{"id":15908,"date":"2016-08-04T20:35:53","date_gmt":"2016-08-04T20:35:53","guid":{"rendered":"https:\/\/ionclinics.com\/blog\/what-is-a-ce-sanitary-certificate-epte\/"},"modified":"2025-05-20T14:52:12","modified_gmt":"2025-05-20T12:52:12","slug":"what-is-a-ce-sanitary-certificate-epte","status":"publish","type":"post","link":"https:\/\/ionclinics.com\/en\/blog\/what-is-a-ce-sanitary-certificate-epte\/","title":{"rendered":"What is a CE sanitary certificate of Product Registration?"},"content":{"rendered":"<p><strong>The CE sanitary certificate of product registration <\/strong>is a mandatory requirement to health\u00a0market products in Europe. A product with health CE\u00a0certificate is easily identified by a label and instructions for use by the CE symbol + serial number. For example:<\/p>\n<figure id=\"attachment_9465\" aria-describedby=\"caption-attachment-9465\" style=\"width: 300px\" class=\"wp-caption aligncenter\"><a href=\"https:\/\/ionclinics.com\/wp-content\/uploads\/2023\/01\/CE-sanitario-TUV-producto-sanitario.png\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-9465 size-medium\" src=\"https:\/\/ionclinics.com\/wp-content\/uploads\/2023\/01\/CE-sanitario-TUV-producto-sanitario.png\" alt=\"CE sanitario y n\u00famero notificado\" width=\"300\" height=\"178\" \/><\/a><figcaption id=\"caption-attachment-9465\" class=\"wp-caption-text\">CE\u00a0sanitary certificate of product registration<\/figcaption><\/figure>\n<p>If a\u00a0<strong>Notified Organization<\/strong> is involved in the evaluation of conformity of the product\u00a0the health CE\u00a0comes with the identification number of the product. (In the picture: 1936 is the\u00a0identification number Notified by T\u00dcV).<\/p>\n<p>In the market, the CE\u00a0shows\u00a0that the product fulfills\u00a0with the directives and legislation that are recommended. <strong>In Europe is\u00a0illegal the sale and subsequent use of products that do not have this certificate<\/strong>, along with the dangers they pose to health. All sanitary products must have a CE sanitary certificate and put it at the disposal of the\u00a0customers.<\/p>\n<p><!--more leer mas--><\/p>\n<h2>CE sanitary certificate as a\u00a0guarantee<\/h2>\n<p>The directives require a minimum requirements sanitary CE\u00a0for proper evaluation and certification of products. The law requires all manufacturers to provide the following guarantees:<\/p>\n<ul>\n<li><strong>Information Guarantee:<\/strong> There must\u00a0be a technical product documentation called Technical File. This includes specifications, plans, user manual, technical assistance manuals\u00a0and accompanying documentation.<\/li>\n<li><strong>Security Guarantee:<\/strong> a product demonstration must\u00a0be made to ensure is in accordance with the rules applied to it, according to their classification.<\/li>\n<li><strong>Guarantee of compliance with specifications and due efficacy:<\/strong> Clinical and, in EPTE\u00ae percutaneous electrolysis therapy case, Clinical for proper evaluation of safety and compliance with product specifications.<\/li>\n<li><strong>Guarantee of Quality:<\/strong> The company must implement a system to ensure the quality according to <a href=\"http:\/\/www.aenor.es\/aenor\/normas\/normas\/fichanorma.asp?tipo=N&amp;codigo=N0049409#.V6NX-bh9671\" target=\"_blank\" rel=\"noopener\">ISO 13485<\/a> with the corresponding monitoring and ensuring their correct implementation.<\/li>\n<\/ul>\n<h3>Sanitary Certificate\u00a0CE\u00a0recognition\u00a0process<\/h3>\n<p>Every product that you want to commercialize as a sanitary product, must follow a <strong>process<\/strong> in order to be recognized as a sanitary product and for it to obtain the <strong>CE sanitary certificate<\/strong> and then be sell:<\/p>\n<figure id=\"attachment_9467\" aria-describedby=\"caption-attachment-9467\" style=\"width: 285px\" class=\"wp-caption aligncenter\"><a href=\"https:\/\/ionclinics.com\/wp-content\/uploads\/2023\/01\/ce-sanitario-proceso-ensayo-laboratorio.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-9467 size-medium\" src=\"https:\/\/ionclinics.com\/wp-content\/uploads\/2023\/01\/ce-sanitario-proceso-ensayo-laboratorio.jpg\" alt=\"CE sanitary process\" width=\"285\" height=\"300\" \/><\/a><figcaption id=\"caption-attachment-9467\" class=\"wp-caption-text\">Process to obtain a\u00a0CE sanitary certificate recognition<\/figcaption><\/figure>\n<p>After the product design, it is necessary to create a documentation to ensure compliance with all applicable laws (Technical File), whose level of demand depends on their classification.The law applied is the UNE-EN &#8211; 60601-1: 2008. + Correction: 2010 for electromedical equipments or the international equivalent that is IEC 60601-1: 2005+ race: 2006. The generated documentation is:<\/p>\n<ul>\n<li>Risk management document;<\/li>\n<li>Document of the validation processes as manufacture, use aptitude, software verification, etc.