{"id":7037,"date":"2020-07-24T19:02:07","date_gmt":"2020-07-24T18:02:07","guid":{"rendered":"https:\/\/www.hex-group.eu\/?p=7037"},"modified":"2022-01-21T16:39:22","modified_gmt":"2022-01-21T15:39:22","slug":"testen-op-op-maskers-voor-medisch-en-of-chirurgisch-gebruik","status":"publish","type":"post","link":"https:\/\/www.hex-group.eu\/nl_BE\/testen-op-op-maskers-voor-medisch-en-of-chirurgisch-gebruik\/","title":{"rendered":"Testen op op MASKERS <br> VOOR MEDISCH en\/of <br> CHIRURGISCH GEBRUIK"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">Wat is een medisch of chirurgisch masker?<\/h2>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<div class=\"wp-block-image\"><figure class=\"aligncenter size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"637\" src=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2020\/05\/20200527_masque-chirurgicaux.png\" alt=\"\" class=\"wp-image-5755\" srcset=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2020\/05\/20200527_masque-chirurgicaux.png 800w, https:\/\/www.hex-group.eu\/wp-content\/uploads\/2020\/05\/20200527_masque-chirurgicaux-300x239.png 300w, https:\/\/www.hex-group.eu\/wp-content\/uploads\/2020\/05\/20200527_masque-chirurgicaux-768x612.png 768w, https:\/\/www.hex-group.eu\/wp-content\/uploads\/2020\/05\/20200527_masque-chirurgicaux-650x518.png 650w, https:\/\/www.hex-group.eu\/wp-content\/uploads\/2020\/05\/20200527_masque-chirurgicaux-400x319.png 400w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/figure><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p><strong>Een masker voor medisch of chirurgisch gebruik wordt beschouwd als een medisch hulpmiddel. Het vangt speekseldruppels op of microorganismen uit de neus en de mond wanneer de drager ervan uitademt. Het is uitsluitend voor eenmalig gebruik. Gedragen door medisch personeel, het beschermt daardoor de pati\u00ebnt, hetoperatieveld of apparatuur. Gedragen door een besmettelijk persoon, hij\/zij beschermt daardoor de mensen in zijn\/haar directe omgeving.<\/strong><\/p>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:57px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Wat moet er worden gecontroleerd op de verpakking van een medisch of chirurgisch masker?<\/h2>\n\n\n\n<p>In Europa moet een dergelijk masker verwijzen naar de norm EN 14683: 2019 + AC 2019 waarbij het type eveneens wordt vermeld (cf. Zie hieronder)<\/p>\n\n\n\n<div style=\"height:57px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Aan welke eisen moeten deze maskers voldoen?<\/h2>\n\n\n\n<p>Zoals hierboven aangegeven, is de norm EN 14683: 2019 + AC die deze vereisten specifieert.<br>4 prestatiecriteria worden gedefinieerd om de kwaliteit van maskers voor medisch of chirurgisch gebruik te verifi\u00ebren:<\/p>\n\n\n\n<ol class=\"wp-block-list\" type=\"1\"><li>Bacteri\u00eble Filtratie Effici\u00ebntie (BFE)<br><img decoding=\"async\" width=\"500\" height=\"288\" class=\"wp-image-7015\" style=\"width: 500px;\" src=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2020\/07\/BFE_Actu.png\" alt=\"\" srcset=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2020\/07\/BFE_Actu.png 400w, https:\/\/www.hex-group.eu\/wp-content\/uploads\/2020\/07\/BFE_Actu-300x173.png 300w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/><\/li><li>Bepalen van het ademend vermogen door de differenti\u00eble druk te meten<\/li><li>Bioburden test of microbial cleanliness<\/li><li>Splashtest of spatweerstand<\/li><\/ol>\n\n\n\n<div style=\"height:57px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Zijn er verschillende niveau\u2019s voor medische of chirurgische maskers?<\/h2>\n\n\n\n<p>Ja, de norm EN14683 maakt een onderscheid tussen 3 types maskers<\/p>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading\"><em>Uittreksel \u00a75.2.7 van de norm EN 14683&nbsp;: 2019 + AC&nbsp;: 2019<\/em><\/h4>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td class=\"has-text-align-center\" data-align=\"center\">TEST<\/td><td class=\"has-text-align-center\" data-align=\"center\">Type I*<\/td><td class=\"has-text-align-center\" data-align=\"center\">Type II<\/td><td class=\"has-text-align-center\" data-align=\"center\">Type IIR<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Bacterial filtration efficiency (BFE), (%)<\/td><td class=\"has-text-align-center\" data-align=\"center\">\u2265 95<\/td><td class=\"has-text-align-center\" data-align=\"center\">\u2265 