{"id":21541,"date":"2025-03-20T08:25:25","date_gmt":"2025-04-17T09:45:12","guid":{"rendered":"https:\/\/www.ufi.eu\/pcn\/Bez kategorije\/pcn-ufi-za-proizvode-za-ciscenje-medicinskih-uredaja-eu-2017-745\/"},"modified":"2025-04-17T09:45:12","modified_gmt":"2025-04-17T09:45:12","slug":"pcn-ufi-za-proizvode-za-ciscenje-medicinskih-uredaja-eu-2017-745","status":"publish","type":"product","link":"https:\/\/www.ufi.eu\/hr\/product\/pcn-ufi-za-proizvode-za-ciscenje-medicinskih-uredaja-eu-2017-745\/","title":{"rendered":"PCN &amp; UFI za proizvode za \u010di\u0161\u0107enje medicinskih ure\u0111aja (EU 2017\/745)"},"content":{"rendered":"<h2>Kako funkcionira usluga kreiranja UFI-ja i PCN obavijesti?<\/h2>\n<p>Nakon kupnje ove usluge dobit \u0107ete pristup sigurnom portalu. Ovaj portal sadr\u017ei pregled svih koraka.  Ispunite podatke o proizvodu i mi \u0107emo se baciti na posao.<\/p>\n<h3>Obavijest i UFI Centra za otrove<\/h3>\n<p>Osigurat \u0107emo:<\/p>\n<ul>\n<li>Jedinstveni identifikator formule (UFI) va\u0161eg proizvoda<\/li>\n<li>Izvje\u0161\u0107e Centra za otrovanje (PCN).<\/li>\n<li>Registracija va\u0161eg proizvoda pri relevantnim nacionalnim centrima za otrovanja putem ECHA-e.<\/li>\n<\/ul>\n<h3>Zemlje za PCN registraciju<\/h3>\n<p>Mo\u017eete ra\u010dunati u koliko zemalja \u017eelite registrirati svoj proizvod. Ovo je broj zemalja koje trebate kupiti.  Na portalu \u0107ete mo\u0107i odabrati odre\u0111ene zemlje. Ako kasnije planirate pro\u0161iriti prodaju svojih proizvoda na nove zemlje, uvijek mo\u017eete naru\u010diti dodatne <a href=\"https:\/\/www.ufi.eu\/hr\/pcn\/zemlje\/zemlje-za-pcn-registraciju\/\" target=\"_blank\" title=\"PCN registracije zemalja\">registracije PCN zemalja<\/a> .<br \/> EU ima 27 zemalja, a EEA 30 (EU+Lichtenstein, Norve\u0161ka i Island) Na portalu mo\u017eete odabrati ove zemlje: <\/p>\n<table cellpadding=\"2\" cellspacing=\"0\" border=\"1\">\n<tbody>\n<tr>\n<td>Belgija<\/td>\n<td>(BITI)<\/td>\n<td>\u0160panjolska<\/td>\n<td>(ES)<\/td>\n<td>Ma\u0111arska<\/td>\n<td>(HU)<\/td>\n<td>Slova\u010dka<\/td>\n<td>(SK)<\/td>\n<\/tr>\n<tr>\n<td>Bugarska<\/td>\n<td>(BG)<\/td>\n<td>Francuska<\/td>\n<td>(FR)<\/td>\n<td>Malta<\/td>\n<td>(MT)<\/td>\n<td>Finska<\/td>\n<td>(FI)<\/td>\n<\/tr>\n<tr>\n<td>\u010ce\u0161ka<\/td>\n<td>(CZ)<\/td>\n<td>Hrvatska<\/td>\n<td>(HR)<\/td>\n<td>Nizozemska<\/td>\n<td>(NL)<\/td>\n<td>\u0160vedska<\/td>\n<td>(SE)<\/td>\n<\/tr>\n<tr>\n<td>Danska<\/td>\n<td>(DK)<\/td>\n<td>Italija<\/td>\n<td>(TO)<\/td>\n<td>Austrija<\/td>\n<td>(NA)<\/td>\n<td>Njema\u010dka<\/td>\n<td>(DE)<\/td>\n<\/tr>\n<tr>\n<td>Cipar<\/td>\n<td>(CY)<\/td>\n<td>Poljska<\/td>\n<td>(PL)<\/td>\n<td>Island<\/td>\n<td>(JE)<\/td>\n<td>Estonija<\/td>\n<td>(EE)<\/td>\n<\/tr>\n<tr>\n<td>Latvija<\/td>\n<td>(LV)<\/td>\n<td>Portugal<\/td>\n<td>(PT)<\/td>\n<td>Lihten\u0161tajn<\/td>\n<td>(LI)<\/td>\n<td>Irska<\/td>\n<td>(IE)<\/td>\n<\/tr>\n<tr>\n<td>Litva<\/td>\n<td>(LT)<\/td>\n<td>Rumunija<\/td>\n<td>(RO)<\/td>\n<td>Norve\u0161ka<\/td>\n<td>(NE)<\/td>\n<td>Gr\u010dka<\/td>\n<td>(EL)<\/td>\n<\/tr>\n<tr>\n<td>Luksemburg<\/td>\n<td>(LU)<\/td>\n<td>Slovenija<\/td>\n<td>(SI)<\/td>\n<td>\u0160vicarska*<\/td>\n<td>(CH)<\/td>\n<td><\/td>\n<td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>*Za \u0160vicarsku mo\u017eemo izraditi PCN dosje, sa svim potrebnim informacijama za podno\u0161enje na \u0161vicarskom portalu. Kontaktirajte nas za vi\u0161e informacija. <\/p>\n<h3>Informacije o oznaci CLP<\/h3>\n<p>Nudimo mogu\u0107nost kupnje naljepnice proizvoda uskla\u0111ene s CLP-om, koja sadr\u017ei sve obvezne podatke kako zahtijeva EU CLP Uredba. Ovo \u0107e biti dostavljeno kao PDF.  Ovo nije dizajn, ve\u0107 sa\u017eetak potrebnih informacija. To \u0107e vam omogu\u0107iti da integrirate potrebne informacije u dizajn naljepnice proizvoda. <a href=\"https:\/\/www.ufi.eu\/hr\/pcn\/clp-oznaka\/izrada-clp-oznake-i-provjera-sukladnosti\/\" target=\"_blank\" title=\"CLP labelcCreation\">Izradu CLP naljepnice<\/a> mo\u017eete naru\u010diti i zasebno. Ve\u0107 imate etiketu? \u2014 Mo\u017eemo izvr\u0161iti <a href=\"https:\/\/www.ufi.eu\/hr\/pcn\/clp-oznaka\/izrada-clp-oznake-i-provjera-sukladnosti\/\" target=\"_blank\" title=\"Provjera sukladnosti naljepnice CLP\">provjeru uskla\u0111enosti naljepnice s CLP-om<\/a> na va\u0161oj naljepnici u skladu s trenuta\u010dnim zahtjevima CLP-a. Pru\u017eit \u0107emo detaljne povratne informacije i ispravke kako bismo osigurali da va\u0161a oznaka zadovoljava sve regulatorne standarde.     <\/p>\n<h2>Obavijest Centra za otrovanja za medicinske ure\u0111aje<\/h2>\n<p>Medicinski ure\u0111aji, kako je definirano u Uredbi (EU) 2017\/745 Europskog parlamenta i Vije\u0107a, moraju biti u skladu s propisima EU-a kako bi se osigurala njihova sigurnost i pravilna uporaba u zdravstvenim ustanovama. Za medicinske ure\u0111aje koji sadr\u017ee opasne tvari potrebna je obavijest centra za otrovanje (PCN) za pru\u017eanje detaljnih sigurnosnih informacija u slu\u010daju hitne izlo\u017eenosti. Ova obavijest osigurava da hitne slu\u017ebe i zdravstveni radnici mogu poduzeti odgovaraju\u0107e radnje ako do\u0111e do slu\u010dajnog izlaganja, \u010dime se poma\u017ee u sprje\u010davanju ozljeda pacijenata i korisnika.  <\/p>\n<h3>\u0160to je UFI?<\/h3>\n<p>Jedinstveni identifikator formule (UFI) kod je koji se dodjeljuje mje\u0161avini kemikalija, poput onih koje se koriste u medicinskim ure\u0111ajima koji sadr\u017ee opasne tvari. UFI omogu\u0107uje hitnim slu\u017ebama da brzo identificiraju specifi\u010dnu kemijsku formulaciju proizvoda, poma\u017eu\u0107i u brzom upravljanju svim incidentima izlo\u017eenosti. UFI je uklju\u010den na naljepnici proizvoda kako bi se omogu\u0107io trenutni pristup tim kriti\u010dnim informacijama.  <\/p>\n<h3>\u0160to je PCN?<\/h3>\n<p>Obavijest centra za otrovanje (PCN) izvje\u0161\u0107e je koje dostavljaju proizvo\u0111a\u010di, a sadr\u017ei detaljne informacije o opasnim svojstvima njihovih proizvoda. Za medicinske proizvode, PCN uklju\u010duje podatke o kemijskim tvarima prisutnim u proizvodu, njihovu klasifikaciju prema Uredbi CLP i potrebne mjere prve pomo\u0107i. PCN poma\u017ee hitnim slu\u017ebama da pristupe vitalnim sigurnosnim informacijama u slu\u010daju izlaganja kemikalijama ure\u0111aja.  <\/p>\n<h3>\u0160to je CLP?<\/h3>\n<p>Uredba o razvrstavanju, ozna\u010davanju i pakiranju (CLP) pru\u017ea okvir za razvrstavanje opasnih tvari i smjesa. Nala\u017ee da proizvodi, uklju\u010duju\u0107i medicinske ure\u0111aje s kemijskim tvarima, budu jasno ozna\u010deni simbolima opasnosti, signalnim rije\u010dima i izjavama o mjerama opreza. Ova uredba osigurava da su korisnici i slu\u017ebe za hitne slu\u010dajeve svjesni rizika i da znaju kako sigurno rukovati proizvodom u slu\u010daju nezgoda.  <\/p>\n<h3>\u0160to je Centar za otrovanja?<\/h3>\n<p>Centar za otrovanja je mre\u017ea nacionalnih centara za otrovanja odgovornih za prikupljanje, upravljanje i \u0161irenje informacija o opasnim tvarima i smjesama. Proizvo\u0111a\u010di moraju registrirati svoje opasne proizvode u Centru za otrovanja kako bi osigurali da kriti\u010dne sigurnosne informacije budu dostupne zdravstvenim radnicima i hitnim slu\u017ebama diljem EU-a u slu\u010daju trovanja ili izlaganja. <\/p>\n<h3>Za\u0161to je ovo potrebno?<\/h3>\n<p>PCN je klju\u010dan kako bi se osiguralo da hitne slu\u017ebe imaju to\u010dne i pravovremene informacije o opasnim tvarima u medicinskim ure\u0111ajima. U slu\u010daju izlaganja \u0161tetnim kemikalijama, PCN omogu\u0107uje br\u017eu, u\u010dinkovitiju intervenciju, smanjuju\u0107i rizik od ozljeda ili smrti. Podno\u0161enje PCN-a poma\u017ee u za\u0161titi sigurnosti korisnika i pacijenata tako \u0161to hitne postupke \u010dini u\u010dinkovitijima i osigurava uskla\u0111enost s propisima EU-a.  <\/p>\n<h3>Od kada je to po zakonu obavezno?<\/h3>\n<p>Zahtjev za dostavu PCN-a za medicinske proizvode koji sadr\u017ee opasne tvari stupio je na snagu 1. sije\u010dnja 2021. Prema Uredbi EU CLP (Prilog VIII), proizvo\u0111a\u010di moraju obavijestiti Centar za otrovanja za sve opasne smjese, uklju\u010duju\u0107i one koje se koriste u medicinskim ure\u0111ajima. Ova je uredba dio stalnih napora da se osigura sigurnost proizvoda i pobolj\u0161a odgovor na hitne slu\u010dajeve u cijeloj EU.  <\/p>\n<h2>FAQ<\/h2>\n<h3>Pitanje: Moram li predati PCN za svoj medicinski ure\u0111aj?<\/h3>\n<p>Odgovor: Da, ako va\u0161 medicinski ure\u0111aj sadr\u017ei opasne kemikalije, morate podnijeti obavijest Centru za otrovanja (PCN). To osigurava da slu\u017ebe za hitne slu\u010dajeve imaju potrebne informacije za odgovor na nesre\u0107e ili incidente izlo\u017eenosti koji uklju\u010duju ure\u0111aj. <\/p>\n<h3>Pitanje: Koje su informacije potrebne za podno\u0161enje PCN-a?<\/h3>\n<p>Odgovor: PCN podnesak uklju\u010duje detaljne informacije o kemijskim tvarima u proizvodu, njihovom razvrstavanju prema Uredbi CLP, mjerama hitnog odgovora i UFI. Ove informacije poma\u017eu hitnim slu\u017ebama da brzo i to\u010dno procijene situaciju u slu\u010daju izlo\u017eenosti. <\/p>\n<h3>Pitanje: \u0160to se doga\u0111a ako ne predam PCN za svoj medicinski ure\u0111aj?