<\/li>\n<li>Compliance verification of essential requirements in accordance with the law in force.<\/li>\n<\/ul>\n<p>After this, a verification is made by an accredited laboratory to prove that the device respects\u00a0all requirements to be considered as a\u00a0sanitary\u00a0product:<\/p>\n<p>a) Immunity Tests:<\/p>\n<ul>\n<li>Electrostatic discharge;<\/li>\n<li>Immunity to conducted disturbances, induced by RF radio frequency fields;<\/li>\n<li>Magnetic field industrial reference.<\/li>\n<\/ul>\n<p>b) Testing emission (radiation\u00a0emission)<br \/>\nc) <strong>Electrical Safety:<\/strong><\/p>\n<ul>\n<li>Identification and brand;<\/li>\n<li>Protection against electrical dangers;<\/li>\n<li>Protection against mechanical dangers;<\/li>\n<li>Hazards protection from unwanted and excessive radiation;<\/li>\n<li>Hazards\u00a0protection against excessive temperatures and other hazards;<\/li>\n<li>Precision controls, instruments and protection against hazardous outputs;<\/li>\n<li>dangerous situations and fault conditions;<\/li>\n<li>Construction of the product.<\/li>\n<\/ul>\n<p>Once the conformity is obtained, the CE mark is given. This CE mark is still not the <strong>CE sanitary certificate<\/strong>. The process to obtain the CE sanitary certificate has some more steps:<\/p>\n<h2>Get the\u00a0CE sanitary certificate: last steps<\/h2>\n<figure id=\"attachment_19040\" aria-describedby=\"caption-attachment-19040\" style=\"width: 4000px\" class=\"wp-caption aligncenter\"><a href=\"http:\/\/www.electrolisisterapeutica.com\/wp-content\/uploads\/2015\/09\/certificado-ce-sanitario-epte-tuv.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-19040 size-full\" src=\"https:\/\/ionclinics.com\/wp-content\/uploads\/2023\/02\/certificado-CE-sanitario-EPTE-System-scaled.jpg\" alt=\"European Community Sanitary Certificate\" width=\"4000\" height=\"2836\" \/><\/a><figcaption id=\"caption-attachment-19040\" class=\"wp-caption-text\">CE Sanitary Certificate<\/figcaption><\/figure>\n<ul>\n<li>Clinical trial for the CE sanitary certificate;<\/li>\n<li>Contribution of real clinical trials with a valid sample, the experimental group, the control group, authorized test and signed by an ethics committee;<\/li>\n<li>The trial evaluates the device has health benefits.<\/li>\n<\/ul>\n<ul>\n<li>Once all these steps are completed, the documentation has to be delivered to a Notified Organism\u00a0authorized by the European Community and it has to verify and validate the documentation.<\/li>\n<\/ul>\n<p>In addition to this the Notified Organism must audit the quality management system in the manufacturing, storage and distribution process\u00a0according to <strong>ISO 13485<\/strong>. &#8220;This International Standard specifies requirements for a quality management system that can be used by a organization for the\u00a0design and development, production, installation and servicing of medical devices and for the design, development and provision of related services.<\/p>\n<p>Finally, after a favorable audit of the Notified Organism,\u00a0the\u00a0<strong>CE sanitary certificate<\/strong> is obtained.<\/p>\n<blockquote><p>In Europe only medical devices with\u00a0the CE sanitary certificate can be sell.<\/p><\/blockquote>\n<p>The CE sanitary certificate is obligatory and authorities can sanction breaches related to the CE marking of products.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The CE sanitary certificate of product registration is a mandatory requirement to health\u00a0market products in Europe. A product with health CE\u00a0certificate is easily identified by a label and instructions for use by the CE symbol + serial number. For example: If a\u00a0Notified Organization is involved in the evaluation of conformity of the product\u00a0the health CE\u00a0comes [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":15654,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1131,1128,1129,1141],"tags":[1198,1199,1163],"class_list":["post-15908","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-ce-marking-for-medical-devices","category-percutaneous-electrolysis","category-therapeutic-electrolysis","category-training-course","tag-ce-sanitary-certificate","tag-medical-device","tag-percutaneous-electrolysis-therapy"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>What is a CE sanitary certificate of Product Registration?<\/title>\n<meta name=\"description\" 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