{"id":4289,"date":"2025-10-21T11:25:24","date_gmt":"2025-10-21T11:25:24","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=4289"},"modified":"2025-10-21T11:25:24","modified_gmt":"2025-10-21T11:25:24","slug":"new-eu-harmonized-standards-for-surgical-clothing-medical-face-masks-and-sterilizers","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/new-eu-harmonized-standards-for-surgical-clothing-medical-face-masks-and-sterilizers\/","title":{"rendered":"New EU Harmonized Standards for Surgical Clothing, Medical Face Masks, and Sterilizers"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><article>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_74 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Alternar tabla de contenidos\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-harmonized-standards-for-surgical-clothing-medical-face-masks-and-sterilizers\/#What_is_Decision_EU_20252078\" >What is Decision (EU) 2025\/2078?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-harmonized-standards-for-surgical-clothing-medical-face-masks-and-sterilizers\/#Why_is_it_important\" >Why is it important?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-harmonized-standards-for-surgical-clothing-medical-face-masks-and-sterilizers\/#Which_standards_are_included\" >Which standards are included?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-harmonized-standards-for-surgical-clothing-medical-face-masks-and-sterilizers\/#What_changes_for_stakeholders\" >What changes for stakeholders?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-harmonized-standards-for-surgical-clothing-medical-face-masks-and-sterilizers\/#When_does_it_enter_into_force\" >When does it enter into force?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-harmonized-standards-for-surgical-clothing-medical-face-masks-and-sterilizers\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"What_is_Decision_EU_20252078\"><\/span>What is Decision (EU) 2025\/2078?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>On <strong>17 October 2025<\/strong>, the European Commission adopted <strong>Implementing Decision (EU) 2025\/2078<\/strong>, which <strong>amends Implementing Decision (EU) 2021\/1182<\/strong> regarding harmonized standards applicable<br \/>\nto surgical clothing and drapes, medical face masks, and sterilizers for medical purposes.<br \/>\n<a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2025\/2078\/oj\" target=\"_blank\" rel=\"noopener\">Read the full text on <\/a><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2025\/2078\/oj\" target=\"_blank\" rel=\"noopener noreferrer\"><u><b>EUR-Lex<\/b><\/u><\/a><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2025\/2078\/oj\" target=\"_blank\" rel=\"noopener noreferrer\">.<\/a><\/p>\n<p>The main goal is to include newly revised European standards (EN) that reflect the latest technical<br \/>\nand scientific developments in the field.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Why_is_it_important\"><\/span>Why is it important?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li>Harmonized standards provide <strong>presumption of conformity<\/strong> with the essential requirements of <strong><a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\/eng\" target=\"_blank\" rel=\"noopener noreferrer\"><u>Regulation (EU) 2017\/745 on medical devices<\/u><\/a><\/strong>.<\/li>\n<li>By updating standards <strong>EN 13795-1 and 2<\/strong> (surgical clothing), <strong>EN 14683<\/strong> (medical face masks), and <strong>EN 14180<\/strong> (sterilizers) to their 2025 versions, the EU seeks to improve product quality, safety, and reliability across the internal market.<\/li>\n<li>For manufacturers, distributors, notified bodies, and healthcare professionals, being aware of these updates is crucial to ensure compliance and to avoid marketing products that no longer meet EU regulatory expectations.<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Which_standards_are_included\"><\/span>Which standards are included?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li><strong>EN 13795-1:2025<\/strong> \u2014 <em>Surgical clothing and drapes \u2013 Requirements and test methods \u2013 Part 1: Surgical drapes and gowns<\/em><\/li>\n<li><strong>EN 13795-2:2025<\/strong> \u2014 <em>Surgical clothing and drapes \u2013 Requirements and test methods \u2013 Part 2: Clean air suits<\/em><\/li>\n<li><strong>EN 14683:2025<\/strong> \u2014 <em>Medical face masks \u2013 Requirements and test methods<\/em><\/li>\n<li><strong>EN 14180:2025<\/strong> \u2014 <em>Sterilizers for medical purposes \u2013 Low temperature steam and formaldehyde sterilizers \u2013 Requirements and testing<\/em><\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"What_changes_for_stakeholders\"><\/span>What changes for stakeholders?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li><strong>Manufacturers<\/strong> of surgical clothing, drapes, medical face masks, and sterilizers must assess their products against the updated standards to maintain presumption of conformity.