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<p class="MsoBodyText"><span lang="EN-GB">This document specifies tests for the emissions of <em style="mso-bidi-font-style: normal;">particulate matter</em> from the <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 tests of this document are intended to quantify particles from 0,25 µm <em style="mso-bidi-font-style: normal;">diameter</em> to 10 µm <em style="mso-bidi-font-style: normal;">diameter</em> that are emitted by 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 respirable gas stream. This document establishes acceptance criteria for these tests.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not address nanoparticles. Insufficient data exist to establish exposure limits for particles less than 0,25 µm <em style="mso-bidi-font-style: normal;">diameter</em>.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not address particles larger than 10 µm <em style="mso-bidi-font-style: normal;">diameter</em>. These particles are deposited in the nasal cavity. Additional information can be needed for <em style="mso-bidi-font-style: normal;">medical devices</em> or <em style="mso-bidi-font-style: normal;">accessories</em> that bypass the nose. This is outside the scope of this document but can be required by some <em style="mso-bidi-font-style: normal;">authorities having jurisdiction</em>.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry.</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 is then conducted 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 particles that are deliberately released by a nebulizer (i.e. the therapeutic agent).</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 <em style="mso-bidi-font-style: normal;">medical gas pipeline systems</em> (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> is not addressed by ISO 18562 (all parts).</span></p>
Reģistrācijas numurs (WIID)
83410
Darbības sfēra
<p class="MsoBodyText"><span lang="EN-GB">This document specifies tests for the emissions of <em style="mso-bidi-font-style: normal;">particulate matter</em> from the <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 tests of this document are intended to quantify particles from 0,25 µm <em style="mso-bidi-font-style: normal;">diameter</em> to 10 µm <em style="mso-bidi-font-style: normal;">diameter</em> that are emitted by 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 respirable gas stream. This document establishes acceptance criteria for these tests.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not address nanoparticles. Insufficient data exist to establish exposure limits for particles less than 0,25 µm <em style="mso-bidi-font-style: normal;">diameter</em>.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not address particles larger than 10 µm <em style="mso-bidi-font-style: normal;">diameter</em>. These particles are deposited in the nasal cavity. Additional information can be needed for <em style="mso-bidi-font-style: normal;">medical devices</em> or <em style="mso-bidi-font-style: normal;">accessories</em> that bypass the nose. This is outside the scope of this document but can be required by some <em style="mso-bidi-font-style: normal;">authorities having jurisdiction</em>.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry.</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 is then conducted 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 particles that are deliberately released by a nebulizer (i.e. the therapeutic agent).</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 <em style="mso-bidi-font-style: normal;">medical gas pipeline systems</em> (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> is not addressed by ISO 18562 (all parts).</span></p>
