{"id":21533,"date":"2025-03-20T08:25:24","date_gmt":"2025-04-17T09:45:08","guid":{"rendered":"https:\/\/www.ufi.eu\/pcn\/Bez kategorije\/pcn-ufi-za-druge-medicinske-uredjaje\/"},"modified":"2025-04-17T09:45:08","modified_gmt":"2025-04-17T09:45:08","slug":"pcn-ufi-za-druge-medicinske-uredjaje","status":"publish","type":"product","link":"https:\/\/www.ufi.eu\/bs\/product\/pcn-ufi-za-druge-medicinske-uredjaje\/","title":{"rendered":"PCN &amp; UFI za druge medicinske ure\u0111aje"},"content":{"rendered":"<h2>Kako funkcionira UFI kreiranje i PCN notifikacija?<\/h2>\n<p>Nakon kupovine ove usluge, dobit \u0107ete pristup sigurnom portalu. Ovaj portal sadr\u017ei pregled svih koraka.  Popunite podatke o svom proizvodu i mi \u0107emo krenuti na posao.<\/p>\n<h3>Obavje\u0161tenje centra za trovanje i UFI<\/h3>\n<p>Mi \u0107emo obezbijediti:<\/p>\n<ul>\n<li>Jedinstveni identifikator formule (UFI) va\u0161eg proizvoda<\/li>\n<li>Izvje\u0161taj centra za otrove (PCN).<\/li>\n<li>Registracija va\u0161eg proizvoda kod relevantnih nacionalnih centara za trovanje putem ECHA.<\/li>\n<\/ul>\n<h3>Zemlje za PCN registraciju<\/h3>\n<p>Mo\u017eete prebrojati broj zemalja u kojima \u017eelite da registrujete svoj proizvod. Ovo je broj zemalja koje trebate kupiti.  Mo\u0107i \u0107ete odabrati odre\u0111ene zemlje unutar portala. Ako kasnije planirate pro\u0161iriti prodaju svojih proizvoda na nove zemlje, uvijek mo\u017eete naru\u010diti dodatne <a href=\"https:\/\/www.ufi.eu\/bs\/pcn\/zemlje-bs\/zemlje-za-pcn-registraciju\/\" target=\"_blank\" title=\"PCN registracije zemalja\">registracije za PCN zemlje<\/a> .<br \/> EU ima 27 zemalja, a EEA 30 (EU+Lihten\u0161tajn, 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>(BE)<\/td>\n<td>Spain<\/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>Holandija<\/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>(IT)<\/td>\n<td>Austrija<\/td>\n<td>(AT)<\/td>\n<td>Njema\u010dka<\/td>\n<td>(DE)<\/td>\n<\/tr>\n<tr>\n<td>Kipar<\/td>\n<td>(CY)<\/td>\n<td>Poljska<\/td>\n<td>(PL)<\/td>\n<td>Island<\/td>\n<td>(IS)<\/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>Litvanija<\/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 \u0160vajcarsku mo\u017eemo kreirati PCN dosije, sa svim potrebnim informacijama za podno\u0161enje na \u0161vajcarskom portalu. Kontaktirajte nas za vi\u0161e informacija. <\/p>\n<h3>Informacije o CLP etiketi<\/h3>\n<p>Nudimo opciju kupovine oznake proizvoda uskla\u0111ene sa CLP, koja sadr\u017ei sve obavezne informacije u skladu sa CLP uredbom EU. Ovo \u0107e biti dostupno kao PDF.  Ovo nije dizajn, ve\u0107 skup potrebnih informacija. To \u0107e vam omogu\u0107iti da integrirate potrebne informacije u dizajn etikete va\u0161eg proizvoda. <a href=\"https:\/\/www.ufi.eu\/bs\/pcn\/clp-etiketa\/izrada-clp-etikete-i-provjera-uskladjenosti\/\" target=\"_blank\" title=\"CLP labelcCreation\">Izradu CLP etikete<\/a> mo\u017eete naru\u010diti i zasebno. Ve\u0107 imate etiketu? \u2014 Mo\u017eemo izvr\u0161iti <a href=\"https:\/\/www.ufi.eu\/bs\/pcn\/clp-etiketa\/izrada-clp-etikete-i-provjera-uskladjenosti\/\" target=\"_blank\" title=\"Provjera uskla\u0111enosti oznake CLP\">provjeru uskla\u0111enosti va\u0161e etikete sa CLP<\/a> etiketom u skladu sa trenutnim zahtjevima CLP-a. Pru\u017eit \u0107emo detaljne povratne informacije i ispravke kako bismo osigurali da va\u0161a etiketa ispunjava sve regulatorne standarde.     <\/p>\n<h2>Obavijest centra za trovanje za druge medicinske ure\u0111aje<\/h2>\n<p>Ostali medicinski ure\u0111aji, koji ne spadaju u posebne kategorije kao \u0161to su proizvodi za \u010di\u0161\u0107enje ili dezinfekciju, i dalje moraju biti u skladu sa propisima EU kada sadr\u017ee opasne supstance. Kako bi se osiguralo da hitne slu\u017ebe i zdravstveni radnici mogu brzo djelovati u slu\u010daju izlo\u017eenosti ili trovanja, potrebno je obavijest centra za trovanje (PCN). Podno\u0161enjem PCN-a, proizvo\u0111a\u010di pru\u017eaju vitalne sigurnosne informacije o hemijskim komponentama u svojim medicinskim ure\u0111ajima, poma\u017eu\u0107i u za\u0161titi zdravlja i sigurnosti korisnika i pacijenata.  <\/p>\n<h3>\u0160ta je UFI?<\/h3>\n<p>Jedinstveni identifikator formule (UFI) je kod koji se koristi za identifikaciju specifi\u010dnih formulacija hemikalija unutar proizvoda. Za medicinske ure\u0111aje, UFI se koristi za pru\u017eanje hitnih slu\u017ebi detaljnih informacija specifi\u010dnih za proizvod o hemijskom sadr\u017eaju. Ovo omogu\u0107ava osobama koje reaguju da identifikuju ta\u010dnu me\u0161avinu i preduzmu odgovaraju\u0107e mere u slu\u010daju nu\u017ede.  <\/p>\n<h3>\u0160ta je PCN?<\/h3>\n<p>Obavje\u0161tenje centra za trovanje (PCN) je izvje\u0161taj koji proizvo\u0111a\u010di moraju dostaviti Centrima za trovanje. Sadr\u017ei kriti\u010dne informacije o opasnim svojstvima proizvoda, uklju\u010duju\u0107i hemikalije koje se koriste u medicinskim ure\u0111ajima. PCN uklju\u010duje klasifikacije opasnosti, mjere prve pomo\u0107i i druge detalje o reagovanju u hitnim slu\u010dajevima. Ove informacije su neophodne za zdravstvene radnike i hitne slu\u017ebe kako bi efikasno upravljali incidentima izlo\u017eenosti hemikalijama.   <\/p>\n<h3>\u0160ta je CLP?<\/h3>\n<p>Uredba o klasifikaciji, ozna\u010davanju i pakovanju (CLP) utvr\u0111uje kriterijume za klasifikaciju hemijskih supstanci i sme\u0161a. Osigurava da su proizvodi, uklju\u010duju\u0107i medicinske ure\u0111aje koji sadr\u017ee opasne tvari, jasno ozna\u010deni simbolima opasnosti, izjavama o mjerama predostro\u017enosti i uputama za prvu pomo\u0107. CLP pru\u017ea standardizirani na\u010din komuniciranja hemijskih opasnosti \u0161irom EU, osiguravaju\u0107i sigurnost i svijest na svim nivoima.  <\/p>\n<h3>\u0160ta je Centar za trovanje?<\/h3>\n<p>Centar za otrove je mre\u017ea nacionalnih centara za kontrolu trovanja koji prikupljaju, obra\u0111uju i pru\u017eaju informacije o opasnim hemikalijama. Proizvo\u0111a\u010di opasnih medicinskih ure\u0111aja moraju registrovati svoje proizvode u Centru za trovanje kako bi se sigurnosne informacije mogle podijeliti sa zdravstvenim radnicima i hitnim slu\u017ebama. To osigurava brz i koordiniran odgovor u slu\u010daju izlaganja kemikalijama.  <\/p>\n<h3>Za\u0161to je ovo potrebno?