{"id":21129,"date":"2025-03-20T08:25:24","date_gmt":"2025-04-17T09:39:52","guid":{"rendered":"https:\/\/www.ufi.eu\/pcn\/be-kategorijos\/pcn-ir-ufi-kitiems-medicinos-prietaisams\/"},"modified":"2025-04-17T09:39:52","modified_gmt":"2025-04-17T09:39:52","slug":"pcn-ir-ufi-kitiems-medicinos-prietaisams","status":"publish","type":"product","link":"https:\/\/www.ufi.eu\/lt\/product\/pcn-ir-ufi-kitiems-medicinos-prietaisams\/","title":{"rendered":"PCN ir UFI kitiems medicinos prietaisams"},"content":{"rendered":"<h2>Kaip veikia UFI k\u016brimo ir prane\u0161imo apie PCN paslauga?<\/h2>\n<p>\u012esigij\u0119 \u0161i\u0105 paslaug\u0105, gausite prieig\u0105 prie saugaus portalo. \u0160iame portale pateikiama vis\u0173 \u017eingsni\u0173 ap\u017evalga.  U\u017epildykite gaminio informacij\u0105 ir mes imsim\u0117s darbo.<\/p>\n<h3>Prane\u0161imas apie apsinuodijim\u0173 centr\u0105 ir UFI<\/h3>\n<p>Mes suteiksime:<\/p>\n<ul>\n<li>J\u016bs\u0173 gaminio unikalus formul\u0117s identifikatorius (UFI)<\/li>\n<li>Prane\u0161imas apie apsinuodijim\u0173 centro prane\u0161im\u0105 (PCN)<\/li>\n<li>J\u016bs\u0173 gaminio registracija atitinkamuose nacionaliniuose apsinuodijim\u0173 centruose per ECHA.<\/li>\n<\/ul>\n<h3>PCN registracijos \u0161alys<\/h3>\n<p>Galite suskai\u010diuoti \u0161ali\u0173, kuriose norite u\u017eregistruoti savo gamin\u012f, skai\u010di\u0173. Tai yra \u0161ali\u0173, kurias turite \u012fsigyti, skai\u010dius.  Portale gal\u0117site pasirinkti konkre\u010dias \u0161alis. Jei v\u0117liau planuojate i\u0161pl\u0117sti savo gamini\u0173 pardavim\u0105 \u012f naujas \u0161alis, visada galite u\u017esisakyti papildom\u0173 <a href=\"https:\/\/www.ufi.eu\/lt\/pcn\/salys\/pcn-registracijos-salys\/\" target=\"_blank\" title=\"PCN \u0161ali\u0173 registracijos\">PCN \u0161ali\u0173 registracij\u0173<\/a>.<br \/>ES yra 27 \u0161alys, o EEE &#8211; 30 (ES + Lichten\u0161teinas, Norvegija ir Islandija) Portale galite pasirinkti \u0161ias \u0161alis: <\/p>\n<table cellpadding=\"2\" cellspacing=\"0\" border=\"1\">\n<tbody>\n<tr>\n<td>Belgija<\/td>\n<td>(BE)<\/td>\n<td>Ispanija<\/td>\n<td>(ES)<\/td>\n<td>Vengrija<\/td>\n<td>(HU)<\/td>\n<td>Slovakija<\/td>\n<td>(SK)<\/td>\n<\/tr>\n<tr>\n<td>Bulgarija<\/td>\n<td>(BG)<\/td>\n<td>Pranc\u016bzija<\/td>\n<td>(FR)<\/td>\n<td>Malta<\/td>\n<td>(MT)<\/td>\n<td>Suomija<\/td>\n<td>(FI)<\/td>\n<\/tr>\n<tr>\n<td>\u010cekija<\/td>\n<td>(CZ)<\/td>\n<td>Kroatija<\/td>\n<td>(HR)<\/td>\n<td>Nyderlandai<\/td>\n<td>(NL)<\/td>\n<td>\u0160vedija<\/td>\n<td>(SE)<\/td>\n<\/tr>\n<tr>\n<td>Danija<\/td>\n<td>(DK)<\/td>\n<td>Italija<\/td>\n<td>(IT)<\/td>\n<td>Austrija<\/td>\n<td>(AT)<\/td>\n<td>Vokietija<\/td>\n<td>(DE)<\/td>\n<\/tr>\n<tr>\n<td>Kipras<\/td>\n<td>(CY)<\/td>\n<td>Lenkija<\/td>\n<td>(PL)<\/td>\n<td>Islandija<\/td>\n<td>(IS)<\/td>\n<td>Estija<\/td>\n<td>(EE)<\/td>\n<\/tr>\n<tr>\n<td>Latvija<\/td>\n<td>(LV)<\/td>\n<td>Portugalija<\/td>\n<td>(PT)<\/td>\n<td>Lichten\u0161teinas<\/td>\n<td>(LI)<\/td>\n<td>Airija<\/td>\n<td>(IE)<\/td>\n<\/tr>\n<tr>\n<td>Lietuva<\/td>\n<td>(LT)<\/td>\n<td>Rumunija<\/td>\n<td>(RO)<\/td>\n<td>Norvegija<\/td>\n<td>(NE)<\/td>\n<td>Graikija<\/td>\n<td>(EL)<\/td>\n<\/tr>\n<tr>\n<td>Liuksemburgas<\/td>\n<td>(LU)<\/td>\n<td>Slov\u0117nija<\/td>\n<td>(SI)<\/td>\n<td>\u0160veicarija*<\/td>\n<td>(CH)<\/td>\n<td><\/td>\n<td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>*\u0160veicarijai