{"id":36744,"date":"2026-10-24T09:25:53","date_gmt":"2026-10-24T08:25:53","guid":{"rendered":"https:\/\/www.certifiedcosmetics.com\/blog\/okategoriserad\/vad-ar-stabilitetstestning-enligt-iso-18811\/"},"modified":"2026-10-24T09:25:53","modified_gmt":"2026-10-24T08:25:53","slug":"vad-ar-stabilitetstestning-enligt-iso-18811","status":"publish","type":"post","link":"https:\/\/www.certifiedcosmetics.com\/sv\/blog\/laboratorieundersokningar\/vad-ar-stabilitetstestning-enligt-iso-18811\/","title":{"rendered":"Vad \u00e4r stabilitetstestning enligt ISO 18811?"},"content":{"rendered":"

\"\"N\u00e4r man talar om stabilitetstester f\u00f6r kosmetiska produkter dyker en referens ofta upp i teknisk dokumentation och laboratorieprotokoll: ISO\/TR 18811:2018<\/strong>. Tillverkare antar ofta att det r\u00f6r sig om en obligatorisk teststandard eller att den f\u00f6reskriver ett specifikt laboratorief\u00f6rfarande. I sj\u00e4lva verket st\u00e4mmer inget av detta.<\/p>\n

ISO\/TR 18811 \u00e4r en teknisk rapport<\/strong> som ger vetenskapliga riktlinjer f\u00f6r hur stabilitetsprovning av kosmetiska produkter b\u00f6r genomf\u00f6ras. Ist\u00e4llet f\u00f6r att fastst\u00e4lla obligatoriska provningsvillkor eller godk\u00e4nnandekriterier erbjuder den ett ramverk som hj\u00e4lper tillverkare att utforma l\u00e4mpliga stabilitetsstudier utifr\u00e5n varje produkts egenskaper.<\/p>\n

Genom att f\u00f6rst\u00e5 vilken roll ISO\/TR 18811 spelar kan kosmetikf\u00f6retag tolka laboratorierapporter p\u00e5 r\u00e4tt s\u00e4tt och utforma testprogram som b\u00e5de \u00e4r vetenskapligt v\u00e4lgrundade och \u00f6verensst\u00e4mmer med de europeiska lagstiftningskraven.<\/p>\n

Vad \u00e4r ISO\/TR 18811?<\/h2>\n

ISO\/TR 18811:2018<\/strong>, Kosmetika \u2013 Riktlinjer f\u00f6r stabilitetsprovning av kosmetiska produkter<\/em>, publicerades av Internationella standardiseringsorganisationen (ISO) f\u00f6r att ge v\u00e4gledning om stabilitetsbed\u00f6mning av kosmetiska produkter.<\/p>\n

Det \u00e4r viktigt att notera att detta dokument \u00e4r en teknisk rapport (TR)<\/strong> och inte en internationell standard. Denna skillnad \u00e4r av betydelse. Till skillnad fr\u00e5n en standard som anger obligatoriska krav eller detaljerade testmetoder inneh\u00e5ller en teknisk rapport rekommendationer, bakgrundsinformation och god vetenskaplig praxis. Den hj\u00e4lper tillverkare att f\u00f6rst\u00e5 hur stabilitetstester kan planeras, men \u00f6verl\u00e5ter den slutgiltiga teststrategin till det f\u00f6retag som ansvarar f\u00f6r att sl\u00e4ppa ut produkten p\u00e5 marknaden.<\/p>\n

\u00c4r ISO\/TR 18811 obligatorisk inom Europeiska unionen?<\/h2>\n

Nej. Varken f\u00f6rordning (EG) nr 1223\/2009<\/strong> eller n\u00e5gon officiell europeisk v\u00e4gledning kr\u00e4ver att tillverkare specifikt ska f\u00f6lja ISO\/TR 18811.<\/p>\n

F\u00f6rordningen kr\u00e4ver dock att kosmetiska produkter \u00e4r s\u00e4kra under normala eller rimligt f\u00f6rutsebara anv\u00e4ndningsf\u00f6rh\u00e5llanden. Att p\u00e5visa produktens stabilitet utg\u00f6r en del av den vetenskapliga dokumentationen som ligger till grund f\u00f6r s\u00e4kerhetsbed\u00f6mningen.<\/p>\n