<\/h3>\n<p>Medicinski proizvodi mogu sadr\u017eavati hemijske supstance koje predstavljaju rizik za korisnike ili pacijente ako su im slu\u010dajno izlo\u017eene. Podno\u0161enje PCN-a poma\u017ee da se osigura da hitne slu\u017ebe i zdravstveni radnici imaju neposredan pristup kriti\u010dnim sigurnosnim informacijama u slu\u010daju izlaganja. Ovaj brzi pristup mo\u017ee napraviti razliku u sprje\u010davanju ili minimiziranju \u0161tete, osiguravaju\u0107i da se medicinski ure\u0111aji koriste bezbedno.  <\/p>\n<h3>Od kada je ovo po zakonu obavezno?<\/h3>\n<p>Od 1. januara 2021. zakonski je zahtjev da proizvo\u0111a\u010di medicinskih ure\u0111aja koji sadr\u017ee opasne hemikalije podnose obavje\u0161tenje centra za trovanje (PCN). Obaveza proizilazi iz EU CLP Uredbe, koja ima za cilj pobolj\u0161anje sigurnosnih standarda i postupaka odgovora na opasne proizvode \u0161irom Evropske unije. Po\u0161tovanje ovog zakona je od su\u0161tinskog zna\u010daja za pristup tr\u017ei\u0161tu i za\u0161titu potro\u0161a\u010da.  <\/p>\n<h2>FAQ<\/h2>\n<h3>Pitanje: Da li trebam dostaviti PCN za svoj medicinski ure\u0111aj?<\/h3>\n<p>Odgovor: Da, ako va\u0161 medicinski ure\u0111aj sadr\u017ei opasne hemikalije, potreban je PCN. Ovo osigurava da osobe koje reaguju u hitnim slu\u010dajevima mogu pristupiti vitalnim informacijama o hemijskim supstancama u va\u0161em proizvodu, pobolj\u0161avaju\u0107i sigurnost u slu\u010daju izlaganja. <\/p>\n<h3>Pitanje: Koje informacije trebam uklju\u010diti u PCN za svoj medicinski ure\u0111aj?<\/h3>\n<p>Odgovor: PCN za va\u0161 medicinski ure\u0111aj mora sadr\u017eavati informacije o opasnim supstancama koje sadr\u017ei, njihovu CLP klasifikaciju, mjere hitne reakcije i UFI. Klju\u010dno je osigurati da su informacije ta\u010dne i uskla\u0111ene sa propisima EU. <\/p>\n<h3>Pitanje: \u0160ta se de\u0161ava ako ne predam PCN za svoj medicinski ure\u0111aj?<\/h3>\n<p>Odgovor: Nedostavljanje PCN-a mo\u017ee dovesti do nov\u010danih kazni, kazni i uklanjanja va\u0161eg proizvoda sa tr\u017ei\u0161ta. Osim toga, hitnim slu\u017ebama mo\u017eda nedostaju kriti\u010dne informacije za upravljanje incidentima izlo\u017eenosti, \u0161to mo\u017ee dovesti do ozbiljnih zdravstvenih posljedica. <\/p>\n<h3>Pitanje: Kako mogu predati PCN za svoj medicinski ure\u0111aj?<\/h3>\n<p>Odgovor: Da biste poslali PCN, morat \u0107ete prikupiti potrebne sigurnosne podatke, uklju\u010duju\u0107i UFI, oznaku proizvoda uskla\u0111enog sa CLP-om i klasifikaciju opasnosti. Na\u0161a kompanija nudi usluge koje \u0107e vam pomo\u0107i da pripremite obavijest o va\u0161em proizvodu i po\u0161aljete je Centru za trovanje radi uskla\u0111enosti. <\/p>\n<h3>Pitanje: Koliko vremena je potrebno za podno\u0161enje UFI i PCN obavje\u0161tenja?<\/h3>\n<p>Treba nam nekoliko dana rada. \u010cim u\u010ditate dokumentaciju, odmah po\u010dinjemo. <\/p>\n<h3>Pitanje: Da li sam ja vlasnik PCN obave\u0161tenja?<\/h3>\n<p>Da, vi ste vlasnik PCN obavijesti. Zadr\u017eavate potpuno vlasni\u0161tvo nad podacima koje ste dali.  PCN obavje\u0161tenje \u0107e biti dostupno na va\u0161em ECHA ra\u010dunu.<\/p>\n<h3>Pitanje: Da li je ova usluga za jedan ili vi\u0161e proizvoda?<\/h3>\n<p>Usluga je za jedan proizvod.<\/p>\n<h3>Pitanje: Za\u0161to moram da platim da bih napravio UFI?<\/h3>\n<p>Usluga koju nudimo nije samo pru\u017eanje UFI. UFI je komponenta u mnogo opse\u017enijem procesu.  