{"id":4194,"date":"2020-05-14T13:17:16","date_gmt":"2020-05-14T11:17:16","guid":{"rendered":"https:\/\/spilerdug.dk.web05.webtohosting.dk\/?page_id=4194"},"modified":"2026-03-03T09:01:09","modified_gmt":"2026-03-03T08:01:09","slug":"certificering-av-spilerdug","status":"publish","type":"page","link":"https:\/\/spilerdug.dk\/sv\/om-os\/certificering-og-maerkning\/certificering-af-spilerdug\/","title":{"rendered":"Certificering av Spilerdug"},"content":{"rendered":"<style>.kb-row-layout-id4194_fb6a0e-80 > .kt-row-column-wrap{align-content:start;}:where(.kb-row-layout-id4194_fb6a0e-80 > .kt-row-column-wrap) > .wp-block-kadence-column{justify-content:start;}.kb-row-layout-id4194_fb6a0e-80 > .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-id4194_fb6a0e-80 > .kt-row-layout-overlay{opacity:0.30;}@media all and (max-width: 1024px){.kb-row-layout-id4194_fb6a0e-80 > .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-id4194_fb6a0e-80 > .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-id4194_fb6a0e-80 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-column4194_0f756e-4b > .kt-inside-inner-col,.kadence-column4194_0f756e-4b > .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-column4194_0f756e-4b > .kt-inside-inner-col{column-gap:var(--global-kb-gap-sm, 1rem);}.kadence-column4194_0f756e-4b > .kt-inside-inner-col{flex-direction:column;}.kadence-column4194_0f756e-4b > .kt-inside-inner-col > .aligncenter{width:100%;}.kadence-column4194_0f756e-4b > .kt-inside-inner-col:before{opacity:0.3;}.kadence-column4194_0f756e-4b{position:relative;}@media all and (max-width: 1024px){.kadence-column4194_0f756e-4b > .kt-inside-inner-col{flex-direction:column;justify-content:center;}}@media all and (max-width: 767px){.kadence-column4194_0f756e-4b > .kt-inside-inner-col{flex-direction:column;justify-content:center;}}<\/style>\n<div class=\"wp-block-kadence-column kadence-column4194_0f756e-4b\"><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<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:148px;height:auto\" title=\"\"><\/figure>\n<\/div>\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"710\" height=\"550\" src=\"https:\/\/spilerdug.dk\/wp-content\/uploads\/2024\/09\/oekotex.jpg\" alt=\"\" class=\"wp-image-11487\" title=\"\" srcset=\"https:\/\/spilerdug.dk\/wp-content\/uploads\/2024\/09\/oekotex.jpg 710w, https:\/\/spilerdug.dk\/wp-content\/uploads\/2024\/09\/oekotex-300x232.jpg 300w, https:\/\/spilerdug.dk\/wp-content\/uploads\/2024\/09\/oekotex-600x465.jpg 600w\" sizes=\"auto, (max-width: 710px) 100vw, 710px\" \/><\/figure>\n<\/div><\/div><\/div>\n\n\n<style>.kadence-column4194_569fcc-2a > .kt-inside-inner-col,.kadence-column4194_569fcc-2a > .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-column4194_569fcc-2a > .kt-inside-inner-col{column-gap:var(--global-kb-gap-sm, 1rem);}.kadence-column4194_569fcc-2a > .kt-inside-inner-col{flex-direction:column;}.kadence-column4194_569fcc-2a > .kt-inside-inner-col > .aligncenter{width:100%;}.kadence-column4194_569fcc-2a > .kt-inside-inner-col:before{opacity:0.3;}.kadence-column4194_569fcc-2a{position:relative;}@media all and (max-width: 1024px){.kadence-column4194_569fcc-2a > .kt-inside-inner-col{flex-direction:column;justify-content:center;}}@media all and (max-width: 767px){.kadence-column4194_569fcc-2a > .kt-inside-inner-col{flex-direction:column;justify-content:center;}}<\/style>\n<div class=\"wp-block-kadence-column kadence-column4194_569fcc-2a\"><div class=\"kt-inside-inner-col\">\n<p>V\u00e5r Spilerdug \u00e4r CE-m\u00e4rkt i enlighet med Europaparlamentets och r\u00e5dets f\u00f6rordning (EU) MDR 2017\/745 av den 5 april 2017 om medicintekniska produkter och uppfyller standarden DS\/EN ISO 21856:2022.