galime sukurti PCN byl\u0105 su visa reikiama informacija, kad gal\u0117tum\u0117te pateikti parai\u0161k\u0105 \u0160veicarijos portale. Susisiekite su mumis d\u0117l daugiau informacijos. <\/p>\n<h3>CLP etiket\u0117s informacija<\/h3>\n<p>Si\u016blome galimyb\u0119 \u012fsigyti CLP reikalavimus atitinkan\u010di\u0105 gaminio etiket\u0119, kurioje pateikiama visa privaloma informacija, kaip reikalaujama pagal ES CLP reglament\u0105. Ji bus pateikta PDF formatu.  Tai n\u0117ra projektas, o reikalingos informacijos santrauka. Taip gal\u0117site \u012ftraukti reikiam\u0105 informacij\u0105 \u012f gaminio etiket\u0117s dizain\u0105. <a href=\"https:\/\/www.ufi.eu\/lt\/pcn\/clp-etikete\/clp-etiketes-kurimas-ir-atitikties-patikra\/\" target=\"_blank\" title=\"CLP etiket\u0117Creation\">CLP etiket\u0117s k\u016brim\u0105<\/a> taip pat galite u\u017esisakyti atskirai. Jau turite etiket\u0119? &#8211; Galime atlikti j\u016bs\u0173 <a href=\"https:\/\/www.ufi.eu\/lt\/pcn\/clp-etikete\/clp-etiketes-kurimas-ir-atitikties-patikra\/\" target=\"_blank\" title=\"CLP etiket\u0117s atitikties patikra\">etiket\u0117s atitikties CLP reikalavimams patikrinim\u0105<\/a> pagal galiojan\u010dius CLP reikalavimus. Pateiksime i\u0161samias pastabas ir pataisymus, kad j\u016bs\u0173 etiket\u0117 atitikt\u0173 visus teis\u0117s akt\u0173 reikalavimus.     <\/p>\n<h2>Prane\u0161imas apsinuodijim\u0173 centrui apie kitus medicinos prietaisus<\/h2>\n<p>Kiti medicinos prietaisai, kurie nepriskiriami konkre\u010dioms kategorijoms, pavyzd\u017eiui, valymo ar dezinfekavimo priemon\u0117s, vis tiek turi atitikti ES reglamentus, jei juose yra pavojing\u0173 med\u017eiag\u0173. Siekiant u\u017etikrinti, kad skubios pagalbos tarnybos ir sveikatos prie\u017ei\u016bros specialistai gal\u0117t\u0173 greitai imtis veiksm\u0173 poveikio ar apsinuodijimo atveju, b\u016btina pateikti prane\u0161im\u0105 apsinuodijim\u0173 centrui (PCN). Pateikdami PCN, gamintojai pateikia svarbi\u0105 saugos informacij\u0105 apie j\u0173 medicinos prietais\u0173 chemines sudedam\u0105sias dalis ir taip padeda apsaugoti naudotoj\u0173 ir pacient\u0173 sveikat\u0105 bei saug\u0105.  <\/p>\n<h3>Kas yra UFI?<\/h3>\n<p>Unikalios formul\u0117s identifikatorius (UFI) &#8211; tai kodas, naudojamas konkre\u010dioms chemini\u0173 med\u017eiag\u0173 formul\u0117ms produktuose identifikuoti. Medicinos prietais\u0173 atveju UFI naudojamas siekiant skubios pagalbos tarnyboms suteikti i\u0161sami\u0105, konkre\u010diam gaminiui b\u016bding\u0105 informacij\u0105 apie chemini\u0173 med\u017eiag\u0173 sud\u0117t\u012f. Taip reaguotojai gali nustatyti tiksl\u0173 mi\u0161in\u012f ir imtis tinkam\u0173 veiksm\u0173 avarijos atveju.  <\/p>\n<h3>Kas yra PCN?