Eftersom ISO\/TR 18811 \u00e5terspeglar internationellt erk\u00e4nda vetenskapliga principer anv\u00e4nder m\u00e5nga laboratorier och experter inom tillsynsmyndigheterna den som referens n\u00e4r de utformar stabilitetsstudier och dokumenterar sina motiveringar.<\/p>\n

Vad s\u00e4ger egentligen ISO\/TR 18811?<\/h2>\n

Ett av de viktigaste budskapen i ISO\/TR 18811 \u00e4r att det inte finns n\u00e5got universellt protokoll f\u00f6r stabilitetsprovning som passar alla kosmetiska produkter<\/strong>.<\/p>\n

I rapporten erk\u00e4nns den enorma m\u00e5ngfalden av kosmetiska formuleringar, f\u00f6rpackningssystem, f\u00f6rvaringsf\u00f6rh\u00e5llanden och avsedda anv\u00e4ndningsomr\u00e5den. Mot denna bakgrund drar rapporten slutsatsen att tillverkarna b\u00f6r utarbeta och motivera sina egna stabilitetsprotokoll utifr\u00e5n vetenskapliga \u00f6verv\u00e4ganden, snarare \u00e4n att f\u00f6lja ett enda f\u00f6rutbest\u00e4mt f\u00f6rfarande.<\/p>\n

Denna flexibla strategi ligger i linje med den europeiska kosmetiklagstiftningen, som l\u00e4gger ansvaret p\u00e5 tillverkaren att ta fram l\u00e4mpliga bevis f\u00f6r varje enskild produkt.<\/p>\n

I ISO\/TR 18811 behandlas de viktigaste aspekterna som b\u00f6r beaktas vid planeringen av ett stabilitetsprogram. Bland de \u00e4mnen som tas upp finns:<\/p>\n

    \n
  • De vetenskapliga principerna bakom kosmetiska produkters stabilitet<\/li>\n
  • Faktorer som kan p\u00e5verka produktens stabilitet<\/li>\n
  • Val av l\u00e4mpliga testmetoder<\/li>\n
  • F\u00f6rvaringsf\u00f6rh\u00e5llanden och studiens utformning<\/li>\n
  • Utv\u00e4rdering av stabilitetsresultat<\/li>\n
  • Dokumentation av slutsatser<\/li>\n<\/ul>\n

    Rapporten ger dessutom en \u00f6versikt \u00f6ver befintlig vetenskaplig litteratur och tidigare publicerade riktlinjer, vilket ger tillverkarna en anv\u00e4ndbar ram f\u00f6r att v\u00e4lja l\u00e4mpliga teststrategier.<\/p>\n

    Hur b\u00f6r tillverkare anv\u00e4nda ISO\/TR 18811?<\/h2>\n

    F\u00f6r de flesta kosmetikf\u00f6retag b\u00f6r ISO\/TR 18811 ses som ett referensdokument snarare \u00e4n en checklista f\u00f6r efterlevnad.<\/p>\n

    Det hj\u00e4lper tillverkare att f\u00f6rst\u00e5 varf\u00f6r stabilitetsprovningsprogrammen skiljer sig \u00e5t mellan olika produkter och varf\u00f6r laboratorier kan rekommendera olika unders\u00f6kningsuppl\u00e4gg beroende p\u00e5 vilken formulering som utv\u00e4rderas.<\/p>\n

    I st\u00e4llet f\u00f6r att fr\u00e5ga om en produkt \u00e4r \u201dtestad enligt ISO\/TR 18811\u201d \u00e4r det oftast l\u00e4mpligare att fr\u00e5ga om stabilitetsprogrammet har utformats utifr\u00e5n vetenskapligt underbyggda principer som \u00f6verensst\u00e4mmer med rekommendationerna i standarden.<\/p>\n","protected":false},"excerpt":{"rendered":"