<\/li>\n<li><strong>Testing and certification bodies<\/strong> need to align their procedures and assessments with the 2025 versions of the standards.<\/li>\n<li><strong>Distributors and healthcare institutions<\/strong> must ensure that all marketed or procured products comply with the latest harmonized versions.<\/li>\n<li><strong>Market surveillance authorities<\/strong> will increase oversight of compliance, as the new standards represent a higher technical benchmark.<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"When_does_it_enter_into_force\"><\/span>When does it enter into force?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The Decision enters into force on the date of its publication in the <em>Official Journal of the European Union<\/em>. From that date, the listed standards are recognized for presumption of conformity purposes.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong>Implementing Decision (EU) 2025\/2078<\/strong> is a key update for the medical devices sector, introducing revised harmonized standards for surgical clothing, medical face masks, and sterilizers.<\/p>\n<p>Manufacturers, distributors, and healthcare operators should promptly review and adapt their processes to ensure compliance with these updated standards \u2014 maintaining product quality, regulatory alignment, and patient safety.<\/p>\n<\/article>\n<\/div><div style=\"text-align:center;\"><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button_margin-top:10px;--button_margin-bottom:20px;\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/cmcmedicaldevices.com\/contact\/\"><span class=\"fusion-button-text\">Contact us today<\/span><\/a><\/div><div class=\"fusion-image-element \" style=\"text-align:center;--awb-max-width:600px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"2560\" height=\"1465\" title=\"sgs belgium notified body\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/10\/sgs-belgium-notified-body.png\" alt class=\"img-responsive wp-image-4286\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/10\/sgs-belgium-notified-body-200x114.png 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/10\/sgs-belgium-notified-body-400x229.png 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/10\/sgs-belgium-notified-body-600x343.png 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/10\/sgs-belgium-notified-body-800x458.png 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/10\/sgs-belgium-notified-body-1200x687.png 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/10\/sgs-belgium-notified-body.png 2560w\" sizes=\"(max-width: 640px) 100vw, 1200px\" \/><\/span><\/div><\/div><\/div><\/div><\/div>\n\n\n<div class=\"kk-star-ratings kksr-auto kksr-align-center kksr-valign-bottom\"\n    data-payload='{&quot;align&quot;:&quot;center&quot;,&quot;id&quot;:&quot;4289&quot;,&quot;slug&quot;:&quot;default&quot;,&quot;valign&quot;:&quot;bottom&quot;,&quot;ignore&quot;:&quot;&quot;,&quot;reference&quot;:&quot;auto&quot;,&quot;class&quot;:&quot;&quot;,&quot;count&quot;:&quot;7&quot;,&quot;legendonly&quot;:&quot;&quot;,&quot;readonly&quot;:&quot;&quot;,&quot;score&quot;:&quot;5&quot;,&quot;starsonly&quot;:&quot;&quot;,&quot;best&quot;:&quot;5&quot;,&quot;gap&quot;:&quot;5&quot;,&quot;greet&quot;:&quot;Rate this&quot;,&quot;legend&quot;:&quot;5\\\/5 - (7 votos)&quot;,&quot;size&quot;:&quot;24&quot;,&quot;title&quot;:&quot;New EU Harmonized Standards for Surgical Clothing, Medical Face Masks, and Sterilizers&quot;,&quot;width&quot;:&quot;142.5&quot;,&quot;_legend&quot;:&quot;{score}\\\/{best} - ({count} {votes})&quot;,&quot;font_factor&quot;:&quot;1.25&quot;}'>\n            \n<div class=\"kksr-stars\">\n    \n<div class=\"kksr-stars-inactive\">\n            <div class=\"kksr-star\" data-star=\"1\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"2\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"3\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"4\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"5\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n    \n<div class=\"kksr-stars-active\" style=\"width: 142.5px;\">\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n<\/div>\n                \n\n<div class=\"kksr-legend\" style=\"font-size: 19.2px;\">\n            5\/5 - (7 votos)    <\/div>\n    <\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"gallery","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4289","post","type-post","status-publish","format-gallery","hentry","category-sin-categorizar","post_format-post-format-gallery"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.3.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EU Decision 2025\/2078: New Harmonized Standards for Surgical Clothing, Face Masks, and Sterilizers<\/title>\n<meta name=\"description\" content=\"Swissmedic has adopted EU Implementing Regulation (EU) 2025\/1234 on electronic instructions for use with immediate effect. Professional users in Switzerland can now access e-IFUs for all medical devices, accessories, Annex XVI products, and legacy devices, aligning Swiss rules with the EU MDR.Stay compliant with EU medical device regulations. 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