<\/h3>\n<p>Prane\u0161imas apsinuodijim\u0173 centrui (PCN) &#8211; tai prane\u0161imas, kur\u012f gamintojai privalo pateikti apsinuodijim\u0173 centrams. Jame pateikiama labai svarbi informacija apie pavojingas gamini\u0173, \u012fskaitant medicinos prietaisuose naudojamas chemines med\u017eiagas, savybes. PCN pateikiama pavojingumo klasifikacija, pirmosios pagalbos priemon\u0117s ir kita informacija apie reagavim\u0105 \u012f ekstremalias situacijas. \u0160i informacija labai svarbi sveikatos prie\u017ei\u016bros specialistams ir skubios pagalbos darbuotojams, kad jie gal\u0117t\u0173 veiksmingai valdyti chemini\u0173 med\u017eiag\u0173 poveikio incidentus.   <\/p>\n<h3>Kas yra CLP?<\/h3>\n<p>Klasifikavimo, \u017eenklinimo ir pakavimo (CLP) reglamente nustatyti chemini\u0173 med\u017eiag\u0173 ir mi\u0161ini\u0173 klasifikavimo kriterijai. Juo u\u017etikrinama, kad gaminiai, \u012fskaitant medicinos prietaisus, kuriuose yra pavojing\u0173 med\u017eiag\u0173, b\u016bt\u0173 ai\u0161kiai pa\u017eenklinti pavojingumo simboliais, atsargumo fraz\u0117mis ir pirmosios pagalbos instrukcijomis. CLP reglamente numatytas standartizuotas b\u016bdas informuoti apie chemini\u0173 med\u017eiag\u0173 keliamus pavojus visoje ES, u\u017etikrinant saug\u0105 ir informuotum\u0105 visais lygmenimis.  <\/p>\n<h3>Kas yra Apsinuodijim\u0173 centras?<\/h3>\n<p>Apsinuodijim\u0173 centras &#8211; tai nacionalini\u0173 apsinuodijim\u0173 kontrol\u0117s centr\u0173, kurie renka, apdoroja ir teikia informacij\u0105 apie pavojingas chemines med\u017eiagas, tinklas. Pavojing\u0173 medicinos prietais\u0173 gamintojai privalo registruoti savo gaminius Apsinuodijim\u0173 centre, kad saugos informacija b\u016bt\u0173 galima dalytis su sveikatos prie\u017ei\u016bros paslaug\u0173 teik\u0117jais ir skubios pagalbos tarnybomis. Taip u\u017etikrinamas greitas ir koordinuotas reagavimas chemini\u0173 med\u017eiag\u0173 poveikio atveju.  <\/p>\n<h3>Kod\u0117l to reikia?<\/h3>\n<p>Medicinos prietaisuose gali b\u016bti chemini\u0173 med\u017eiag\u0173, kurios kelia pavoj\u0173 naudotojams ar pacientams, jei atsitiktinai su jomis susiduriama. PCN pateikimas padeda u\u017etikrinti, kad reaguojantys \u012f avarijas ir sveikatos prie\u017ei\u016bros specialistai tur\u0117t\u0173 galimyb\u0119 nedelsiant gauti svarbi\u0105 saugos informacij\u0105, jei \u012fvykt\u0173 susid\u016brimas. Tokia greita prieiga gali tur\u0117ti lemiamos reik\u0161m\u0117s u\u017ekertant keli\u0105 \u017ealai arba j\u0105 suma\u017einant, u\u017etikrinant, kad medicinos prietaisai b\u016bt\u0173 naudojami saugiai.  <\/p>\n<h3>Nuo kada tai privaloma pagal \u012fstatym\u0105?<\/h3>\n<p>Nuo 2021 m. sausio 1 d. medicinos prietais\u0173, kuri\u0173 sud\u0117tyje yra pavojing\u0173 chemini\u0173 med\u017eiag\u0173, gamintojams taikomas teisinis reikalavimas pateikti prane\u0161im\u0105 apie apsinuodijimus (PCN). \u0160i prievol\u0117 kyla i\u0161 ES CLP reglamento, kuriuo siekiama visoje Europos S\u0105jungoje patobulinti pavojing\u0173 produkt\u0173 saugos standartus ir reagavimo proced\u016bras. \u0160io teis\u0117s akto laikymasis yra b\u016btinas patekimui \u012f rink\u0105 ir vartotoj\u0173 apsaugai.  <\/p>\n<h2>DUK<\/h2>\n<h3>Klausimas: Ar turiu pateikti PCN d\u0117l savo medicinos prietaiso?