{"id":2059,"date":"2025-05-11T18:14:52","date_gmt":"2025-05-11T17:14:52","guid":{"rendered":"https:\/\/verifica.com.ua\/?page_id=2059"},"modified":"2025-05-11T18:57:48","modified_gmt":"2025-05-11T17:57:48","slug":"vimiryuvalna-laboratoriya","status":"publish","type":"page","link":"https:\/\/verifica.com.ua\/en\/vimiryuvalna-laboratoriya\/","title":{"rendered":"Measurement laboratory"},"content":{"rendered":"
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Measurement laboratory<\/h2>\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\t\t<\/section>\n\t\t
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Definition of the CF class:<\/h3>\r\n <\/div>\r\n
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Before starting the certification process, the manufacturer must determine whether the product is a medical device or an auxiliary product to such a medical device, as well as the medical purpose and intended use.<\/p>\n

Criteria and principles of classification of medical devices are determined by Annex 2 of the Technical Regulation on Medical Devices<\/em><\/strong>approved by the CMU Resolution No. 753 dated 02.10.2013.<\/p>\n

Medical device<\/u><\/em> - is any instrument, apparatus, device, device, software, material or other product intended for the diagnosis, treatment, prevention of the human body and (or) ensuring such processes<\/p>\n

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The following types of medical devices are distinguished by their safety level:<\/h3>\r\n <\/div>\r\n
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class I<\/div>\r\n

- low risk share;<\/p>\n<\/div>\r\n <\/div>\r\n

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class IIa <\/div>\r\n

- average risk share;<\/p>\n<\/div>\r\n <\/div>\r\n

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class IIb <\/div>\r\n

- Increased share of risk;<\/p>\n<\/div>\r\n <\/div>\r\n

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class III<\/div>\r\n

- high risk share.<\/p>\n<\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n \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<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

Measuring laboratory Determination of the medical device class: Before starting the certification process, the manufacturer must determine whether the product is a medical device or an auxiliary product to such a medical device, as well as the medical purpose and intended use. Criteria and principles of classification of medical devices are defined in Annex 2 of the Technical Regulation on Medical Devices, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 753 dated 02.10.2013. A medical device is [...].<\/p>","protected":false},"author":10,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-2059","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/verifica.com.ua\/en\/wp-json\/wp\/v2\/pages\/2059","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/verifica.com.ua\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/verifica.com.ua\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/verifica.com.ua\/en\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/verifica.com.ua\/en\/wp-json\/wp\/v2\/comments?post=2059"}],"version-history":[{"count":9,"href":"https:\/\/verifica.com.ua\/en\/wp-json\/wp\/v2\/pages\/2059\/revisions"}],"predecessor-version":[{"id":2114,"href":"https:\/\/verifica.com.ua\/en\/wp-json\/wp\/v2\/pages\/2059\/revisions\/2114"}],"wp:attachment":[{"href":"https:\/\/verifica.com.ua\/en\/wp-json\/wp\/v2\/media?parent=2059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}