{"id":21419,"date":"2025-03-20T08:25:25","date_gmt":"2025-04-17T09:43:39","guid":{"rendered":"https:\/\/www.ufi.eu\/pcn\/be-kategorijos\/medicinos-prietaisu-valymo-priemoniu-pcn-ir-ufi-es-2017-745\/"},"modified":"2025-04-17T09:43:39","modified_gmt":"2025-04-17T09:43:39","slug":"medicinos-prietaisu-valymo-priemoniu-pcn-ir-ufi-es-2017-745","status":"publish","type":"product","link":"https:\/\/www.ufi.eu\/lt\/product\/medicinos-prietaisu-valymo-priemoniu-pcn-ir-ufi-es-2017-745\/","title":{"rendered":"Medicinos prietais\u0173 valymo priemoni\u0173 PCN ir UFI (ES 2017\/745)"},"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 medicinos prietaisus<\/h2>\n<p>Medicinos prietaisai, kaip apibr\u0117\u017eta Europos Parlamento ir Tarybos reglamente (ES) 2017\/745, turi atitikti ES reglamentus, kad b\u016bt\u0173 u\u017etikrinta j\u0173 sauga ir tinkamas naudojimas sveikatos prie\u017ei\u016bros \u012fstaigose. Medicinos prietaisams, kuri\u0173 sud\u0117tyje yra pavojing\u0173 med\u017eiag\u0173, b\u016btina pateikti prane\u0161im\u0105 apsinuodijim\u0173 centrui (PCN), kad b\u016bt\u0173 pateikta i\u0161sami saugos informacija avarinio poveikio atveju. \u0160iuo prane\u0161imu u\u017etikrinama, kad pagalbos tarnybos ir sveikatos prie\u017ei\u016bros specialistai gal\u0117t\u0173 imtis tinkam\u0173 veiksm\u0173 atsitiktinio poveikio atveju, padedant i\u0161vengti \u017ealos pacientams ir naudotojams.  <\/p>\n<h3>Kas yra UFI?<\/h3>\n<p>Unikalios formul\u0117s identifikatorius (UFI) &#8211; tai kodas, priskiriamas chemini\u0173 med\u017eiag\u0173 mi\u0161iniui, pavyzd\u017eiui, naudojamam medicinos prietaisuose, kuriuose yra pavojing\u0173 med\u017eiag\u0173. UFI leid\u017eia skubios pagalbos tarnyboms greitai nustatyti konkre\u010di\u0105 gaminio chemin\u0119 sud\u0117t\u012f, o tai padeda operatyviai likviduoti bet kokius poveikio incidentus. UFI nurodomas gaminio etiket\u0117je, kad \u0161i\u0105 svarbi\u0105 informacij\u0105 b\u016bt\u0173 galima gauti i\u0161 karto.  <\/p>\n<h3>Kas yra PCN?<\/h3>\n<p>Prane\u0161imas apsinuodijim\u0173 centrui (PCN) &#8211; tai gamintoj\u0173 pateikiamas prane\u0161imas, kuriame pateikiama i\u0161sami informacija apie pavojingas produkto savybes. Medicinos prietais\u0173 atveju PCN pateikiami duomenys apie gaminyje esan\u010dias chemines med\u017eiagas, j\u0173 klasifikacij\u0105 pagal CLP reglament\u0105 ir b\u016btinas pirmosios pagalbos priemones. PCN padeda skubios pagalbos tarnyboms gauti svarbi\u0105 saugos informacij\u0105, jei prietaiso chemin\u0117s med\u017eiagos paveikt\u0173 prietais\u0105.  <\/p>\n<h3>Kas yra CLP?<\/h3>\n<p>Klasifikavimo, \u017eenklinimo ir pakavimo (CLP) reglamente nustatyta pavojing\u0173 chemini\u0173 med\u017eiag\u0173 ir mi\u0161ini\u0173 klasifikavimo sistema. Juo reikalaujama, kad gaminiai, \u012fskaitant medicinos prietaisus su chemin\u0117mis med\u017eiagomis, b\u016bt\u0173 ai\u0161kiai pa\u017eenklinti pavojingumo simboliais, signaliniais \u017eod\u017eiais ir atsargumo fraz\u0117mis. \u0160iuo reglamentu u\u017etikrinama, kad naudotojai ir avarini\u0173 tarnyb\u0173 darbuotojai \u017einot\u0173 apie rizik\u0105 ir \u017einot\u0173, kaip saugiai elgtis su gaminiu \u012fvykus nelaimingam atsitikimui.  <\/p>\n<h3>Kas yra Apsinuodijim\u0173 centras?<\/h3>\n<p>Apsinuodijim\u0173 centras &#8211; tai nacionalini\u0173 apsinuodijim\u0173 centr\u0173 tinklas, atsakingas u\u017e informacijos apie pavojingas med\u017eiagas ir mi\u0161inius rinkim\u0105, tvarkym\u0105 ir sklaid\u0105. Gamintojai privalo u\u017eregistruoti savo pavojingus gaminius Apsinuodijim\u0173 centre, kad b\u016bt\u0173 u\u017etikrinta, jog apsinuodijimo ar s\u0105ly\u010dio atveju sveikatos prie\u017ei\u016bros specialistai ir skubios pagalbos tarnybos visoje ES gal\u0117t\u0173 lengvai gauti svarbi\u0105 saugos informacij\u0105. <\/p>\n<h3>Kod\u0117l to reikia?