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<p class="MsoBodyText"><span lang="EN-GB" style="mso-bidi-font-family: Calibri;">This document applies to transfusion and infusion sets and accessories that come into contact with drugs/infusates during their preparation or use. This includes sets and components used for the delivery and/or preparation of drugs as infusates. This document is not intended to address <span style="mso-spacerun: yes;"> </span>medical devices which are provided integrated with the medicinal product by the manufacturer (e.g. medicinal product mixed with or coated onto the medical device – medicinal product that has ancillary Primary Mode of Action – PMOA) or where the medical device is provided filled with the medicinal product and is part of the medicinal product primary packaging. The method(s) provided are to assess the potential impact on medical device safety and not the functionality/efficacy of the drugs with which the medical device is intended to contact.</span></p>
<p class="MsoBodyText"><span lang="EN-GB" style="mso-bidi-font-family: Calibri;">The impact of the materials of construction, and/or use of the medical device on the quality of the infusate (i.e., its potential alteration, degradation, or retention by the medical device) is not in scope of this document.</span></p>
<p class="MsoBodyText"><span lang="EN-GB" style="mso-bidi-font-family: Calibri;">Due to the continuous development of new drugs and clinical practices for administration of medicinal product, the scope of this document will be limited to assessing the impact of drug carrier solutions that form the </span><span lang="EN-GB">base</span><span lang="EN-GB" style="mso-bidi-font-family: Calibri;"> of the infusates on the medical device rather than testing drugs/medications themselves.</span></p>
<p class="MsoBodyText"><span lang="EN-GB" style="mso-bidi-font-family: Calibri;">This document is limited to assessing the integrity of the medical devices after exposure to the carrier solutions for a specified </span><span lang="EN-GB">period</span><span lang="EN-GB" style="mso-bidi-font-family: Calibri;"> of time. It is not intended to evaluate the biocompatibility of the medical device as that is covered by ISO 10993.</span></p>
<p class="MsoBodyText"><span lang="EN-GB" style="mso-bidi-font-family: Calibri;">When the exterior of the medical device will come into contact with other chemicals (e.g. disinfectants), substances (e.g. oils) or potentially degrading processes (e.g. UV light), this must be taken into consideration but </span><span lang="EN-GB">is</span><span lang="EN-GB" style="mso-bidi-font-family: Calibri;"> out of scope of this document.</span></p>
<p class="Note" style="tab-stops: 20.15pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">NOTE<span style="mso-tab-count: 1;"> </span>Annex C provides explanations about the history of the development of the standard and summarises the different arguments discussed within ISO/TC 76 during the elaboration of this document.</span></p>
Reģistrācijas numurs (WIID)
85861
Darbības sfēra
<p class="MsoBodyText"><span lang="EN-GB" style="mso-bidi-font-family: Calibri;">This document applies to transfusion and infusion sets and accessories that come into contact with drugs/infusates during their preparation or use. This includes sets and components used for the delivery and/or preparation of drugs as infusates. This document is not intended to address <span style="mso-spacerun: yes;"> </span>medical devices which are provided integrated with the medicinal product by the manufacturer (e.g. medicinal product mixed with or coated onto the medical device – medicinal product that has ancillary Primary Mode of Action – PMOA) or where the medical device is provided filled with the medicinal product and is part of the medicinal product primary packaging. The method(s) provided are to assess the potential impact on medical device safety and not the functionality/efficacy of the drugs with which the medical device is intended to contact.</span></p>
<p class="MsoBodyText"><span lang="EN-GB" style="mso-bidi-font-family: Calibri;">The impact of the materials of construction, and/or use of the medical device on the quality of the infusate (i.e., its potential alteration, degradation, or retention by the medical device) is not in scope of this document.</span></p>
<p class="MsoBodyText"><span lang="EN-GB" style="mso-bidi-font-family: Calibri;">Due to the continuous development of new drugs and clinical practices for administration of medicinal product, the scope of this document will be limited to assessing the impact of drug carrier solutions that form the </span><span lang="EN-GB">base</span><span lang="EN-GB" style="mso-bidi-font-family: Calibri;"> of the infusates on the medical device rather than testing drugs/medications themselves.</span></p>
<p class="MsoBodyText"><span lang="EN-GB" style="mso-bidi-font-family: Calibri;">This document is limited to assessing the integrity of the medical devices after exposure to the carrier solutions for a specified </span><span lang="EN-GB">period</span><span lang="EN-GB" style="mso-bidi-font-family: Calibri;"> of time. It is not intended to evaluate the biocompatibility of the medical device as that is covered by ISO 10993.</span></p>
<p class="MsoBodyText"><span lang="EN-GB" style="mso-bidi-font-family: Calibri;">When the exterior of the medical device will come into contact with other chemicals (e.g. disinfectants), substances (e.g. oils) or potentially degrading processes (e.g. UV light), this must be taken into consideration but </span><span lang="EN-GB">is</span><span lang="EN-GB" style="mso-bidi-font-family: Calibri;"> out of scope of this document.</span></p>
<p class="Note" style="tab-stops: 20.15pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">NOTE<span style="mso-tab-count: 1;"> </span>Annex C provides explanations about the history of the development of the standard and summarises the different arguments discussed within ISO/TC 76 during the elaboration of this document.</span></p>
