{"id":357,"date":"2017-09-24T19:42:09","date_gmt":"2017-09-24T17:42:09","guid":{"rendered":"http:\/\/wp.amed.net.pl\/?page_id=357"},"modified":"2026-01-21T19:37:56","modified_gmt":"2026-01-21T18:37:56","slug":"gwarancja-jakosci-amed","status":"publish","type":"page","link":"https:\/\/amed.net.pl\/index.php\/gwarancja-jakosci-amed\/","title":{"rendered":"Gwarancja Jako\u015bci AMED"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; specialty=&#8221;on&#8221; _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;3_4&#8243; specialty_columns=&#8221;3&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_row_inner _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_column_inner saved_specialty_column_type=&#8221;3_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_social_media_follow follow_button=&#8221;on&#8221; _builder_version=&#8221;4.16&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; background_layout=&#8221;dark&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_social_media_follow_network social_network=&#8221;facebook&#8221; url=&#8221;https:\/\/www.facebook.com\/AmedPolska\/&#8221; _builder_version=&#8221;4.16&#8243; background_color=&#8221;#e09900&#8243; global_colors_info=&#8221;{}&#8221; follow_button=&#8221;on&#8221; url_new_window=&#8221;on&#8221;]facebook[\/et_pb_social_media_follow_network][\/et_pb_social_media_follow][et_pb_text _builder_version=&#8221;4.16&#8243; header_font=&#8221;|700|||||||&#8221; header_text_align=&#8221;center&#8221; background_color=&#8221;rgba(188,188,188,0.29)&#8221; custom_padding=&#8221;30px||30px|&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h1>Gwarancja Jako\u015bci AMED<\/h1>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h1 style=\"text-align: center;\"><strong style=\"font-size: 14px; text-align: justify; color: #666666; font-family: Arial, Helvetica, Arial, Lucida, sans-serif;\"><span class=\"blueBold9\">GWARANCJA NAJWY\u017bSZEJ JAKO\u015aCI<\/span><\/strong><\/h1>\n<p style=\"text-align: center;\">Od momentu naszego powstania w 2000 r. realizujemy jeden z naszych podstawowych cel\u00f3w:<\/p>\n<p style=\"text-align: center;\"><strong>OFEROWANIE NAJWY\u017bSZEJ JAKO\u015aCI PRODUKT\u00d3W WYTWARZANYCH Z WYSOKIEJ KLASY SUROWC\u00d3W<\/strong><\/p>\n<p style=\"text-align: center;\">Nasza podstawowa zasada to dostarczanie wysokiej jako\u015bci produkt\u00f3w przy zastosowaniu przyjaznej dla u\u017cytkownika technologii nowej generacji. Promujemy rzeteln\u0105 i bezpieczn\u0105 opiek\u0119 nad pacjentem. Przed sprzeda\u017c\u0105, upewniamy si\u0119, \u017ce wszystkie nasze produkty s\u0105 wolne od jakichkolwiek wad i zanieczyszcze\u0144.<\/p>\n<p style=\"text-align: center;\">Nasze produkty s\u0105 bezpieczne w stosowaniu, co potwierdzaj\u0105 odpowiednie wpisy do Rejestru Wyrob\u00f3w Medycznych w Polsce oraz posiadane certyfikaty:<\/p>\n<ul style=\"text-align: center;\">\n<li>Najwy\u017csz\u0105 jako\u015b\u0107 stosowanych materia\u0142\u00f3w i komponent\u00f3w, proces\u00f3w produkcyjnych, pakowania oraz kontroli gwarantuj\u0105 posiadane Systemy Zapewnienia Jako\u015bci ISO 9001:2000 \/ ISO 13485:2004 (System Zarz\u0105dzania Jako\u015bci\u0105 dla Wyrob\u00f3w Medycznych).