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<p class="MsoBodyText"><span lang="EN-GB">This document specifies tests for substances leached by liquid water condensing in <em style="mso-bidi-font-style: normal;">gas pathways</em> of a <em style="mso-bidi-font-style: normal;">medical device</em>, its parts or <em style="mso-bidi-font-style: normal;">accessories,</em> which are intended to provide respiratory care or supply substances via the respiratory tract to a <em style="mso-bidi-font-style: normal;">patient</em> in all environments. The chemical characterization methods described in this document apply to chemical substances that could leach from the <em style="mso-bidi-font-style: normal;">medical device</em>, its parts or <em style="mso-bidi-font-style: normal;">accessories</em> into the condensate. This document establishes verifiable acceptance criteria for these tests. The identity and quantity of each chemical released is intended for toxicological <em style="mso-bidi-font-style: normal;">risk assessment</em> as described in ISO 18562-1:2024.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document addresses potential contamination of the gas stream arising from the <em style="mso-bidi-font-style: normal;">gas pathways</em>, which deliver breathing gas to the <em style="mso-bidi-font-style: normal;">patient</em>.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document applies over the <em style="mso-bidi-font-style: normal;">expected lifetime</em> of the <em style="mso-bidi-font-style: normal;">medical device</em> in <em style="mso-bidi-font-style: normal;">normal use</em> and takes into account the effects of any intended <em style="mso-bidi-font-style: normal;">processing</em>.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not address biological evaluation of the surfaces of <em style="mso-bidi-font-style: normal;">gas pathways</em> that have direct contact with the <em style="mso-bidi-font-style: normal;">patient</em>. The requirements for direct contact surfaces are found in the ISO 10993 series.</span></p>
<p class="MsoBodyText"><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">Medical devices</span></em><span lang="EN-GB">, parts or <em style="mso-bidi-font-style: normal;">accessories</em> containing <em style="mso-bidi-font-style: normal;">gas pathways</em> that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing <em style="mso-bidi-font-style: normal;">accessories</em> intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be <em style="mso-bidi-font-style: normal;">gas pathways</em> and are also addressed by this document.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not address contamination already present in the gas supplied from the gas sources while <em style="mso-bidi-font-style: normal;">medical devices</em> are in <em style="mso-bidi-font-style: normal;">normal use</em>.</span></p>
<p class="Example"><span lang="EN-GB">EXAMPLE<span style="mso-tab-count: 1;"> </span>Contamination arriving at the <em style="mso-bidi-font-style: normal;">medical device</em> from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the <em style="mso-bidi-font-style: normal;">medical device</em>.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not address contact with drugs or anaesthetic agents. If a <em style="mso-bidi-font-style: normal;">medical device</em> or <em style="mso-bidi-font-style: normal;">accessory</em> is intended to be used with anaesthetic agents or drugs, then additional testing can be required. This document is intended to quantify hazardous water-soluble substances that are leached from the <em style="mso-bidi-font-style: normal;">medical device</em>, its parts or <em style="mso-bidi-font-style: normal;">accessories</em> by condensate and then conveyed by that liquid to the <em style="mso-bidi-font-style: normal;">patient</em>.</span></p>
Reģistrācijas numurs (WIID)
82898
Darbības sfēra
<p class="MsoBodyText"><span lang="EN-GB">This document specifies tests for substances leached by liquid water condensing in <em style="mso-bidi-font-style: normal;">gas pathways</em> of a <em style="mso-bidi-font-style: normal;">medical device</em>, its parts or <em style="mso-bidi-font-style: normal;">accessories,</em> which are intended to provide respiratory care or supply substances via the respiratory tract to a <em style="mso-bidi-font-style: normal;">patient</em> in all environments. The chemical characterization methods described in this document apply to chemical substances that could leach from the <em style="mso-bidi-font-style: normal;">medical device</em>, its parts or <em style="mso-bidi-font-style: normal;">accessories</em> into the condensate. This document establishes verifiable acceptance criteria for these tests. The identity and quantity of each chemical released is intended for toxicological <em style="mso-bidi-font-style: normal;">risk assessment</em> as described in ISO 18562-1:2024.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document addresses potential contamination of the gas stream arising from the <em style="mso-bidi-font-style: normal;">gas pathways</em>, which deliver breathing gas to the <em style="mso-bidi-font-style: normal;">patient</em>.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document applies over the <em style="mso-bidi-font-style: normal;">expected lifetime</em> of the <em style="mso-bidi-font-style: normal;">medical device</em> in <em style="mso-bidi-font-style: normal;">normal use</em> and takes into account the effects of any intended <em style="mso-bidi-font-style: normal;">processing</em>.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not address biological evaluation of the surfaces of <em style="mso-bidi-font-style: normal;">gas pathways</em> that have direct contact with the <em style="mso-bidi-font-style: normal;">patient</em>. The requirements for direct contact surfaces are found in the ISO 10993 series.</span></p>
<p class="MsoBodyText"><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">Medical devices</span></em><span lang="EN-GB">, parts or <em style="mso-bidi-font-style: normal;">accessories</em> containing <em style="mso-bidi-font-style: normal;">gas pathways</em> that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing <em style="mso-bidi-font-style: normal;">accessories</em> intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be <em style="mso-bidi-font-style: normal;">gas pathways</em> and are also addressed by this document.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not address contamination already present in the gas supplied from the gas sources while <em style="mso-bidi-font-style: normal;">medical devices</em> are in <em style="mso-bidi-font-style: normal;">normal use</em>.</span></p>
<p class="Example"><span lang="EN-GB">EXAMPLE<span style="mso-tab-count: 1;"> </span>Contamination arriving at the <em style="mso-bidi-font-style: normal;">medical device</em> from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the <em style="mso-bidi-font-style: normal;">medical device</em>.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not address contact with drugs or anaesthetic agents. If a <em style="mso-bidi-font-style: normal;">medical device</em> or <em style="mso-bidi-font-style: normal;">accessory</em> is intended to be used with anaesthetic agents or drugs, then additional testing can be required. This document is intended to quantify hazardous water-soluble substances that are leached from the <em style="mso-bidi-font-style: normal;">medical device</em>, its parts or <em style="mso-bidi-font-style: normal;">accessories</em> by condensate and then conveyed by that liquid to the <em style="mso-bidi-font-style: normal;">patient</em>.</span></p>
