{"id":4214,"date":"2020-05-14T13:48:04","date_gmt":"2020-05-14T11:48:04","guid":{"rendered":"https:\/\/spilerdug.dk.web05.webtohosting.dk\/?page_id=4214"},"modified":"2024-10-10T11:31:26","modified_gmt":"2024-10-10T09:31:26","slug":"certificering-af-spiler","status":"publish","type":"page","link":"https:\/\/spilerdug.dk\/sv\/om-os\/certificering-og-maerkning\/certificering-af-spiler\/","title":{"rendered":"Certifiering av Spiler+"},"content":{"rendered":"<style>.kb-row-layout-id4214_ff7f2f-1e > .kt-row-column-wrap{align-content:start;}:where(.kb-row-layout-id4214_ff7f2f-1e > .kt-row-column-wrap) > .wp-block-kadence-column{justify-content:start;}.kb-row-layout-id4214_ff7f2f-1e > .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-id4214_ff7f2f-1e > .kt-row-layout-overlay{opacity:0.30;}@media all and (max-width: 1024px){.kb-row-layout-id4214_ff7f2f-1e > .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-id4214_ff7f2f-1e > .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-id4214_ff7f2f-1e 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 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kb-section-dir-vertical\"><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<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:143px;height:auto\" title=\"\"><\/figure>\n<\/div>\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=\"710\" height=\"550\" src=\"https:\/\/spilerdug.dk\/wp-content\/uploads\/2024\/09\/oekotex.jpg\" alt=\"\" class=\"wp-image-11487\" style=\"width:325px;height:auto\" 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-column4214_13fe2b-bc > .kt-inside-inner-col,.kadence-column4214_13fe2b-bc > .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-column4214_13fe2b-bc > .kt-inside-inner-col{column-gap:var(--global-kb-gap-sm, 1rem);}.kadence-column4214_13fe2b-bc > .kt-inside-inner-col{flex-direction:column;}.kadence-column4214_13fe2b-bc > .kt-inside-inner-col > .aligncenter{width:100%;}.kadence-column4214_13fe2b-bc > .kt-inside-inner-col:before{opacity:0.3;}.kadence-column4214_13fe2b-bc{position:relative;}@media all and (max-width: 1024px){.kadence-column4214_13fe2b-bc > .kt-inside-inner-col{flex-direction:column;justify-content:center;}}@media all and (max-width: 767px){.kadence-column4214_13fe2b-bc > .kt-inside-inner-col{flex-direction:column;justify-content:center;}}<\/style>\n<div class=\"wp-block-kadence-column kadence-column4214_13fe2b-bc\"><div class=\"kt-inside-inner-col\">\n<p>V\u00e5r Spiler+ v\u00e4ndsystem \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 Spiler+ v\u00e4ndsystem 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 Spiler+ v\u00e4ndsystem. 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 v\u00e5rt Spiler+ v\u00e4ndsystem<\/strong><strong>:<\/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 Spiler+ v\u00e4ndsystem 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 Spiler+ v\u00e4ndsystem<\/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\n\n\n<p>V\u00e5r Spiler+ v\u00e4ndsystem \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>Det betyder att Spiler+ \u00e4r testat f\u00f6r mer \u00e4n 300 skadliga \u00e4mnen, vilket ligger l\u00e5ngt \u00f6ver lagstiftningen i EU, och s\u00e4kerst\u00e4ller mot skadlig kemi i produktionen.<\/p>\n<\/div><\/div>\n\n<\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>Vores Spiler+ vendesystem 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 Spiler+ vendesystem er der udarbejdet overensstemmelsesrapport og overensstemmelseserkl\u00e6ringer. Der er udarbejdet en risikovurdering som grundlag for den generelle vejledning i brugen af&#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-4214","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\/4214","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=4214"}],"version-history":[{"count":20,"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/pages\/4214\/revisions"}],"predecessor-version":[{"id":11538,"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/pages\/4214\/revisions\/11538"}],"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=4214"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}