{"id":53975,"date":"2021-05-07T10:20:16","date_gmt":"2021-05-07T14:20:16","guid":{"rendered":"https:\/\/www.livingstonintl.com\/?p=53975"},"modified":"2021-05-07T10:20:21","modified_gmt":"2021-05-07T14:20:21","slug":"avis-de-sante-canada-sur-les-allegations-relatives-aux-proprietes-antimicrobiennes-des-masques-medicaux","status":"publish","type":"post","link":"https:\/\/www.livingstonintl.com\/fr\/avis-de-sante-canada-sur-les-allegations-relatives-aux-proprietes-antimicrobiennes-des-masques-medicaux\/","title":{"rendered":"Avis de Sant\u00e9 Canada sur les all\u00e9gations relatives aux propri\u00e9t\u00e9s antimicrobiennes des masques m\u00e9dicaux"},"content":{"rendered":"\n<p>Le 21 avril 2021, Sant\u00e9 Canada a publi\u00e9 un <a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/covid19-industrie\/instruments-medicaux\/equipement-protection-individuelle\/masques-medicaux-respirateurs\/exigences-techniques-allegations-antimicrobiennes-avis.html\">avis<\/a> qui d\u00e9crit les exigences en mati\u00e8re de s\u00e9curit\u00e9 et d\u2019efficacit\u00e9 pour les masques m\u00e9dicaux et les couvre-visages de classe I avec all\u00e9gations de propri\u00e9t\u00e9s antimicrobiennes. Cet avis s&rsquo;adresse aux fabricants qui utilisent une autorisation en vertu de l&rsquo;arr\u00eat\u00e9 d&rsquo;urgence ou une licence d&rsquo;\u00e9tablissement d&rsquo;instruments m\u00e9dicaux (LEIM) pour fabriquer, importer ou vendre ces dispositifs au Canada.<\/p>\n\n\n\n<p>Cet <a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/covid19-industrie\/instruments-medicaux\/equipement-protection-individuelle\/masques-medicaux-respirateurs\/exigences-techniques-allegations-antimicrobiennes-avis.html\" target=\"_blank\" rel=\"noreferrer noopener\">avis<\/a> ne couvre pas les agents antimicrobiens vendus s\u00e9par\u00e9ment et appliqu\u00e9s sur les couvre-visages ou les masques m\u00e9dicaux avant l\u2019utilisation.<br><br><a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/covid19-industrie\/instruments-medicaux\/equipement-protection-individuelle\/masques-medicaux-respirateurs\/classification-couvre-visages-avis.html\" target=\"_blank\" rel=\"noreferrer noopener\">Les couvre-visages<\/a> ne sont pas class\u00e9s comme dispositifs m\u00e9dicaux \u00e0 moins qu\u2019il y ait des all\u00e9gations ou des d\u00e9clarations m\u00e9dicales.<br>Certains masques et dispositifs de couvre-visage peuvent incorporer ou \u00eatre enduits de mat\u00e9riaux qui font l&rsquo;objet d&rsquo;all\u00e9gations de propri\u00e9t\u00e9s antimicrobiennes. Les substances antimicrobiennes peuvent tuer ou inhiber la croissance des micro-organismes. Voici quelques exemples de substances antimicrobiennes\u00a0:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>argent<\/li><li>cuivre<\/li><li>rev\u00eatement textile contenant du graph\u00e8ne nanoform\u00e9<\/li><li>sel<\/li><\/ul>\n\n\n\n<p>Au Canada, les couvre-visages utilis\u00e9s uniquement pour r\u00e9duire les gouttelettes ou les a\u00e9rosols qui passent entre les personnes ne sont pas r\u00e9glement\u00e9s comme des dispositifs m\u00e9dicaux. Toutefois, si l\u2019\u00e9tiquette du produit comprend des all\u00e9gations de propri\u00e9t\u00e9s antimicrobiennes, ces couvre-visages deviennent des dispositifs m\u00e9dicaux de classe I.