{"id":6874,"date":"2026-06-04T17:24:22","date_gmt":"2026-06-04T11:54:22","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6874"},"modified":"2026-06-04T17:24:22","modified_gmt":"2026-06-04T11:54:22","slug":"surgical-face-mask-ce-marking","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/dz-en\/surgical-face-mask-ce-marking\/","title":{"rendered":"Surgical Face Mask CE Marking"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6874\" class=\"elementor elementor-6874\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-63ad848a e-flex e-con-boxed e-con e-parent\" data-id=\"63ad848a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5fdb3ca6 elementor-widget elementor-widget-heading\" data-id=\"5fdb3ca6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Surgical Face Mask CE Marking<\/h1>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1496c889 e-flex e-con-boxed e-con e-parent\" data-id=\"1496c889\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-5108d72b e-con-full e-flex e-con e-child\" data-id=\"5108d72b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-917e325 elementor-widget elementor-widget-text-editor\" data-id=\"917e325\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>\u00a0<\/p><p><span style=\"font-weight: 400;\">Surgical Face Mask CE Marking and EU Registration is mandatory for marketing the medical device in the European region. The present European Medical Device Directive (MDD) has to be followed with regard to Class 1 medical devices. As a requirement of the EU market these products should have CE mark and as <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/ce-marking\/\"><span style=\"font-weight: 400;\">CE mark medical device consultant <\/span><\/a><span style=\"font-weight: 400;\">we can help you in making the technical file for the same.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Face masks become a symbol in each pandemic period. It is very important to wear a mask for a viral enemy that is unclear where it will come from and is not visible even if it is not hidden. Although people sometimes use a scarf wrapped around their face or colorful homemade textiles that cover the mouth and nose, it is best to use masks or, more rarely, N95 masks for effective and healthy protection.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-79cd87b1 e-con-full e-flex e-con e-child\" data-id=\"79cd87b1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5b990dba e-con-full e-flex e-con e-child\" data-id=\"5b990dba\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-38dbc198 elementor-widget elementor-widget-heading\" data-id=\"38dbc198\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Contact Us<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6d316e0 elementor-widget elementor-widget-wpforms\" data-id=\"6d316e0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-6203\"><form id=\"wpforms-form-6203\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"6203\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/dz-en\/wp-json\/wp\/v2\/posts\/6874\" data-token=\"947330bc31d331298c2701c8bb1074b8\" data-token-time=\"1780592115\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\">\t\t<div id=\"wpforms-6203-field_5-container\"\n\t\t\tclass=\"wpforms-field wpforms-field-text\"\n\t\t\tdata-field-type=\"text\"\n\t\t\tdata-field-id=\"5\"\n\t\t\t>\n\t\t\t<label class=\"wpforms-field-label\" for=\"wpforms-6203-field_5\" >Phone Email Paragraph<\/label>\n\t\t\t<input type=\"text\" id=\"wpforms-6203-field_5\" class=\"wpforms-field-medium\" name=\"wpforms[fields][5]\" >\n\t\t<\/div>\n\t\t<div id=\"wpforms-6203-field_1-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_1\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-6203-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Name*\" aria-errormessage=\"wpforms-6203-field_1-error\" required><\/div><div id=\"wpforms-6203-field_2-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_2\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-6203-field_2\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][2]\" placeholder=\"Email*\" spellcheck=\"false\" aria-errormessage=\"wpforms-6203-field_2-error\" required><\/div><div id=\"wpforms-6203-field_3-container\" class=\"wpforms-field wpforms-field-phone\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_3\" aria-hidden=\"false\">Phone <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"tel\" id=\"wpforms-6203-field_3\" class=\"wpforms-field-large wpforms-field-required wpforms-smart-phone-field\" data-rule-smart-phone-field=\"true\" name=\"wpforms[fields][3]\" placeholder=\"Phone*\" aria-label=\"Phone\" aria-errormessage=\"wpforms-6203-field_3-error\" required><\/div><div id=\"wpforms-6203-field_4-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"4\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_4\" aria-hidden=\"false\">Paragraph Text <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-6203-field_4\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][4]\" placeholder=\"Message\" aria-errormessage=\"wpforms-6203-field_4-error\" required><\/textarea><\/div><script>\n\t\t\t\t( function() {\n\t\t\t\t\tconst style = document.createElement( 'style' );\n\t\t\t\t\tstyle.appendChild( document.createTextNode( '#wpforms-6203-field_5-container { position: absolute !important; overflow: hidden !important; display: inline !important; height: 1px !important; width: 1px !important; z-index: -1000 !important; padding: 0 !important; } #wpforms-6203-field_5-container input { visibility: hidden; } #wpforms-conversational-form-page #wpforms-6203-field_5-container label { counter-increment: none; }' ) );\n\t\t\t\t\tdocument.head.appendChild( style );\n\t\t\t\t\tdocument.currentScript?.remove();\n\t\t\t\t} )();\n\t\t\t<\/script><\/div><!