<\/p>\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 Spilerdug. 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 att v\u00e5r Spilerdug \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>Dessutom medf\u00f6ljer en <strong><a href=\"https:\/\/spilerdug.dk\/wp-content\/uploads\/2025\/06\/Generell-vagledning-vid-anvandning-av-Spilerdug-2025.pdf\" data-type=\"link\" data-id=\"https:\/\/spilerdug.dk\/wp-content\/uploads\/2025\/06\/Generell-vagledning-vid-anvandning-av-Spilerdug-2025.pdf\">Generell v\u00e4gledning vid anv\u00e4ndning av Spilerdug<\/a><\/strong>, n\u00e4r du mottager Spilerdug, d\u00e4r alla relevanta punkter finns med.<\/p>\n\n\n\n<p><strong>M\u00e4rkning och sp\u00e5rning av Spilerdug<\/strong><\/p>\n\n\n\n<p>Den senaste f\u00f6rordningen f\u00f6r medicinska produkter (MDR 2017\/745) st\u00e4ller ytterligare krav p\u00e5 m\u00e4rkning och sp\u00e5rbarhet av medicinska produkter. Hos Spilerdug ApS registrerar vi v\u00e5ra varor enligt den rekommenderade GTIN-standarden. P\u00e5 s\u00e5 s\u00e4tt kan vi koppla den minsta leveransenheten till leveransplatsen hos kunden genom en standardiserad streckkod, s\u00e5 att vi alltid kan sp\u00e5ra produkten tillbaka till den specifika produktionen.<\/p>\n\n\n\n<p><strong>OEKO-TEX 100 Certificeret<\/strong><\/p>\n\n\n\n<p>V\u00e5r Spilerdug \u00e4r dessutom verifierad efter Oekotex 100 standarden, som \u00e4r v\u00e4rldens f\u00f6rande m\u00e4rkning f\u00f6r textilier och textilliknande produkter (ocks\u00e5 halvfabrikat) som \u00e4r unders\u00f6kt f\u00f6r h\u00e4lso- och milj\u00f6skadliga \u00e4mnen.<\/p>\n\n\n\n<p class=\"translation-block\">Det betyder, att Spilerdugen \u00e4r testad f\u00f6r mer \u00e4n 300 skadliga \u00e4mnen, vilket l\u00e5ngt \u00f6verg\u00e5r lagstiftningen i EU, og skyddar mot skadliga kemikalier i produktionen. Du kan se <a href=\"https:\/\/spilerdug.dk\/wp-content\/uploads\/2024\/09\/Brehms-Spilerdug_2276-369-03_DTI-1.pdf\" data-type=\"link\" data-id=\"https:\/\/spilerdug.dk\/wp-content\/uploads\/2024\/09\/Brehms-Spilerdug_2276-369-03_DTI-1.pdf\" target=\"_self\">certifikatet h\u00e4r<\/a>.<\/p>\n<\/div><\/div>\n\n<\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>Vores Spilerdug er CE-m\u00e6rket i overensstemmelse med Europa-Parlamentets og R\u00e5dets forordning (EU) MDR 2017\/745 af 5. april 2017 om medicinsk udstyr og efterlever&nbsp; standarden DS\/EN ISO 21856:2022. I forbindelse med CE-m\u00e6rkning af spilerdug er der udarbejdet overensstemmelsesrapport og overensstemmelseserkl\u00e6ringer. Der er udarbejdet en risikovurdering som grundlag for den generelle vejledning i brugen af Spilerdug. Derudover&#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-4194","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\/4194","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=4194"}],"version-history":[{"count":35,"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/pages\/4194\/revisions"}],"predecessor-version":[{"id":12766,"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/pages\/4194\/revisions\/12766"}],"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=4194"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}