ME systems</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 6 Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.</p>
<p>This document does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789<sup>[6]</sup>.</p>
<p>This document is not applicable to equipment commonly referred to as “room humidifiers” or humidifiers used in heating, ventilation and air conditioning systems, or <em>humidifiers</em> incorporated into infant incubators.</p>
<p>This document is not applicable to nebulizers used for the delivery of a drug to <em>patients</em>.</p>
<p>NOTE 7 ISO 27427<sup>[7]</sup> specifies the safety and performance requirements for nebulizers.</p>