    N\u00e4r man talar om stabilitetstester f\u00f6r kosmetiska produkter dyker en referens ofta upp i teknisk dokumentation och laboratorieprotokoll: ISO\/TR 18811:2018. Tillverkare antar ofta att det r\u00f6r sig om en obligatorisk teststandard eller att den f\u00f6reskriver ett specifikt laboratorief\u00f6rfarande. I sj\u00e4lva verket st\u00e4mmer inget av detta. ISO\/TR 18811 \u00e4r en teknisk rapport som ger vetenskapliga riktlinjer…<\/p>\n","protected":false},"author":294,"featured_media":36745,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4164],"tags":[],"class_list":["post-36744","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-laboratorieundersokningar"],"yoast_head":"\nVad \u00e4r stabilitetstestning enligt ISO 18811? - Certified Cosmetics<\/title>\n<meta name=\"description\" content=\"L\u00e4r dig vad ISO\/TR 18811 \u00e4r, hur standarden fungerar som riktlinje f\u00f6r stabilitetsprovning av kosmetiska produkter och varf\u00f6r den anv\u00e4nds i stor utstr\u00e4ckning f\u00f6r att fastst\u00e4lla h\u00e5llbarhetstid och s\u00e4kerst\u00e4lla efterlevnad av EU:s regelverk.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.certifiedcosmetics.com\/sv\/blog\/laboratorieundersokningar\/vad-ar-stabilitetstestning-enligt-iso-18811\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Vad \u00e4r stabilitetstestning enligt ISO 18811?\" \/>\n<meta property=\"og:description\" content=\"L\u00e4r dig vad ISO\/TR 18811 \u00e4r, hur standarden fungerar som riktlinje f\u00f6r stabilitetsprovning av kosmetiska produkter och varf\u00f6r den anv\u00e4nds i stor utstr\u00e4ckning f\u00f6r att fastst\u00e4lla h\u00e5llbarhetstid och s\u00e4kerst\u00e4lla efterlevnad av EU:s regelverk.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.certifiedcosmetics.com\/sv\/blog\/laboratorieundersokningar\/vad-ar-stabilitetstestning-enligt-iso-18811\/\" \/>\n<meta property=\"og:site_name\" content=\"Certified Cosmetics\" \/>\n<meta property=\"article:published_time\" content=\"2026-10-24T08:25:53+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.certifiedcosmetics.com\/wp-content\/uploads\/2026\/07\/isotr-18811.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"800\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Angela\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Skriven av\" \/>\n\t<meta name=\"twitter:data1\" content=\"Angela\" \/>\n\t<meta name=\"twitter:label2\" content=\"Ber\u00e4knad l\u00e4stid\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minuter\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.certifiedcosmetics.com\\\/sv\\\/blog\\\/laboratorieundersokningar\\\/vad-ar-stabilitetstestning-enligt-iso-18811\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.certifiedcosmetics.com\\\/sv\\\/blog\\\/laboratorieundersokningar\\\/vad-ar-stabilitetstestning-enligt-iso-18811\\\/\"},\"author\":{\"name\":\"Angela\",\"@id\":\"https:\\\/\\\/www.certifiedcosmetics.com\\\/sv\\\/#\\\/schema\\\/person\\\/2620f9d56cb0c867784edb68de06746c\"},\"headline\":\"Vad \u00e4r stabilitetstestning enligt ISO 18811?\",\"datePublished\":\"2026-10-24T08:25:53+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.certifiedcosmetics.com\\\/sv\\\/blog\\\/laboratorieundersokningar\\\/vad-ar-stabilitetstestning-enligt-iso-18811\\\/\"},\"wordCount\":656,\"publisher\":{\"@id\":\"https:\\\/\\\/www.certifiedcosmetics.com\\\/sv\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/www.certifiedcosmetics.com\\\/sv\\\/blog\\\/laboratorieundersokningar\\\/vad-ar-stabilitetstestning-enligt-iso-18811\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.certifiedcosmetics.com\\\/wp-content\\\/uploads\\\/2026\\\/07\\\/isotr-18811.jpg\",\"articleSection\":[\"Laboratorieunders\u00f6kningar\"],\"inLanguage\":\"sv-SE\",\"copyrightYear\":\"2026\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/www.certifiedcosmetics.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.certifiedcosmetics.com\\\/sv\\\/blog\\\/laboratorieundersokningar\\\/vad-ar-stabilitetstestning-enligt-iso-18811\\\/\",\"url\":\"https:\\\/\\\/www.certifiedcosmetics.com\\\/sv\\\/blog\\\/laboratorieundersokningar\\\/vad-ar-stabilitetstestning-enligt-iso-18811\\\/\",\"name\":\"Vad \u00e4r stabilitetstestning enligt ISO 18811? 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