<\/h3>\n<p>Odgovor: Nepodno\u0161enje PCN-a mo\u017ee rezultirati nov\u010danim kaznama, kaznama i potencijalno uklanjanjem va\u0161eg proizvoda s tr\u017ei\u0161ta. Osim toga, hitnim slu\u017ebama mo\u017eda nedostaju klju\u010dne informacije za u\u010dinkovito upravljanje incidentima izlo\u017eenosti, \u0161to bi moglo dovesti do ozbiljnih zdravstvenih posljedica. <\/p>\n<h3>Pitanje: Kako mogu predati PCN za svoj medicinski ure\u0111aj?<\/h3>\n<p>Odgovor: Za podno\u0161enje PCN-a morat \u0107ete dostaviti UFI, oznaku proizvoda uskla\u0111enu s CLP-om i detaljne informacije o opasnim kemikalijama u ure\u0111aju. Na\u0161a tvrtka Vam mo\u017ee pomo\u0107i u pripremi potrebne dokumentacije i njenom dostavljanju Centru za otrovanja na uskla\u0111enost. <\/p>\n<h3>Pitanje: Koliko je vremena potrebno za podno\u0161enje UFI i PCN obavijesti?<\/h3>\n<p>Treba nam nekoliko dana rada. \u010cim u\u010ditate dokumentaciju, odmah \u0107emo zapo\u010deti. <\/p>\n<h3>Pitanje: Jesam li ja vlasnik PCN obavijesti?<\/h3>\n<p>Da, vi ste vlasnik PCN obavijesti. Vi zadr\u017eavate puno vlasni\u0161tvo nad podacima koje ste dali.  PCN obavijest bit \u0107e dostupna na va\u0161em ECHA ra\u010dunu.<\/p>\n<h3>Pitanje: Je li ova usluga za jedan ili vi\u0161e proizvoda?<\/h3>\n<p>Usluga se odnosi na jedan proizvod.<\/p>\n<h3>Pitanje: Za\u0161to moram platiti za izradu UFI-ja?<\/h3>\n<p>Usluga koju nudimo nije samo pru\u017eanje UFI-ja. UFI je komponenta unutar mnogo opse\u017enijeg procesa.  Osnovna usluga koju pru\u017eamo je priprema i podno\u0161enje Va\u0161e Obavijesti Centra za otrovanje (PCN) nacionalnim imenovanim tijelima putem ECHA portala, \u0161to je obavezan uvjet prema EU CLP Uredbi za stavljanje opasnih smjesa na tr\u017ei\u0161te. Generiranje UFI-ja je najjednostavniji dio. Me\u0111utim, PCN izvje\u0161\u0107e je slo\u017eeno. Zahtijeva detaljan pregled sastojaka\u2014kemijske klasifikacije\u2014formatiran precizno za podno\u0161enje Centru za otrovanja putem ECHA-e.   <\/p>\n<h3>Pitanje: Moja tvrtka nema sjedi\u0161te u EU, kako mogu predati PCN?<\/h3>\n<p>Pru\u017eamo rje\u0161enje za tvrtke koje nemaju sjedi\u0161te u EU. Vi\u0161e informacija mo\u017eete prona\u0107i na stranici <a href=\"https:\/\/www.ufi.eu\/hr\/pcn\/izvan-eu\/pcn-ufi-za-tvrtke-izvan-eu\/\" target=\"_blank\" rel=\"noopener\">PCN &amp; UFI za tvrtke izvan EU<\/a> . <\/p>\n<h3>Pitanje: Mo\u017eete li dostaviti sigurnosno-tehni\u010dke listove u potpunosti u skladu s Uredbom EU (REACH &amp; CLP)?<\/h3>\n<p>Da, mo\u017eemo <a href=\"https:\/\/www.ufi.eu\/hr\/pcn\/sigurnosno-tehnicki-list\/usluga-izrade-sigurnosno-tehnickog-lista-msds-sds\/\" target=\"_blank\"><strong>izraditi sigurnosno-tehni\u010dke listove (SDS)<\/strong><\/a> \u2014 poznate i kao <strong>sigurnosno-tehni\u010dki listovi (MSDS)<\/strong> \u2014 prilago\u0111ene va\u0161em proizvodu i u skladu s najnovijim propisima EU-a. Bez obzira proizvodite li kemijske smjese, uvozite proizvode u EU ili distribuirate pod privatnom robnom markom, uskla\u0111en SDS je zakonski obavezan i neophodan za sigurnu upotrebu u cijelom opskrbnom lancu. Vi\u0161e \u0107ete prona\u0107i na stranici <a href=\"https:\/\/www.ufi.eu\/hr\/pcn\/sigurnosno-tehnicki-list\/usluga-izrade-sigurnosno-tehnickog-lista-msds-sds\/\" target=\"_blank\">usluge izrade sigurnosno-tehni\u010dkog lista (MSDS\/SDS)<\/a> .  <\/p>\n","protected":false},"excerpt":{"rendered":"<p>Kako funkcionira usluga kreiranja UFI-ja i PCN obavijesti? Nakon kupnje ove usluge dobit \u0107ete pristup sigurnom portalu. Ovaj portal sadr\u017ei pregled svih koraka. Ispunite podatke o proizvodu i mi \u0107emo se baciti na posao. Obavijest i UFI Centra za otrove Osigurat \u0107emo: Jedinstveni identifikator formule (UFI) va\u0161eg proizvoda Izvje\u0161\u0107e Centra za otrovanje (PCN). Registracija va\u0161eg [&hellip;]<\/p>\n","protected":false},"featured_media":21542,"template":"","meta":[],"product_brand":[],"product_cat":[1061],"product_tag":[],"class_list":["post-21541","product","type-product","status-publish","has-post-thumbnail","product_cat-medicinski-uredaji","first","instock","virtual","taxable","purchasable","product-type-bundle"],"bundled_by":[],"bundle_stock_status":"instock","bundle_stock_quantity":"","bundle_virtual":false,"bundle_layout":"default","bundle_add_to_cart_form_location":"default","bundle_editable_in_cart":false,"bundle_sold_individually_context":"product","bundle_item_grouping":"parent","bundle_min_size":"","bundle_max_size":"","bundle_price":{"price":{"min":{"incl_tax":"121","excl_tax":"100"},"max":{"incl_tax":"","excl_tax":""}},"regular_price":{"min":{"incl_tax":"121","excl_tax":"100"},"max":{"incl_tax":"","excl_tax":""}}},"bundled_items":[{"bundled_item_id":10272,"product_id":12524,"menu_order":0,"quantity_min":1,"quantity_max":1,"quantity_default":1,"priced_individually":true,"shipped_individually":true,"override_title":false,"title":null,"override_description":false,"description":null,"optional":false,"hide_thumbnail":false,"discount":"","override_variations":false,"allowed_variations":[""],"override_default_variation_attributes":false,"default_variation_attributes":[],"single_product_visibility":"visible","cart_visibility":"visible","order_visibility":"visible","single_product_price_visibility":"visible","cart_price_visibility":"visible","order_price_visibility":"visible","stock_status":"in_stock"},{"bundled_item_id":10273,"product_id":12514,"menu_order":1,"quantity_min":1,"quantity_max":"","quantity_default":1,"priced_individually":true,"shipped_individually":true,"override_title":false,"title":null,"override_description":false,"description":null,"optional":false,"hide_thumbnail":false,"discount":"","override_variations":false,"allowed_variations":[""],"override_default_variation_attributes":false,"default_variation_attributes":[],"single_product_visibility":"visible","cart_visibility":"visible","order_visibility":"visible","single_product_price_visibility":"visible","cart_price_visibility":"visible","order_price_visibility":"visible","stock_status":"in_stock"}],"bundle_sell_ids":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.1 (Yoast SEO v25.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>PCN &amp; UFI za proizvode za \u010di\u0161\u0107enje medicinskih ure\u0111aja (EU 2017\/745) - UFI<\/title>\n<meta name=\"description\" content=\"Nabavite PCN &amp; UFI za medicinske ure\u0111aje prema EU Uredbi 2017\/745. 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