{"id":7098,"date":"2020-08-11T11:06:25","date_gmt":"2020-08-11T10:06:25","guid":{"rendered":"https:\/\/www.hex-group.eu\/?p=7098"},"modified":"2023-09-11T15:10:19","modified_gmt":"2023-09-11T14:10:19","slug":"tests-on-medical-and-or-surgical-masks","status":"publish","type":"post","link":"https:\/\/www.hex-group.eu\/en_BE\/tests-on-medical-and-or-surgical-masks\/","title":{"rendered":"Test of the MASK for MEDICAL and\/or SURGICAL use"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">What is a medical or surgical mask?<\/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%\"><div class=\"wp-block-image\">\n<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>\n<\/div><\/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>A mask for medical or surgical use is a medical device.<\/strong> It traps droplets of saliva or airway secretions when the wearer exhales. It is for single use only. Worn by the caregiver : <strong>it protects the patient,<\/strong> the operating field or the equipment. Worn by the contagious person:<strong> it protects those around him\/her<\/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\">What should be checked on the packaging of a medical or surgical mask?<\/h2>\n\n\n\n<p>A mask for medical or surgical use in Europe must indicate<strong> the reference to the standard EN 14683: 2019 + AC: 2019<\/strong> with the type of mask claimed (see below).<\/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\">What kind of performance requirements does this mask for medical or surgical use meet?<\/h2>\n\n\n\n<p>As indicated above, it is the <strong>EN 14683: 2019 + AC: 2019 standard that specifies the requirement levels.<\/strong>\n<strong>4 performance criteria are expected<\/strong> to verify the quality of masks for medical or surgical use:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Bacterial filtration efficiency (EFB or BFE)<\/strong><\/li>\n\n\n\n<li><strong>Determination of the breathability by measuring the differential pressure<\/strong><\/li>\n\n\n\n<li><strong>Microbial cleanliness<\/strong><\/li>\n\n\n\n<li><strong>Pressure of the splash resistance<\/strong><\/li>\n<\/ul>\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-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-large\"><a href=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2021\/07\/schema-BFE.png\"><img decoding=\"async\" width=\"820\" height=\"791\" src=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2021\/07\/schema-BFE.png\" alt=\"\" class=\"wp-image-12630\" srcset=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2021\/07\/schema-BFE.png 820w, https:\/\/www.hex-group.eu\/wp-content\/uploads\/2021\/07\/schema-BFE-300x289.png 300w, https:\/\/www.hex-group.eu\/wp-content\/uploads\/2021\/07\/schema-BFE-768x741.png 768w, https:\/\/www.hex-group.eu\/wp-content\/uploads\/2021\/07\/schema-BFE-650x627.png 650w, https:\/\/www.hex-group.eu\/wp-content\/uploads\/2021\/07\/schema-BFE-400x386.png 400w\" sizes=\"(max-width: 820px) 100vw, 820px\" \/><\/a><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-large is-resized\"><a href=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2021\/07\/Schema-BFE-1-scaled.jpg\"><img decoding=\"async\" src=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2021\/07\/Schema-BFE-1-682x1024.jpg\" alt=\"\" class=\"wp-image-12633\" style=\"width:252px;height:377px\" width=\"252\" height=\"377\" srcset=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2021\/07\/Schema-BFE-1-682x1024.jpg 682w, https:\/\/www.hex-group.eu\/wp-content\/uploads\/2021\/07\/Schema-BFE-1-200x300.jpg 200w, https:\/\/www.hex-group.eu\/wp-content\/uploads\/2021\/07\/Schema-BFE-1-768x1152.jpg 768w, https:\/\/www.hex-group.eu\/wp-content\/uploads\/2021\/07\/Schema-BFE-1-1024x1536.jpg 1024w, https:\/\/www.hex-group.eu\/wp-content\/uploads\/2021\/07\/Schema-BFE-1-1365x2048.jpg 1365w, https:\/\/www.hex-group.eu\/wp-content\/uploads\/2021\/07\/Schema-BFE-1-433x650.jpg 433w, https:\/\/www.hex-group.eu\/wp-content\/uploads\/2021\/07\/Schema-BFE-1-267x400.jpg 267w, https:\/\/www.hex-group.eu\/wp-content\/uploads\/2021\/07\/Schema-BFE-1-scaled.jpg 1706w\" sizes=\"(max-width: 252px) 100vw, 252px\" \/><\/a><\/figure>\n\n\n\n<p><strong>EFB or BFE test bench<\/strong><\/p>\n<\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Are there different performance levels between masks for medical and surgical use?<\/h2>\n\n\n\n<p>Yes, the <strong>EN 14683: 2019 + AC: 2019 standard distinguishes 3 types of masks:<\/strong><\/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\">Table 1 &#8211; Performance Requirements for Medical Masks<\/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\"><\/td><td class=\"has-text-align-center\" data-align=\"center\"><\/td><td class=\"has-text-align-center\" data-align=\"center\"><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Splash resistance pressure (kPa)<\/td><td class=\"has-text-align-center\" data-align=\"center\">Not required<\/td><td class=\"has-text-align-center\" data-align=\"center\">Not required<\/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 (cfu\/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 class=\"wp-element-caption\">Type I medical masks should be used only for patients and others to reduce the risk of spreading infection, particularly in the context of an epidemic or pandemic. Type I masks are not intended for use by healthcare professionals in operating rooms or other medical facilities with similar requirements.\n<em>Extract \u00a75.2.7 of the standard EN 14683 : 2019 + AC : 2019<\/em><\/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\">Does HeX perform the tests according to<strong> EN 14683: 2019 + AC: 2019 ?