<\/li>\n<li>Dodatkow\u0105 gwarancj\u0105 bezpiecze\u0144stwa jest certyfikat CE potwierdzaj\u0105cy zastosowanie Dyrektywy 93\/42\/EWG i 98\/79\/EWG a tak\u017ce Rozporz\u0105dzenia MDR 2017\/745. Dzi\u0119ki posiadaniu znaku CE wszystkie oferowane przez nas produkty s\u0105 sprzedawane zar\u00f3wno w krajach Europejskich jaki i na Globalnym rynku.<\/li>\n<\/ul>\n<p style=\"text-align: center;\"><span style=\"color: #3366ff;\"><strong>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Nasze motto<\/strong>: <strong><em>AMED \u2013 Produkty na kt\u00f3rych mo\u017cesz polega\u0107. <\/em><\/strong><\/span><\/p>\n<p style=\"text-align: center;\"><span style=\"color: #3366ff;\"><strong><em>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0Wysoka Jako\u015b\u0107,\u00a0<\/em><\/strong><\/span><span style=\"color: #3366ff;\"><strong><em>Bezpiecze\u0144stwo\u00a0<\/em><\/strong><\/span><span style=\"color: #3366ff;\"><strong><em>i Dobra Cena Gwarantowane!<\/em><\/strong><\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column_inner][\/et_pb_row_inner][et_pb_row_inner _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_column_inner saved_specialty_column_type=&#8221;3_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: center;\"><strong><em>Wyci\u0105g stosowanych mi\u0119dzynarodowych norm i przepis\u00f3w w zakresie wyrob\u00f3w medycznych:<\/em><\/strong><\/p>\n<p>[\/et_pb_text][\/et_pb_column_inner][\/et_pb_row_inner][et_pb_row_inner _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221; column_structure=&#8221;1_2,1_2&#8243;][et_pb_column_inner type=&#8221;1_2&#8243; saved_specialty_column_type=&#8221;3_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><strong><\/strong><\/p>\n<p><strong>Dyrektywa 93\/42\/EWG\u00a0\u00a0<\/strong><\/p>\n<p>Dyrektywa okre\u015blaj\u0105ca zasady dotycz\u0105ce projektowania i produkcji wyrob\u00f3w medycznych, zapewniaj\u0105ca ich wysok\u0105 jako\u015b\u0107 wykonania i bezpiecze\u0144stwo stosowania. Oznakowanie \u00a0b\u0119d\u0105ce gwarancj\u0105 bezpiecze\u0144stwa produktu.<\/p>\n<p><strong>ISO 10993-3:2003<\/strong><\/p>\n<p>Norma dotycz\u0105ca biologicznej ocena wyrob\u00f3w medycznych. Badania genotoksyczno\u015bci, rakotw\u00f3rczo\u015bci i toksycznego wp\u0142ywu na rozrodczo\u015b\u0107.<\/p>\n<p><strong>ISO 10993-5:2009<\/strong><\/p>\n<p>Norma dotycz\u0105ca biologicznej oceny wyrob\u00f3w medycznych. Opisuje metody badania do oceny cytotoksyczno\u015bci in vitro w wyrobach medycznych. Metody te s\u0105 przeznaczone do okre\u015blenia odpowiedzi biologicznej kom\u00f3rek ssak\u00f3w in vitro za pomoc\u0105 odpowiednich parametr\u00f3w biologicznych.<\/p>\n<p><strong>ISO 11135-1:2007<\/strong><\/p>\n<p>Sterylizacja produkt\u00f3w stosowanych w ochronie zdrowia &#8212; Tlenek etylenu &#8212; Wymagania dotycz\u0105ce opracowywania, walidacji i rutynowej kontroli procesu sterylizacji wyrob\u00f3w medycznych.<\/p>\n<p><strong>ISO 11135-1:2006<\/strong><\/p>\n<p>Sterylizacja produkt\u00f3w stosowanych w ochronie zdrowia \u2013 Promienie Ultrafioletowe &#8212; Wymagania dotycz\u0105ce opracowywania, walidacji i rutynowej kontroli procesu sterylizacji wyrob\u00f3w medycznych.