<\/h3>\n<p>Atsakymas: Taip, jei j\u016bs\u0173 medicinos prietaiso sud\u0117tyje yra pavojing\u0173 chemini\u0173 med\u017eiag\u0173, b\u016btina pateikti PCN. Taip u\u017etikrinama, kad skubios pagalbos tarnybos gal\u0117t\u0173 gauti svarbi\u0105 informacij\u0105 apie j\u016bs\u0173 gaminyje esan\u010dias chemines med\u017eiagas, o tai padidint\u0173 saugum\u0105 poveikio atveju. <\/p>\n<h3>Klausimas: Kokia informacija turi b\u016bti pateikta mano medicinos prietaiso PCN?<\/h3>\n<p>Atsakymas: \u012e j\u016bs\u0173 medicinos prietaiso PCN turi b\u016bti \u012ftraukta informacija apie jame esan\u010dias pavojingas chemines med\u017eiagas, j\u0173 klasifikacij\u0105 pagal CLP, avarinio reagavimo priemones ir UFI. Labai svarbu u\u017etikrinti, kad informacija b\u016bt\u0173 tiksli ir atitikt\u0173 ES reglamentus. <\/p>\n<h3>Klausimas: Kas atsitiks, jei nepateiksiu PCN d\u0117l savo medicinos prietaiso?<\/h3>\n<p>Atsakymas: Nepateikus PCN, gali b\u016bti skirtos baudos, nuobaudos ir produktas gali b\u016bti pa\u0161alintas i\u0161 rinkos. Be to, avarij\u0173 likvidavimo tarnyboms gali tr\u016bkti svarbios informacijos, reikalingos poveikio incidentams valdyti, o tai gali sukelti sunki\u0173 padarini\u0173 sveikatai. <\/p>\n<h3>Klausimas: Kaip galiu pateikti PCN d\u0117l savo medicinos prietaiso?<\/h3>\n<p>Atsakymas: Nor\u0117dami pateikti PCN, tur\u0117site surinkti b\u016btinus saugos duomenis, \u012fskaitant UFI, CLP reikalavimus atitinkan\u010di\u0105 gaminio etiket\u0119 ir pavojingumo klasifikacij\u0105. M\u016bs\u0173 \u012fmon\u0117 si\u016blo paslaugas, pad\u0117sian\u010dias jums parengti prane\u0161im\u0105 apie gamin\u012f ir pateikti j\u012f Apsinuodijim\u0173 centrui, kad jis atitikt\u0173 reikalavimus. <\/p>\n<h3>Klausimas: Kiek laiko u\u017etrunka pateikti UFI ir PCN prane\u0161im\u0105?<\/h3>\n<p>Mums prireiks keli\u0173 dien\u0173 darbo. Kai tik \u012fkelsite dokumentus, i\u0161 karto prad\u0117sime darb\u0105. <\/p>\n<h3>Klausimas: Ar a\u0161 esu PCN prane\u0161imo savininkas?<\/h3>\n<p>Taip, j\u016bs esate prane\u0161imo apie PCN savininkas. Jums i\u0161lieka visa j\u016bs\u0173 pateikt\u0173 duomen\u0173 nuosavyb\u0117.  PCN prane\u0161im\u0105 gal\u0117site rasti savo ECHA paskyroje.<\/p>\n<h3>Klausimas: Ar \u0161i paslauga skirta vienam produktui, ar daugiau?<\/h3>\n<p>Paslauga teikiama vienam produktui.<\/p>\n<h3>Klausimas: Kod\u0117l turiu mok\u0117ti u\u017e UFI suk\u016brim\u0105?<\/h3>\n<p>M\u016bs\u0173 si\u016bloma paslauga &#8211; tai ne tik UFI teikimas. UFI yra daug platesnio proceso sudedamoji dalis.  Pagrindin\u0117 m\u016bs\u0173 teikiama paslauga &#8211; tai prane\u0161imo apie apsinuodijim\u0105 (PCN) parengimas ir pateikimas nacionalin\u0117ms paskirtoms \u012fstaigoms per ECHA portal\u0105, kuris yra privalomas reikalavimas pagal ES CLP reglament\u0105 teikiant pavojingus mi\u0161inius \u012f rink\u0105. UFI parengimas yra papras\u010diausia dalis.  Ta\u010diau PCN ataskaita yra sud\u0117tinga. Joje reikalaujama i\u0161samios sudedam\u0173j\u0173 dali\u0173 ap\u017evalgos &#8211; chemini\u0173 med\u017eiag\u0173 klasifikacijos, kuri turi b\u016bti tiksliai suformatuota, kad b\u016bt\u0173 pateikta apsinuodijim\u0173 centrui per ECHA. <\/p>\n<h3>Klausimas: Kaip galiu pateikti PKN?