{"id":687,"date":"2022-09-06T14:29:18","date_gmt":"2022-09-06T12:29:18","guid":{"rendered":"https:\/\/www.biotopmedical.nl\/technische-documentatie\/medical-devices-regulations\/biological-safety-asessment\/"},"modified":"2024-04-30T11:31:40","modified_gmt":"2024-04-30T09:31:40","slug":"biologisch-evaluatierapport","status":"publish","type":"page","link":"https:\/\/www.biotopmedical.nl\/nl\/technische-documentatie\/biologisch-evaluatierapport\/","title":{"rendered":"Biologische Evaluatie"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1662038703013{padding-top: 0px !important;padding-bottom: 0px !important;}&#8221; el_class=&#8221;sidebar-row&#8221;][vc_column width=&#8221;1\/4&#8243; col_color=&#8221;bg_lightpurple&#8221; el_class=&#8221;left-sidebar&#8221;]\r\n        <div class=\"sd-block-menu  marginbottom-40px\r\n        \">\r\n        <div class=\"sd-block-title  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444.9 72.19 448 64 448z\"\/><\/svg><\/a>\r\n                            <\/li><li class=\"sub-menu-item current-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/nl\/technische-documentatie\/biologisch-evaluatierapport\/\">Biologische Evaluatie<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/a>\r\n                            <\/li><li class=\"sub-menu-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/nl\/technische-documentatie\/overig\/\">Overig<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/a>\r\n                            <\/li><\/ul><\/li><li class=\"menu-item\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/nl\/persoon-verantwoordelijk-voor-de-naleving-van-de-regelgeving\/\">Person Responsible for Regulatory Compliance (PRRC)<span class=\"expand\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/span><\/a><\/li><\/ul>\r\n        <\/div>\r\n        <div class=\"sd-block-image  align-center marginbottom-40px snake-icon\r\n        \"><img decoding=\"async\" title=\"\" alt=\"\" src=\"https:\/\/www.biotopmedical.nl\/wp-content\/uploads\/2022\/08\/snake-icon-v2-1.svg\" width=\"600\" height=\"500\">\r\n        <\/div>[vc_row_inner][vc_column_inner col_color=&#8221;bg_white&#8221;]\r\n        <div class=\"sd-block-text  marginbottom-0px color-black\r\n        \">\r\n            <p>Voor rechtstreeks contact belt u<br \/>\n<a href=\"tel:+31715280112\">+31 (0)71 528 01 12<\/a><strong><br \/>\n<\/strong><\/p>\n\r\n        <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/12&#8243;][\/vc_column][vc_column css_animation=&#8221;fadeInUp&#8221; width=&#8221;2\/3&#8243; el_class=&#8221;right-sidebar&#8221;]\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h2 class=\"sd-block-title-htag  marginbottom-20px align-left color-purple bg bg-lightpurple font-middle\r\n            \">Diensten<\/h2>\r\n        <\/div>\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h1 class=\"sd-block-title-htag  marginbottom-20px align-left color-white bg bg-purple font-middle\r\n            \">Biologische Evaluatie<\/h1>\r\n        <\/div>[vc_row_inner content_placement=&#8221;middle&#8221;][vc_column_inner width=&#8221;2\/3&#8243;]\r\n        <div class=\"sd-block-text  marginbottom-20px\r\n        \">\r\n            <p>BioTop Medical ondersteunt de fabrikant van het hulpmiddel bij het plannen van de biologische veiligheidsbeoordeling van het hulpmiddel en het schrijven van een objectief rapport conform de norm EN ISO 10993-1.<\/p>\n<p>De Biologische Evaluatie dient om te beoordelen en aan te tonen dat de compatibiliteit tussen de materialen of stoffen van het hulpmiddel die met het lichaam of weefsels in contact komen, kan worden gegarandeerd. Dit is op basis van het type, de duur en de frequentie van het contact. Voor iemand die niet bekend is met geldende normen is dit vaak een ingewikkelde taak.<\/p>\n\r\n        <\/div>[\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;]\r\n        <div class=\"sd-block-image  align-center marginbottom-40px\r\n        \"><img decoding=\"async\" title=\"\" alt=\"\" src=\"https:\/\/www.biotopmedical.nl\/wp-content\/uploads\/2022\/11\/biological_safety_assesment.jpg\" width=\"600\" height=\"500\">\r\n        <\/div>[\/vc_column_inner][\/vc_row_inner]\r\n        <div class=\"sd-block-text  marginbottom-20px\r\n        \">\r\n            <p>Deel I van de norm EN ISO 10993 beschrijft een systematische aanpak voor het uitvoeren van een biologische evaluatie binnen een risicobeheerproces. Deze evaluatie houdt rekening met de precieze identificatie van de materialen die in het hulpmiddel zijn gebruikt en de materialen die zijn gebruikt tijdens de productie van het hulpmiddel, een beoordeling van de impact van het productieproces op de biologische veiligheidskenmerken van het hulpmiddel, de evaluatie van de bestaande klinisch relevante (biocompatibiliteits-) gegevens van deze materialen en, wanneer de gegevens niet bestaan of onvoldoende zijn, het testen van de biocompatibiliteit van het hulpmiddel.<\/p>\n<p>Een van onze doelen bij deze evaluaties is het vermijden van onnodige tests, zowel met het oog op dierenwelzijn als op marktintroductietijd. Hoewel de norm in het verleden misschien werd gezien als een afvinklijst waarvoor klinische eindpunten moesten worden getest, is dit in de Europese Unie zeker niet het geval. Uit onze ervaringen met de FDA blijkt echter dat de autoriteiten in sommige gevallen nog steeds de voorkeur geven aan testen boven argumentatie. In beide gevallen is ons doel het biologische evaluatieproces zo soepel mogelijk te laten verlopen.<\/p>\n\r\n        <\/div>\r\n        <div class=\"sd-block-button  marginbottom-40px style-solid color-purple\">\r\n            <a href=\"https:\/\/www.biotopmedical.nl\/nl\/neem-contact-met-ons-op\/\" title=\"Neem contact op\">Neem contact op<\/a>\r\n        <\/div>[\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1662038703013{padding-top: 0px !important;padding-bottom: 0px !important;}&#8221; el_class=&#8221;sidebar-row&#8221;][vc_column width=&#8221;1\/4&#8243; col_color=&#8221;bg_lightpurple&#8221; el_class=&#8221;left-sidebar&#8221;][vc_row_inner][vc_column_inner col_color=&#8221;bg_white&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/12&#8243;][\/vc_column][vc_column css_animation=&#8221;fadeInUp&#8221; width=&#8221;2\/3&#8243; 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