{"id":4207,"date":"2020-05-14T13:38:22","date_gmt":"2020-05-14T11:38:22","guid":{"rendered":"https:\/\/spilerdug.dk.web05.webtohosting.dk\/?page_id=4207"},"modified":"2024-07-01T10:43:21","modified_gmt":"2024-07-01T08:43:21","slug":"certificering-af-alseat","status":"publish","type":"page","link":"https:\/\/spilerdug.dk\/sv\/om-os\/certificering-og-maerkning\/certificering-af-alseat\/","title":{"rendered":"Certificering av Alseat"},"content":{"rendered":"<style>.kb-row-layout-id4207_ce3214-1b > .kt-row-column-wrap{align-content:start;}:where(.kb-row-layout-id4207_ce3214-1b > .kt-row-column-wrap) > .wp-block-kadence-column{justify-content:start;}.kb-row-layout-id4207_ce3214-1b > .kt-row-column-wrap{column-gap:var(--global-kb-gap-md, 2rem);row-gap:var(--global-kb-gap-md, 2rem);max-width:var( --global-content-width, 1400px );padding-left:var(--global-content-edge-padding);padding-right:var(--global-content-edge-padding);padding-top:var(--global-kb-spacing-3xl, 6.5rem);padding-bottom:var(--global-kb-spacing-3xl, 6.5rem);grid-template-columns:minmax(0, calc(35% - ((var(--global-kb-gap-md, 2rem) * 1 )\/2)))minmax(0, calc(65% - ((var(--global-kb-gap-md, 2rem) * 1 )\/2)));}.kb-row-layout-id4207_ce3214-1b > .kt-row-layout-overlay{opacity:0.30;}@media all and (max-width: 1024px){.kb-row-layout-id4207_ce3214-1b > .kt-row-column-wrap{padding-top:var(--global-kb-spacing-xxl, 5rem);padding-bottom:var(--global-kb-spacing-xxl, 5rem);grid-template-columns:repeat(2, minmax(0, 1fr));}}@media all and (max-width: 767px){.kb-row-layout-id4207_ce3214-1b > .kt-row-column-wrap{padding-top:var(--global-kb-spacing-lg, 3rem);padding-bottom:var(--global-kb-spacing-lg, 3rem);grid-template-columns:minmax(0, 1fr);}}<\/style><div class=\"kb-row-layout-wrap kb-row-layout-id4207_ce3214-1b alignnone wp-block-kadence-rowlayout\"><div class=\"kt-row-column-wrap kt-has-2-columns kt-row-layout-equal kt-tab-layout-inherit kt-mobile-layout-row kt-row-valign-top kb-theme-content-width\">\n<style>.kadence-column4207_9b3a2d-c2 > .kt-inside-inner-col,.kadence-column4207_9b3a2d-c2 > .kt-inside-inner-col:before{border-top-left-radius:0px;border-top-right-radius:0px;border-bottom-right-radius:0px;border-bottom-left-radius:0px;}.kadence-column4207_9b3a2d-c2 > .kt-inside-inner-col{column-gap:var(--global-kb-gap-sm, 1rem);}.kadence-column4207_9b3a2d-c2 > .kt-inside-inner-col{flex-direction:column;}.kadence-column4207_9b3a2d-c2 > .kt-inside-inner-col > .aligncenter{width:100%;}.kadence-column4207_9b3a2d-c2 > .kt-inside-inner-col:before{opacity:0.3;}.kadence-column4207_9b3a2d-c2{position:relative;}@media all and (max-width: 1024px){.kadence-column4207_9b3a2d-c2 > .kt-inside-inner-col{flex-direction:column;justify-content:center;}}@media all and (max-width: 767px){.kadence-column4207_9b3a2d-c2 > .kt-inside-inner-col{flex-direction:column;justify-content:center;}}<\/style>\n<div class=\"wp-block-kadence-column kadence-column4207_9b3a2d-c2\"><div class=\"kt-inside-inner-col\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"220\" height=\"220\" src=\"https:\/\/spilerdug.dk\/wp-content\/uploads\/2016\/07\/ce_logo_220.jpg\" alt=\"\" class=\"wp-image-338\" title=\"\" srcset=\"https:\/\/spilerdug.dk\/wp-content\/uploads\/2016\/07\/ce_logo_220.jpg 220w, https:\/\/spilerdug.dk\/wp-content\/uploads\/2016\/07\/ce_logo_220-100x100.jpg 100w, https:\/\/spilerdug.dk\/wp-content\/uploads\/2016\/07\/ce_logo_220-150x150.jpg 150w\" sizes=\"auto, (max-width: 220px) 100vw, 220px\" \/><\/figure>\n<\/div>\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"88\" height=\"88\" src=\"https:\/\/spilerdug.dk\/wp-content\/uploads\/2020\/06\/gtin-stregkode.jpg\" alt=\"\" class=\"wp-image-4578\" style=\"width:98px;height:auto\" title=\"\"><\/figure>\n<\/div><\/div><\/div>\n\n\n<style>.kadence-column4207_04b0b6-d2 > .kt-inside-inner-col,.kadence-column4207_04b0b6-d2 > .kt-inside-inner-col:before{border-top-left-radius:0px;border-top-right-radius:0px;border-bottom-right-radius:0px;border-bottom-left-radius:0px;}.kadence-column4207_04b0b6-d2 > .kt-inside-inner-col{column-gap:var(--global-kb-gap-sm, 1rem);}.kadence-column4207_04b0b6-d2 > .kt-inside-inner-col{flex-direction:column;}.kadence-column4207_04b0b6-d2 > .kt-inside-inner-col > .aligncenter{width:100%;}.kadence-column4207_04b0b6-d2 > .kt-inside-inner-col:before{opacity:0.3;}.kadence-column4207_04b0b6-d2{position:relative;}@media all and (max-width: 1024px){.kadence-column4207_04b0b6-d2 > .kt-inside-inner-col{flex-direction:column;justify-content:center;}}@media all and (max-width: 767px){.kadence-column4207_04b0b6-d2 > .kt-inside-inner-col{flex-direction:column;justify-content:center;}}<\/style>\n<div class=\"wp-block-kadence-column kadence-column4207_04b0b6-d2\"><div class=\"kt-inside-inner-col\">\n<p>Alseat \u00e4r medicinskt utrustning klass 1 och CE-godk\u00e4nt enligt relevanta krav i<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>EN 12182:2012<\/li>\n\n\n\n<li>EN\/ISO 10993<\/li>\n\n\n\n<li>MDR EU No. 2017\/745<\/li>\n<\/ul>\n\n\n\n<p>I f\u00f6rbindelse med CE-m\u00e4rkning av Spilerdug har man utarbetat en \u00f6verensst\u00e4mmelserapport och f\u00f6rs\u00e4kran om \u00f6verensst\u00e4mmelse.<\/p>\n\n\n\n<p>En riskbed\u00f6mning har utarbetats och ligger till grund f\u00f6r den generella v\u00e4gledningen i anv\u00e4ndning av Alseat. Ut\u00f6ver det har vi som en del av v\u00e5r kliniska \u00f6vervakning och utv\u00e4rdering st\u00e4ndig uppf\u00f6ljning via den n\u00e4ra kontakten vi har med kunderna.<\/p>\n\n\n\n<p><strong>Det betyder f\u00f6r er, att Alseat \u00e4r:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Anm\u00e4ld till l\u00e4kemedelsmyndigheten<\/li>\n\n\n\n<li>Pr\u00f6vad i f\u00f6rh\u00e5llande till standarden \u201dTekniska hj\u00e4lpmedel till funktionshindrade \u2013 generella krav och testmetoder\u201d<\/li>\n\n\n\n<li>Bevakad via klinisk evaluering<\/li>\n\n\n\n<li>Riskbed\u00f6md<\/li>\n<\/ul>\n\n\n\n<p>N\u00e4r Alseat levereras medf\u00f6ljer dessutom en leverant\u00f6rsv\u00e4gledning med alla relevanta punkter.<\/p>\n\n\n\n<p><strong>M\u00e4rkning och sp\u00e5rning av Alseat<\/strong><\/p>\n\n\n\n<p>Den senaste f\u00f6rordningen f\u00f6r medicinska produkter (EU 2017\/745) st\u00e4ller ytterligare krav till m\u00e4rkning och sp\u00e5rbarhet av medicinska produkter. Hos Spilerdug ApS registrera vi v\u00e5ra varor enligt rekommenderad GTIN standard. P\u00e5 det s\u00e4ttet kan vi koppla den minsta leveransenheten med leveransadressen hos kunden genom en standardiserad streckkod, s\u00e5 att vi alltid kan sp\u00e5ra produkten tillbaka till den faktiska produktionen.<\/p>\n<\/div><\/div>\n\n<\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>Alseat er medicinsk udstyr kl. 1 og CE-godkendt iht. relevante krav i I forbindelse med CE-godkendelse af Alseat er der udarbejdet overensstemmelsesrapport og overensstemmelseserkl\u00e6ringer. Der er udarbejdet en risikovurdering som grundlag for den generelle vejledning i brugen af Alseat. Derudover f\u00f8lger vi l\u00f8bende op gennem vores t\u00e6tte kundekontakt som en et led i den kliniske&#8230;<\/p>","protected":false},"author":24,"featured_media":0,"parent":3599,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"_kad_post_classname":"","footnotes":""},"class_list":["post-4207","page","type-page","status-publish","hentry"],"acf":[],"taxonomy_info":[],"featured_image_src_large":false,"author_info":{"display_name":"Nanna Westby","author_link":"https:\/\/spilerdug.dk\/sv\/author\/nanna\/"},"comment_info":0,"_links":{"self":[{"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/pages\/4207","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/users\/24"}],"replies":[{"embeddable":true,"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/comments?post=4207"}],"version-history":[{"count":13,"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/pages\/4207\/revisions"}],"predecessor-version":[{"id":10941,"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/pages\/4207\/revisions\/10941"}],"up":[{"embeddable":true,"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/pages\/3599"}],"wp:attachment":[{"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/media?parent=4207"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}