<\/h3>\n<p>Si\u016blome sprendim\u0105 \u012fmon\u0117ms, kurios n\u0117ra \u012fsik\u016brusios ES. Daugiau informacijos rasite <a href=\"https:\/\/www.ufi.eu\/lt\/pcn\/uz-es-ribu\/pcn-ir-ufi-ne-es-bendrovems\/\" target=\"_blank\" rel=\"noopener\">PCN ir UFI ne ES \u012fmon\u0117ms skirtame<\/a> puslapyje. <\/p>\n<h3>Klausimas: Ar galite pateikti saugos duomen\u0173 lapus, visi\u0161kai atitinkan\u010dius ES reglament\u0105 (REACH ir CLP)?<\/h3>\n<p>Taip, galime <a href=\"https:\/\/www.ufi.eu\/lt\/pcn\/saugos-duomenu-lapas\/saugos-duomenu-lapu-msds-sds-kurimo-paslauga\/\" target=\"_blank\"><strong>sukurti saugos duomen\u0173 lapus (SDS)<\/strong><\/a>&#8211; dar vadinamus <strong>med\u017eiag\u0173 saugos duomen\u0173 lapais (MSDS)<\/strong>&#8211; pritaikytus j\u016bs\u0173 gaminiui ir atitinkan\u010dius naujausius ES reglamentus. Nesvarbu, ar gaminate cheminius mi\u0161inius, importuojate produktus \u012f ES, ar platinate juos su priva\u010dia etikete, teis\u0117s aktais reikalaujami ir saugiam naudojimui visoje tiekimo grandin\u0117je b\u016btini reikalavimus atitinkantys SDS. Daugiau informacijos rasite <a href=\"https:\/\/www.ufi.eu\/lt\/pcn\/saugos-duomenu-lapas\/saugos-duomenu-lapu-msds-sds-kurimo-paslauga\/\" target=\"_blank\">Saugos duomen\u0173 lap\u0173 (MSDS\/SDS) k\u016brimo paslaugos<\/a> puslapyje.  <\/p>\n","protected":false},"excerpt":{"rendered":"<p>Kaip veikia UFI k\u016brimo ir prane\u0161imo apie PCN paslauga? \u012esigij\u0119 \u0161i\u0105 paslaug\u0105, gausite prieig\u0105 prie saugaus portalo. \u0160iame portale pateikiama vis\u0173 \u017eingsni\u0173 ap\u017evalga. U\u017epildykite gaminio informacij\u0105 ir mes imsim\u0117s darbo. Prane\u0161imas apie apsinuodijim\u0173 centr\u0105 ir UFI Mes suteiksime: J\u016bs\u0173 gaminio unikalus formul\u0117s identifikatorius (UFI) Prane\u0161imas apie apsinuodijim\u0173 centro prane\u0161im\u0105 (PCN) J\u016bs\u0173 gaminio registracija atitinkamuose nacionaliniuose [&hellip;]<\/p>\n","protected":false},"featured_media":21130,"template":"","meta":[],"product_brand":[],"product_cat":[1022],"product_tag":[],"class_list":{"0":"post-21129","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-medicinos-prietaisai","8":"first","9":"instock","10":"virtual","11":"taxable","12":"purchasable","13":"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":9860,"product_id":12549,"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":9861,"product_id":12536,"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 ir UFI kitiems medicinos prietaisams - UFI<\/title>\n<meta name=\"description\" content=\"Gaukite PCN ir UFI kitiems medicinos prietaisams. U\u017etikrinkite ES apsinuodijim\u0173 centro atitikt\u012f ES teis\u0117s aktams, naudodamiesi m\u016bs\u0173 greita ir patikima prane\u0161imo paslauga!\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.ufi.eu\/lt\/product\/pcn-ir-ufi-kitiems-medicinos-prietaisams\/\" \/>\n<meta property=\"og:locale\" content=\"lt_LT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PCN ir UFI kitiems medicinos prietaisams\" \/>\n<meta property=\"og:description\" content=\"Gaukite PCN ir UFI kitiems medicinos prietaisams. 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