<\/p>\n<p>\u00a0<\/p>\n<p>[\/et_pb_text][\/et_pb_column_inner][et_pb_column_inner type=&#8221;1_2&#8243; saved_specialty_column_type=&#8221;3_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><strong><\/strong><\/p>\n<p><strong>Dyrektywa 98\/79\/EWG\u00a0\u00a0<\/strong><\/p>\n<p>Dyrektywa<span>\u00a0ma zastosowanie do wyrob\u00f3w medycznych u\u017cywanych do diagnozy\u00a0<\/span><em>in vitro<\/em><span>\u00a0oraz ich wyposa\u017cenia dodatkowego.<\/span><\/p>\n<p><strong>ISO 11607-1:2006<\/strong><\/p>\n<p>Norma dotycz\u0105ca opakowania dla finalnie sterylizowanych wyrob\u00f3w medycznych. Wymagania i metody badania materia\u0142\u00f3w, wst\u0119pnie uformowanych system\u00f3w bariery sterylnej, system\u00f3w bariery sterylnej i system\u00f3w opakowaniowych, kt\u00f3re s\u0105 przeznaczone do utrzymania sterylno\u015bci finalnie sterylizowanych wyrob\u00f3w medycznych a\u017c do chwili ich u\u017cycia.<\/p>\n<p><strong>ISO 13485:2003<\/strong><\/p>\n<p>Wyroby medyczne &#8212; Systemy zarz\u0105dzania jako\u015bci\u0105. Wymagania dotycz\u0105ce systemu zarz\u0105dzania jako\u015bci\u0105, zapewniaj\u0105ca, \u017ce producent wprowadza na rynek wyroby medyczne spe\u0142niaj\u0105ce wymagania klienta i wymagania przepis\u00f3w maj\u0105cych zastosowanie do wyrob\u00f3w medycznych i zwi\u0105zanych z nimi us\u0142ug.<\/p>\n<p><strong>ISO 9001:2008<\/strong><\/p>\n<p>Systemy zarz\u0105dzania jako\u015bci\u0105. Wymagania dotycz\u0105ce system\u00f3w zarz\u0105dzania jako\u015bci\u0105, zapewniaj\u0105ca, \u017ce dostarczane przez producenta wyroby medyczne spe\u0142niaj\u0105 wymagania klienta i wymagania maj\u0105cych zastosowanie przepis\u00f3w oraz, \u017ce producent d\u0105\u017cy do zwi\u0119kszenia zadowolenia klienta przez skuteczne stosowanie systemu, \u0142\u0105cznie z procesami dotycz\u0105cymi ci\u0105g\u0142ego doskonalenia systemu i zapewnienia zgodno\u015bci z wymaganiami klienta i wymaganiami maj\u0105cymi zastosowanie przepis\u00f3w.<\/p>\n<p>[\/et_pb_text][\/et_pb_column_inner][\/et_pb_row_inner][\/et_pb_column][et_pb_column type=&#8221;1_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_search exclude_pages=&#8221;off&#8221; _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221; button_text_size__hover_enabled=&#8221;off&#8221; button_one_text_size__hover_enabled=&#8221;off&#8221; 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Przed sprzeda\u017c\u0105, upewniamy si\u0119, \u017ce [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-357","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Gwarancja Jako\u015bci AMED - amed.net.pl<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/amed.net.pl\/index.php\/gwarancja-jakosci-amed\/\" \/>\n<meta property=\"og:locale\" content=\"pl_PL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Gwarancja Jako\u015bci AMED - amed.net.pl\" \/>\n<meta property=\"og:description\" content=\"Gwarancja Jako\u015bci AMEDGWARANCJA NAJWY\u017bSZEJ JAKO\u015aCI Od momentu naszego powstania w 2000 r. realizujemy jeden z naszych podstawowych cel\u00f3w: OFEROWANIE NAJWY\u017bSZEJ JAKO\u015aCI PRODUKT\u00d3W WYTWARZANYCH Z WYSOKIEJ KLASY SUROWC\u00d3W Nasza podstawowa zasada to dostarczanie wysokiej jako\u015bci produkt\u00f3w przy zastosowaniu przyjaznej dla u\u017cytkownika technologii nowej generacji. 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