98<\/td><td class=\"has-text-align-center\" data-align=\"center\">\u2265 98<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Differential pressure (Pa\/cm\u00b2)<\/td><td class=\"has-text-align-center\" data-align=\"center\">&lt; 40<\/td><td class=\"has-text-align-center\" data-align=\"center\">&lt;40<\/td><td class=\"has-text-align-center\" data-align=\"center\">&lt; 60<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Splash resistance (kPa)<\/td><td class=\"has-text-align-center\" data-align=\"center\">Non exig\u00e9e<\/td><td class=\"has-text-align-center\" data-align=\"center\">Non exig\u00e9e<\/td><td class=\"has-text-align-center\" data-align=\"center\">\u2265 16,0<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Microbial cleanliness (ufc\/g)<\/td><td class=\"has-text-align-center\" data-align=\"center\">\u2264 30<\/td><td class=\"has-text-align-center\" data-align=\"center\">\u2264 30<\/td><td class=\"has-text-align-center\" data-align=\"center\">\u2264 30<\/td><\/tr><\/tbody><\/table><figcaption>Type 1 medical face masks should only be used for patients and other persons to reduce the risk of spread of infections particularly in epidemic or pandemic situations. Typ 1 masks are not intended for use by healthcare professionnals in an operating room or in other medical settings with similar requirements<\/figcaption><\/figure>\n\n\n\n<div style=\"height:57px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Voert HeX de tests uit volgende EN 14683?<\/h2>\n\n\n\n<p>Ja, HeX voert de tests uit op de maskers voor medisch of chirurgisch gebruik volgens de vereisten van EN 14683.<\/p>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading\"><em>Samenvattende tabel van de tests uitgevoerd door HeX en vergeleken met de eisen van de norm EN 14683<\/em><\/h4>\n\n\n\n<figure class=\"wp-block-table is-style-regular\"><table><tbody><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Test<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>Type I<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>Type II<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>Type IIR<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>R\u00e9alis\u00e9 par HeX<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Bacteri\u00eble filtratie effici\u00ebntie (BFE)<\/td><td class=\"has-text-align-center\" data-align=\"center\">Vereist<\/td><td class=\"has-text-align-center\" data-align=\"center\">Vereist<\/td><td class=\"has-text-align-center\" data-align=\"center\">Vereist<\/td><td class=\"has-text-align-center\" data-align=\"center\"><img decoding=\"async\" src=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2020\/07\/check-1.png\" alt=\"\" style=\"width: 40px;\"><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Differentieel drukverschil<\/td><td class=\"has-text-align-center\" data-align=\"center\">Vereist<\/td><td class=\"has-text-align-center\" data-align=\"center\">Vereist<\/td><td class=\"has-text-align-center\" data-align=\"center\">Vereist<\/td><td class=\"has-text-align-center\" data-align=\"center\"><img decoding=\"async\" src=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2020\/07\/check-1.png\" alt=\"\" style=\"width: 40px;\"><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Bioburden \/ microbial cleanliness<\/td><td class=\"has-text-align-center\" data-align=\"center\">Vereist<\/td><td class=\"has-text-align-center\" data-align=\"center\">Vereist<\/td><td class=\"has-text-align-center\" data-align=\"center\">Vereist<\/td><td class=\"has-text-align-center\" data-align=\"center\"><img decoding=\"async\" src=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2020\/07\/check-1.png\" alt=\"\" style=\"width: 40px;\"><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Splashtest of spatweerstand<\/td><td class=\"has-text-align-center\" data-align=\"center\">NIET Vereist<\/td><td class=\"has-text-align-center\" data-align=\"center\">NIET Vereist<\/td><td class=\"has-text-align-center\" data-align=\"center\">Vereist<\/td><td class=\"has-text-align-center\" data-align=\"center\">&nbsp;<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<div style=\"height:57px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Hoe garandeert HeX de kwaliteit van de resultaten van deze tests?