Osnovna usluga koju pru\u017eamo je priprema i podno\u0161enje Va\u0161eg obavje\u0161tenja centra za trovanje (PCN) nacionalnim imenovanim tijelima putem ECHA portala, \u0161to je obavezan zahtjev prema EU CLP uredbi za stavljanje opasnih smjesa na tr\u017ei\u0161te. Generiranje UFI je najjednostavniji dio.  PCN izvje\u0161taj je, me\u0111utim, slo\u017een. Zahtijeva detaljan pregled sastojaka \u2013 hemijske klasifikacije \u2013 oblikovane precizno za podno\u0161enje Centra za otrove putem ECHA. <\/p>\n<h3>Pitanje: Moja kompanija nije sa sjedi\u0161tem u EU, kako mogu podnijeti PCN?<\/h3>\n<p>Pru\u017eamo rje\u0161enje za kompanije koje nemaju sjedi\u0161te u EU. Vi\u0161e informacija mo\u017eete prona\u0107i na stranici <a href=\"https:\/\/www.ufi.eu\/bs\/pcn\/izvan-eu-bs\/pcn-ufi-za-kompanije-koje-nisu-clanice-eu\/\" target=\"_blank\" rel=\"noopener\">PCN &amp; UFI za kompanije koje nisu \u010dlanice EU<\/a> . <\/p>\n<h3>Pitanje: Mo\u017eete li dostaviti sigurnosne listove u potpunosti u skladu sa EU regulativom (REACH &amp; CLP)?<\/h3>\n<p>Da, mo\u017eemo <a href=\"https:\/\/www.ufi.eu\/bs\/pcn\/sigurnosni-list\/usluga-izrade-sigurnosnog-lista-msds-sds\/\" target=\"_blank\"><strong>kreirati sigurnosne listove (SDS)<\/strong><\/a> \u2014 tako\u0111er poznate kao <strong>listove sa sigurnosnim podacima o materijalima (MSDS)<\/strong> \u2014 prilago\u0111ene va\u0161em proizvodu i u skladu s najnovijim propisima EU. Bilo da proizvodite hemijske mje\u0161avine, uvozite proizvode u EU ili distribuirate pod privatnom robnom markom, usagla\u0161eni SDS je zakonski obavezan i neophodan za sigurnu upotrebu u cijelom lancu snabdijevanja. Vi\u0161e \u0107ete prona\u0107i na stranici <a href=\"https:\/\/www.ufi.eu\/bs\/pcn\/sigurnosni-list\/usluga-izrade-sigurnosnog-lista-msds-sds\/\" target=\"_blank\">usluge kreiranja sigurnosnog lista (MSDS\/SDS)<\/a> .  <\/p>\n","protected":false},"excerpt":{"rendered":"<p>Kako funkcionira UFI kreiranje i PCN notifikacija? Nakon kupovine ove usluge, dobit \u0107ete pristup sigurnom portalu. Ovaj portal sadr\u017ei pregled svih koraka. Popunite podatke o svom proizvodu i mi \u0107emo krenuti na posao. Obavje\u0161tenje centra za trovanje i UFI Mi \u0107emo obezbijediti: Jedinstveni identifikator formule (UFI) va\u0161eg proizvoda Izvje\u0161taj centra za otrove (PCN). Registracija va\u0161eg [&hellip;]<\/p>\n","protected":false},"featured_media":21534,"template":"","meta":[],"product_brand":[],"product_cat":[1062],"product_tag":[],"class_list":["post-21533","product","type-product","status-publish","has-post-thumbnail","product_cat-medicinski-uredaji-bs","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":10264,"product_id":12512,"menu_order":0,"quantity_min":1,"quantity_max":1,"quantity_default":1,"priced_individually":true,"shipped_individually":false,"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":10265,"product_id":12522,"menu_order":1,"quantity_min":1,"quantity_max":"","quantity_default":1,"priced_individually":true,"shipped_individually":false,"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 druge medicinske ure\u0111aje - UFI<\/title>\n<meta name=\"description\" content=\"Nabavite PCN &amp; UFI za druge medicinske ure\u0111aje. 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