<br><br>L\u2019article 25 du <a href=\"https:\/\/laws-lois.justice.gc.ca\/fra\/reglements\/DORS-98-282\/\" target=\"_blank\" rel=\"noreferrer noopener\"><em>R\u00e8glement sur les instruments m\u00e9dicaux<\/em><\/a> permet de demander des renseignements sur la s\u00e9curit\u00e9, l\u2019efficacit\u00e9 et la qualit\u00e9 aupr\u00e8s des fabricants de la cat\u00e9gorie I.<\/p>\n\n\n\n<p><strong>Limites des all\u00e9gations<\/strong><\/p>\n\n\n\n<p>L&rsquo;efficacit\u00e9 de la filtration bact\u00e9rienne est une mesure de la r\u00e9sistance d&rsquo;un mat\u00e9riau de masque m\u00e9dical \u00e0 la p\u00e9n\u00e9tration d&rsquo;un type sp\u00e9cifique de microbe&nbsp;: une bact\u00e9rie de 3&nbsp;\u00b5m (300&nbsp;nm) de diam\u00e8tre. Les r\u00e9sultats sont exprim\u00e9s en pourcentage d\u2019efficacit\u00e9 et sont en corr\u00e9lation avec la capacit\u00e9 du tissu \u00e0 r\u00e9sister \u00e0 la p\u00e9n\u00e9tration bact\u00e9rienne. Des pourcentages de rentabilit\u00e9 plus \u00e9lev\u00e9s dans ce test indiquent une meilleure efficacit\u00e9 de la barri\u00e8re. En g\u00e9n\u00e9ral, une cote d\u2019efficacit\u00e9 \u00e9nerg\u00e9tique de pointe pourrait \u00eatre interpr\u00e9t\u00e9e comme une efficacit\u00e9 de filtration du mat\u00e9riau.<\/p>\n\n\n\n<p>Cette mesure ne doit pas \u00eatre prise s\u00e9par\u00e9ment et sans r\u00e9f\u00e9rence \u00e0 une m\u00e9thode d\u2019essai ou \u00e0 une norme internationale. Pour obtenir un niveau \u00e9lev\u00e9 de filtration, les masques antimicrobiens non m\u00e9dicaux doivent \u00eatre fabriqu\u00e9s \u00e0 partir d\u2019un mat\u00e9riau en polypropyl\u00e8ne non tiss\u00e9. Toutes les all\u00e9gations doivent \u00eatre \u00e9tay\u00e9es par des donn\u00e9es probantes accessibles sur demande aux fins d&rsquo;examen.<\/p>\n\n\n\n<p>Les masques m\u00e9dicaux ou tout autre \u00e9quipement de protection individuelle faisant l&rsquo;objet d&rsquo;all\u00e9gations de propri\u00e9t\u00e9s antimicrobiennes doivent r\u00e9pondre aux exigences en mati\u00e8re de s\u00e9curit\u00e9 et d\u2019efficacit\u00e9 d\u00e9crites ci-dessous. Ces renseignements doivent \u00eatre accessibles pour examen sur demande dans le cas des d\u00e9tenteurs de LEIM. Ils doivent \u00eatre soumis par les fabricants qui d\u00e9posent une <a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/medicaments\/annonces\/arrete-urgence-importation-vente-instruments-medicaux-covid-19\/document-applications-dispositifs-medicaux.html\" target=\"_blank\" rel=\"noreferrer noopener\">demande en vertu d&rsquo;un arr\u00eat\u00e9 d&rsquo;urgence<\/a> ou qui r\u00e9pondent aux demandes en mati\u00e8re d\u2019information r\u00e9glementaires.<\/p>\n\n\n\n<p>Consultez <a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/covid19-industrie\/instruments-medicaux\/equipement-protection-individuelle\/masques-medicaux-respirateurs\/exigences-techniques-allegations-antimicrobiennes-avis.html\" target=\"_blank\" rel=\"noreferrer noopener\">l\u2019avis<\/a> pour obtenir des d\u00e9tails complets et plus d\u2019informations en ce qui concerne les masques m\u00e9dicaux.