<\/h2>\n\n\n\n<p>Zoals de meeste tests die HeX aanbiedt (meer dan 40) aan zijn klanten in de farmaceutische sector of gezondheidszorg, voert HeX deze tests uit in overeenstemming met de vereisten van de ISO17025 norm. De standaard voor test- en kalibratielaboratoria.<\/p>\n\n\n\n<div style=\"height:57px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Ben ik verplicht de testen te laten uitvoeren door een geaccrediteerd labo?<\/h2>\n\n\n\n<p>Er is geen enkele wettelijke bepaling of verplichting in Europa die vereist dat de testen op maskers voor medisch of chirurgisch gebruik uitgevoerd worden door een geaccrediteerd labo volgens de ISO17025 norm.<\/p>\n\n\n\n<div style=\"height:57px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Welke testen worden voorgesteld in het kader van de COVID-19 pandemie?<\/h2>\n\n\n\n<p>HeX kan 3 testen, hierboven geciteerd, uitvoeren. Meer bepaald: de bacteri\u00eble filter effici\u00ebntie, het differentieel drukverschil en bioburden (microbial cleanliness).<\/p>\n\n\n\n<p>In Belgi\u00eb heeft het FAGG (Federaal Agenstchap voor Geneesmiddelen en Geonzdheidsproducten) een vereenvoudigd protocol ge\u00efmplementeerd. De inspectiediensten van het FAGG stellen vast dat de aangeboden chirurgische mondmaskers vaak niet voorzien zijn van de nodige verklaringen, certificaten en testrapporten waarmee eenduidig kan worden aangetoond dat ze voldoen aan de vereisten van de geldende Europese norm (EN 14683:2019 + AC:2019) <strong><em>(Uittreksel van de FAGG-website)<\/em><\/strong><\/p>\n\n\n\n<p>Dit ATP protocol is gebaseerd op het uitvoeren van \u00e9\u00e9n of twee testen en dit in functie van de verkregen resultaten. E\u00e9n enkel labo wordt momenteel erkend als bevoegd om deze tests uit te voeren volgens het vereenvoudigd protocol (ATP).<\/p>\n\n\n\n<div style=\"height:57px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Wat is de waarde van de testresultaten van HeX vergeleken met de resultaten volgens het ATP protocol van Belgi\u00eb?<\/h2>\n\n\n\n<p>Het ATP protocol is per definitie een vereenvoudigd protocol in vergelijking met de norm EN14683 (aantal tests en gedegradeerde testcondities of vereenvoudigd), de resultaten van testrapporten die voldoen aan alle vereisten van de norm EN 14683, kunnen juridisch niet bestreden worden.<\/p>\n\n\n\n<div style=\"height:39px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"has-text-align-center wp-block-heading\">Voor al uw vragen, neem&nbsp;<br><strong><a href=\"https:\/\/www.hex-group.eu\/nl_BE\/contact\/\">CONTACT met ons op<\/a><\/strong><\/h2>\n\n\n\n<div style=\"height:57px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Wat is een medisch of chirurgisch masker? Een masker voor medisch of chirurgisch gebruik wordt beschouwd als een medisch hulpmiddel. Het vangt speekseldruppels op of microorganismen uit de neus en de mond wanneer de drager ervan uitademt. Het is uitsluitend voor eenmalig gebruik. Gedragen door medisch personeel, het beschermt daardoor de pati\u00ebnt, hetoperatieveld of apparatuur&#8230;.  <a class=\"excerpt-read-more\" href=\"https:\/\/www.hex-group.eu\/nl_BE\/testen-op-op-maskers-voor-medisch-en-of-chirurgisch-gebruik\/\" title=\"Read Testen op op MASKERS &lt;br&gt; VOOR MEDISCH en\/of &lt;br&gt; CHIRURGISCH GEBRUIK\">Read more &raquo;<\/a><\/p>\n","protected":false},"author":21,"featured_media":15798,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"content-type":"","footnotes":""},"categories":[126],"tags":[],"class_list":["post-7037","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-masques-nl_be"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Testen op op MASKERS  VOOR MEDISCH en\/of  CHIRURGISCH GEBRUIK - HeX Group<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.hex-group.eu\/nl_BE\/testen-op-op-maskers-voor-medisch-en-of-chirurgisch-gebruik\/\" \/>\n<meta property=\"og:locale\" content=\"nl_BE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Testen op op MASKERS  VOOR MEDISCH en\/of  CHIRURGISCH GEBRUIK - HeX Group\" \/>\n<meta property=\"og:description\" content=\"Wat is een medisch of chirurgisch masker? Een masker voor medisch of chirurgisch gebruik wordt beschouwd als een medisch hulpmiddel. Het vangt speekseldruppels op of microorganismen uit de neus en de mond wanneer de drager ervan uitademt. Het is uitsluitend voor eenmalig gebruik. Gedragen door medisch personeel, het beschermt daardoor de pati\u00ebnt, hetoperatieveld of apparatuur.... 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