-- .wpforms-field-container --><div class=\"wpforms-recaptcha-container wpforms-is-recaptcha wpforms-is-recaptcha-type-v3\" ><input type=\"hidden\" name=\"wpforms[recaptcha]\" value=\"\"><\/div><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"6203\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/posts\/6874\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-6203\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-545c019b e-flex e-con-boxed e-con e-parent\" data-id=\"545c019b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3cbceb47 elementor-widget elementor-widget-text-editor\" data-id=\"3cbceb47\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Surgical Face Mask CE Marking to be offered to users in the European Union countries must comply with the EN 14683 standard, which describes the requirements and test methods for carrying CE marking and medical face masks. This standard has been published in our country by the Turkish Standards Institute (TSE) TS EN 14683 Medical face masks \u2013 Requirements and test methods. Surgical masks are defined as medical equipment covering the mouth, nose and chin of the user according to the standard in question. Masks should act as a barrier between hospital staff and the patient, limiting the passage of an infectious agent. Masks should be produced according to different requirements and should be tested with the recommended methods to determine their performance.<\/span><\/p><p><span style=\"font-weight: 400;\">The classification of masks is mainly based on the results of the following tests:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Bacterial filtration efficiency test<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Breathability (delta P) test<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Splash resistance (synthetic blood) test<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Microbial cleaning test<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Biocompatibility test<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">The basic standard that must be complied with in order to put Surgical Face Mask CE Marking is the TS EN 149 standard (Respiratory protective devices \u2013 Half masks with filters for protection against particles \u2013 Properties, experiments and marking standard). This standard describes the minimum conditions for half masks with filters, respiratory equipment used for protection against particles that cannot be removed from the environment.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b5c070c elementor-widget elementor-widget-heading\" data-id=\"b5c070c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Surgical Face Mask CE Marking\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e3496e5 elementor-widget elementor-widget-text-editor\" data-id=\"e3496e5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Surgical Face Mask CE Marking as a medical device is theoretically possible but there is no standard for this and in the absence of a widely agreed performance benchmark the rules for CE marking medical devices, which require the manufacturer to have clear evidence that the device provides a medical benefit in response to one or more specific illness or disability, actually make it likely that it will cost more and take longer than the Notified Body procedure for PPE.<\/span><\/p><p><span style=\"font-weight: 400;\">If the mask is intended to protect the patient, then the mask would be a Class I Medical Device under the Medical Devices Regulations. The Regulation does not come into force until May of this year, however there is a derogation allowing it to be used in lieu of the old Directive and as such, we would strongly advise manufacturers to use the new Regulation.<\/span><\/p><p><span style=\"font-weight: 400;\">Surgical masks conforming to EN 149 should fit tightly on the face and provide sealing between the face and the mask. In masks designed in this way, breathable air does not leak through the mask wall and passes through filters. For this reason, it is important that surgical masks pass the conformity test.<\/span><\/p><p><span style=\"font-weight: 400;\">CE marking can now be placed on surgical masks that pass these tests under the responsibility of the manufacturer. Surgical Face Mask CE Marking services are also provided to our businesses within the scope of certification services.<\/span><\/p><p><span style=\"font-weight: 400;\">Surgical Face Mask CE Marking is approved for safety, health and environmental protection standards. After tests performed in advanced laboratories, masks are classified as N95, N99 and N100 according to their level of efficiency, and CE marking is put on it by rating it as FFP1, FFP2 or FFP3.<\/span><\/p><p><span style=\"font-weight: 400;\">To sell the device in an EU market device provider should know the regulations, our team of <\/span><a href=\"https:\/\/operonstrategist.com\/\"><span style=\"font-weight: 400;\">medical device regulatory consultants<\/span><\/a><span style=\"font-weight: 400;\"> take a lot of effort to provide regulatory services to the clients.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Surgical Face Mask CE Marking and EU Registration is mandatory for marketing the medical device in the European region. The present European Medical Device Directive (MDD) has to be followed with regard to Class 1 medical devices. As a requirement of the EU market these products should have CE mark and as CE mark medical [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":8860,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[],"class_list":["post-6874","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/posts\/6874","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/comments?post=6874"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/posts\/6874\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/media\/8860"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/media?parent=6874"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/categories?post=6874"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/tags?post=6874"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}