<\/strong><\/h2>\n\n\n\n<p>Yes, <strong>HeX performs its tests on masks for medical or surgical use according to the requirements of EN 14683: 2019 + AC: 2019<\/strong><\/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\">Table summarizing the tests proposed by HeX and compared to the requirements of <strong>EN 14683: 2019 + AC: 2019<\/strong><\/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\">Test<\/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>Realized by HeX<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Efficacit\u00e9 de filtration bact\u00e9rienne (EFB ou BFE)<\/td><td class=\"has-text-align-center\" data-align=\"center\">Required<\/td><td class=\"has-text-align-center\" data-align=\"center\">Required<\/td><td class=\"has-text-align-center\" data-align=\"center\">Required<\/td><td class=\"has-text-align-center\" data-align=\"center\"><img decoding=\"async\" style=\"width: 40px;\" src=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2020\/07\/check-1.png\" alt=\"\"><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Differential pressure<\/td><td class=\"has-text-align-center\" data-align=\"center\">Required<\/td><td class=\"has-text-align-center\" data-align=\"center\">Required<\/td><td class=\"has-text-align-center\" data-align=\"center\">Required<\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong><img decoding=\"async\" style=\"width: 40px;\" src=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2020\/07\/check-1.png\" alt=\"\"><\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Microbial cleanliness<\/td><td class=\"has-text-align-center\" data-align=\"center\">Required<\/td><td class=\"has-text-align-center\" data-align=\"center\">Required<\/td><td class=\"has-text-align-center\" data-align=\"center\">Required<\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong><img decoding=\"async\" style=\"width: 40px;\" src=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2020\/07\/check-1.png\" alt=\"\"><\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Pressure of the splash resistance<\/td><td class=\"has-text-align-center\" data-align=\"center\">NO Required<\/td><td class=\"has-text-align-center\" data-align=\"center\">NO Required<\/td><td class=\"has-text-align-center\" data-align=\"center\">Required<\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong><img decoding=\"async\" style=\"width: 40px;\" src=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2020\/07\/check-1.png\" alt=\"\"><\/strong><\/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\">How does HeX ensure the quality of these test results?<\/h2>\n\n\n\n<p>Like most of the tests offered by HeX (more than 40) to its customers in the pharmaceutical and hospital industries, <strong>HeX performs these tests in accordance with the requirements of the ISO 17025 standard expected for testing, calibration and analysis laboratories.<\/strong><\/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\">Do I have to perform these tests in an accredited laboratory?<\/h2>\n\n\n\n<p>There is <strong>no regulatory or legal requirement in Europe<\/strong> for performance testing of masks for medical or surgical use to be performed by ISO 17025 accredited laboratories.<\/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\">What are the trials proposed for the COVID-19 pandemic?<\/h2>\n\n\n\n<p>HeX offers to perform all 3 tests presented above, namely<strong> bacterial filtration efficiency, differential pressure and microbial cleanliness.<\/strong> In Belgium, a<strong> simplified protocol called ATP has been set up by the FAMHP<\/strong> (Federal Agency for Medicines and Health Products). Indeed, the FAMHP inspection services found that the proposed surgical mouth masks do not have the necessary declarations, certificates and test reports to demonstrate unequivocally that they meet the requirements of the applicable European standard (EN 14683: 2019 + AC: 2019) (extract from FAMHP website)\n<strong>This ATP protocol is thus based on the performance of one or two tests depending on the results.<\/strong> Only one laboratory is currently recognized as competent to perform these tests under the simplified ATP protocol.<\/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\">What is the value of the test results from HeX compared to the results from Belgium&#8217;s ATP protocol?<\/h2>\n\n\n\n<p><strong>The ATP protocol being by definition a simplified protocol compared to the EN 14683 : 2019 + AC : 2019 standard<\/strong> (number of tests and conditions of the tests degraded or simplified), the results resulting from test reports satisfying all the requirements of the <strong>EN 14683 : 2019 + AC<\/strong> : 2019 standard could not be opposed from a legal point of view<\/p>\n\n\n\n<div style=\"height:39px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-center\">Online quote request\n<strong><a href=\"https:\/\/www.hex-group.eu\/en_BE\/contact\/\">Contact us<\/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>Bacterial filtration efficiency (EFB or BFE), determination of breathability by measuring the&#8230;<\/p>\n","protected":false},"author":21,"featured_media":15799,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"content-type":"","footnotes":""},"categories":[124],"tags":[],"class_list":["post-7098","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-mask"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Test of the MASK for MEDICAL and\/or SURGICAL use - HeX Group<\/title>\n<meta name=\"description\" content=\"Bacterial filtration efficiency (EFB or BFE), determination of breathability by measuring the differential pressure, microbial cleanliness. 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