<\/h3>\n<p>PCN yra labai svarbus siekiant u\u017etikrinti, kad reaguojantieji \u012f skubius atvejus laiku gaut\u0173 tiksli\u0105 informacij\u0105 apie medicinos prietaisuose esan\u010dias pavojingas med\u017eiagas. Susid\u016brus su kenksmingomis chemin\u0117mis med\u017eiagomis, PCN leid\u017eia grei\u010diau ir veiksmingiau \u012fsiki\u0161ti, taip suma\u017einant su\u017eeidim\u0173 ar mirties rizik\u0105. PCN pateikimas padeda apsaugoti naudotoj\u0173 ir pacient\u0173 saug\u0105, nes padeda veiksmingiau atlikti skubios pagalbos proced\u016bras ir u\u017etikrinti atitikt\u012f ES reglamentams.  <\/p>\n<h3>Nuo kada tai privaloma pagal \u012fstatym\u0105?<\/h3>\n<p>Reikalavimas pateikti PCN medicinos prietaisams, kuriuose yra pavojing\u0173 med\u017eiag\u0173, \u012fsigaliojo 2021 m. sausio 1 d. Pagal ES CLP reglament\u0105 (VIII pried\u0105) gamintojai privalo prane\u0161ti Apsinuodijim\u0173 centrui apie visus pavojingus mi\u0161inius, \u012fskaitant medicinos prietaisuose naudojamus mi\u0161inius. \u0160is reglamentas yra dalis nuolatini\u0173 pastang\u0173 u\u017etikrinti gamini\u0173 saug\u0105 ir pagerinti reagavim\u0105 \u012f ekstremalias situacijas visoje ES.  <\/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, privalote pateikti prane\u0161im\u0105 apie apsinuodijimus (PCN). Taip u\u017etikrinama, kad skubios pagalbos tarnybos tur\u0117t\u0173 reikiam\u0105 informacij\u0105, reikaling\u0105 reaguoti \u012f nelaimingus atsitikimus ar poveikio incidentus, susijusius su prietaisu. <\/p>\n<h3>Klausimas: Koki\u0105 informacij\u0105 reikia pateikti teikiant PCN?<\/h3>\n<p>Atsakymas: Pateiktame PCN pateikiama i\u0161sami informacija apie gaminyje esan\u010dias chemines med\u017eiagas, j\u0173 klasifikacij\u0105 pagal CLP reglament\u0105, reagavimo \u012f ekstremalias situacijas priemones ir UFI. \u0160i informacija padeda avarij\u0173 likvidavimo darbuotojams greitai ir tiksliai \u012fvertinti situacij\u0105 poveikio atveju. <\/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, galb\u016bt, j\u016bs\u0173 produktas gali b\u016bti pa\u0161alintas i\u0161 rinkos. Be to, avarini\u0173 tarnyb\u0173 pareig\u016bnams gali tr\u016bkti svarbios informacijos, kad jie gal\u0117t\u0173 veiksmingai valdyti poveikio incidentus, o tai gali tur\u0117ti sunki\u0173 pasekmi\u0173 sveikatai. <\/p>\n<h3>Klausimas: Kaip pateikti PCN d\u0117l savo medicinos prietaiso?<\/h3>\n<p>Atsakymas: Nor\u0117dami pateikti PCN, tur\u0117site pateikti UFI, CLP reikalavimus atitinkan\u010di\u0105 gaminio etiket\u0119 ir i\u0161sami\u0105 informacij\u0105 apie prietaiso sud\u0117tyje esan\u010dias pavojingas chemines med\u017eiagas. M\u016bs\u0173 \u012fmon\u0117 gali pad\u0117ti jums parengti reikiamus dokumentus ir pateikti juos Apsinuodijim\u0173 centrui, kad b\u016bt\u0173 u\u017etikrinta atitiktis reikalavimams. <\/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":21420,"template":"","meta":[],"product_brand":[],"product_cat":[1022],"product_tag":[],"class_list":{"0":"post-21419","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":10150,"product_id":12549,"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":10151,"product_id":12536,"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>Medicinos prietais\u0173 valymo priemoni\u0173 PCN ir UFI (ES 2017\/745) - UFI<\/title>\n<meta name=\"description\" content=\"Gaukite PCN ir UFI medicinos prietaisams pagal ES reglament\u0105 2017\/745. 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