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<p class="MsoBodyText"><span lang="EN-GB">This document specifies:</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">the general principles governing the biological evaluation within a <em style="mso-bidi-font-style: normal;">risk management process</em> of 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;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">the general categorization of <em style="mso-bidi-font-style: normal;">gas pathways</em> based on the nature and duration of their contact with the gas stream;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">the evaluation of existing relevant data from all sources;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">the identification of gaps in the available data set on the basis of a <em style="mso-bidi-font-style: normal;">risk analysis</em>;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">the identification of additional data sets necessary to analyse the biological safety of the <em style="mso-bidi-font-style: normal;">gas pathway</em>;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">the assessment of the biological safety of the <em style="mso-bidi-font-style: normal;">gas pathway</em>.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document covers general principles regarding <em style="mso-bidi-font-style: normal;">biocompatibility</em> assessment of <em style="mso-bidi-font-style: normal;">medical device</em> materials, which make up the <em style="mso-bidi-font-style: normal;">gas pathway</em>, in <em style="mso-bidi-font-style: normal;">normal use</em> and <em style="mso-bidi-font-style: normal;">normal condition</em>. This document does not cover biological <em style="mso-bidi-font-style: normal;">hazards</em> arising from mechanical damage.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">The other parts of ISO 18562 cover specific tests that address potentially hazardous substances that are added to the respirable gas stream and establish acceptance criteria for these substances.</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> within the <em style="mso-bidi-font-style: normal;">medical device</em>, which might then be 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> when operated according to the instructions for use. This includes degradation arising from exposure to environmental conditions as well as cleaning, disinfection and sterilisation (i.e. <em style="mso-bidi-font-style: normal;">processing</em>). It also includes user action or inaction (omission) that leads to an unintended or unexpected outcome (result) (i.e. <em style="mso-bidi-font-style: normal;">use error</em>). It does not include conscious/intentional action or inaction that violates the instructions for use and is beyond reasonable <em style="mso-bidi-font-style: normal;">risk control</em> by the <em style="mso-bidi-font-style: normal;">manufacturer</em> (i.e. <em style="mso-bidi-font-style: normal;">abnormal use</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;">medical devices</em> that have direct contact with the <em style="mso-bidi-font-style: normal;">patient</em> or <em style="mso-bidi-font-style: normal;">user</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 equipment, 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 system filters and Y-pieces as well as any breathing <em style="mso-bidi-font-style: normal;">accessories</em> intended to be used with such <em style="mso-bidi-font-style: normal;">medical devices</em>. 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)
83409
Darbības sfēra
<p class="MsoBodyText"><span lang="EN-GB">This document specifies:</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">the general principles governing the biological evaluation within a <em style="mso-bidi-font-style: normal;">risk management process</em> of 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;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">the general categorization of <em style="mso-bidi-font-style: normal;">gas pathways</em> based on the nature and duration of their contact with the gas stream;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">the evaluation of existing relevant data from all sources;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">the identification of gaps in the available data set on the basis of a <em style="mso-bidi-font-style: normal;">risk analysis</em>;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">the identification of additional data sets necessary to analyse the biological safety of the <em style="mso-bidi-font-style: normal;">gas pathway</em>;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">the assessment of the biological safety of the <em style="mso-bidi-font-style: normal;">gas pathway</em>.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document covers general principles regarding <em style="mso-bidi-font-style: normal;">biocompatibility</em> assessment of <em style="mso-bidi-font-style: normal;">medical device</em> materials, which make up the <em style="mso-bidi-font-style: normal;">gas pathway</em>, in <em style="mso-bidi-font-style: normal;">normal use</em> and <em style="mso-bidi-font-style: normal;">normal condition</em>. This document does not cover biological <em style="mso-bidi-font-style: normal;">hazards</em> arising from mechanical damage.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">The other parts of ISO 18562 cover specific tests that address potentially hazardous substances that are added to the respirable gas stream and establish acceptance criteria for these substances.</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> within the <em style="mso-bidi-font-style: normal;">medical device</em>, which might then be 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> when operated according to the instructions for use. This includes degradation arising from exposure to environmental conditions as well as cleaning, disinfection and sterilisation (i.e. <em style="mso-bidi-font-style: normal;">processing</em>). It also includes user action or inaction (omission) that leads to an unintended or unexpected outcome (result) (i.e. <em style="mso-bidi-font-style: normal;">use error</em>). It does not include conscious/intentional action or inaction that violates the instructions for use and is beyond reasonable <em style="mso-bidi-font-style: normal;">risk control</em> by the <em style="mso-bidi-font-style: normal;">manufacturer</em> (i.e. <em style="mso-bidi-font-style: normal;">abnormal use</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;">medical devices</em> that have direct contact with the <em style="mso-bidi-font-style: normal;">patient</em> or <em style="mso-bidi-font-style: normal;">user</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 equipment, 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 system filters and Y-pieces as well as any breathing <em style="mso-bidi-font-style: normal;">accessories</em> intended to be used with such <em style="mso-bidi-font-style: normal;">medical devices</em>. 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>