<\/p>\n\n\n\n<p><strong>Autres informations <\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/covid19-industrie\/instruments-medicaux\/arrete-urgence-2-importation-vente-instruments-medicaux.html\" target=\"_blank\" rel=\"noreferrer noopener\">Arr\u00eat\u00e9 d\u2019urgence n\u00b0\u00a02 concernant l\u2019importation et la vente d\u2019instruments m\u00e9dicaux destin\u00e9s \u00e0 \u00eatre utilis\u00e9s \u00e0 l\u2019\u00e9gard de la COVID-19<\/a><\/li><li><a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/medicaments\/annonces\/arrete-urgence-importation-vente-instruments-medicaux-covid-19\/document-applications-dispositifs-medicaux.html\" target=\"_blank\" rel=\"noreferrer noopener\">Demandes relatives aux instruments m\u00e9dicaux vis\u00e9s par l\u2019arr\u00eat\u00e9 d\u2019urgence pour leur utilisation \u00e0 l\u2019\u00e9gard de la COVID-19\u00a0: Ligne directrice<\/a><\/li><li><a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/conformite-application-loi\/licences-etablissement\/formulaires\/demande-licence-etablissement-instruments-medicaux-formulaire-instructions-0292.html\" target=\"_blank\" rel=\"noreferrer noopener\">Demande de licence d\u2019\u00e9tablissement d\u2019instruments m\u00e9dicaux (LEIM)<\/a><\/li><li><a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/services\/medicaments-produits-sante\/medicaments\/annonces\/avis-examen-accelere-presentations-produits-sante-covid-19.html\" target=\"_blank\" rel=\"noreferrer noopener\">Avis\u00a0: Examen acc\u00e9l\u00e9r\u00e9 des pr\u00e9sentations et demandes de produits de sant\u00e9 li\u00e9es \u00e0 la COVID-19<\/a><\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Le 21 avril 2021, Sant\u00e9 Canada a publi\u00e9 un avis qui d\u00e9crit les exigences en mati\u00e8re de s\u00e9curit\u00e9 et d\u2019efficacit\u00e9 pour les masques m\u00e9dicaux et les couvre-visages de classe I avec all\u00e9gations de propri\u00e9t\u00e9s antimicrobiennes. Cet avis s&rsquo;adresse aux fabricants qui utilisent une autorisation en vertu de l&rsquo;arr\u00eat\u00e9 d&rsquo;urgence ou une licence d&rsquo;\u00e9tablissement d&rsquo;instruments m\u00e9dicaux<a class=\"excerpt-read-more\" href=\"https:\/\/www.livingstonintl.com\/fr\/avis-de-sante-canada-sur-les-allegations-relatives-aux-proprietes-antimicrobiennes-des-masques-medicaux\/\" title=\"ReadAvis de Sant\u00e9 Canada sur les all\u00e9gations relatives aux propri\u00e9t\u00e9s antimicrobiennes des masques m\u00e9dicaux\">&#8230; Read more &raquo;<\/a><\/p>\n","protected":false},"author":36,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"class_list":["post-53975","post","type-post","status-publish","format-standard","hentry","category-nouvelles-de-la-reglementation-canadienne"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Avis de Sant\u00e9 Canada sur les all\u00e9gations relatives aux propri\u00e9t\u00e9s antimicrobiennes des masques m\u00e9dicaux - Livingston International<\/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.livingstonintl.com\/fr\/avis-de-sante-canada-sur-les-allegations-relatives-aux-proprietes-antimicrobiennes-des-masques-medicaux\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Avis de Sant\u00e9 Canada sur les all\u00e9gations relatives aux propri\u00e9t\u00e9s antimicrobiennes des masques m\u00e9dicaux - Livingston International\" \/>\n<meta property=\"og:description\" content=\"Le 21 avril 2021, Sant\u00e9 Canada a publi\u00e9 un avis qui d\u00e9crit les exigences en mati\u00e8re de s\u00e9curit\u00e9 et d\u2019efficacit\u00e9 pour les masques m\u00e9dicaux et les couvre-visages de classe I avec all\u00e9gations de propri\u00e9t\u00e9s antimicrobiennes. Cet avis s&rsquo;adresse aux fabricants qui utilisent une autorisation en vertu de l&rsquo;arr\u00eat\u00e9 d&rsquo;urgence ou une licence d&rsquo;\u00e9tablissement d&rsquo;instruments m\u00e9dicaux... 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Cet avis s&rsquo;adresse aux fabricants qui utilisent une autorisation en vertu de l&rsquo;arr\u00eat\u00e9 d&rsquo;urgence ou une licence d&rsquo;\u00e9tablissement d&rsquo;instruments m\u00e9dicaux... Read more &raquo;","og_url":"https:\/\/www.livingstonintl.com\/fr\/avis-de-sante-canada-sur-les-allegations-relatives-aux-proprietes-antimicrobiennes-des-masques-medicaux\/","og_site_name":"Livingston International","article_publisher":"https:\/\/www.facebook.com\/livingstoninternational","article_published_time":"2021-05-07T14:20:16+00:00","article_modified_time":"2021-05-07T14:20:21+00:00","og_image":[{"width":1200,"height":630,"url":"https:\/\/cdn.livingstonintl.com\/livingston-content\/uploads\/2022\/09\/12163235\/2022-livingston-fb.jpg","type":"image\/jpeg"}],"author":"Dan Ovsey","twitter_misc":{"\u00c9crit par":"Dan Ovsey","Dur\u00e9e de lecture estim\u00e9e":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.livingstonintl.com\/fr\/avis-de-sante-canada-sur-les-allegations-relatives-aux-proprietes-antimicrobiennes-des-masques-medicaux\/#article","isPartOf":{"@id":"https:\/\/www.livingstonintl.com\/fr\/avis-de-sante-canada-sur-les-allegations-relatives-aux-proprietes-antimicrobiennes-des-masques-medicaux\/"},"author":{"name":"Dan Ovsey","@id":"https:\/\/www.livingstonintl.com\/fr\/#\/schema\/person\/41a41f5d824482db93829b4697ca9f37"},"headline":"Avis de Sant\u00e9 Canada sur les all\u00e9gations relatives aux propri\u00e9t\u00e9s antimicrobiennes des masques m\u00e9dicaux","datePublished":"2021-05-07T14:20:16+00:00","dateModified":"2021-05-07T14:20:21+00:00","mainEntityOfPage":{"@id":"https:\/\/www.livingstonintl.com\/fr\/avis-de-sante-canada-sur-les-allegations-relatives-aux-proprietes-antimicrobiennes-des-masques-medicaux\/"},"wordCount":657,"commentCount":0,"publisher":{"@id":"https:\/\/www.livingstonintl.com\/fr\/#organization"},"articleSection":["Nouvelles de la r\u00e9glementation canadienne"],"inLanguage":"fr-FR","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/www.livingstonintl.com\/fr\/avis-de-sante-canada-sur-les-allegations-relatives-aux-proprietes-antimicrobiennes-des-masques-medicaux\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/www.livingstonintl.com\/fr\/avis-de-sante-canada-sur-les-allegations-relatives-aux-proprietes-antimicrobiennes-des-masques-medicaux\/","url":"https:\/\/www.livingstonintl.com\/fr\/avis-de-sante-canada-sur-les-allegations-relatives-aux-proprietes-antimicrobiennes-des-masques-medicaux\/","name":"Avis de Sant\u00e9 Canada sur les all\u00e9gations relatives aux propri\u00e9t\u00e9s antimicrobiennes des masques m\u00e9dicaux - 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