{"id":1205,"date":"2025-09-24T08:19:43","date_gmt":"2025-09-24T01:19:43","guid":{"rendered":"https:\/\/stp.poltekkes-smg.ac.id\/?p=1205"},"modified":"2025-10-06T14:19:04","modified_gmt":"2025-10-06T07:19:04","slug":"pelatihan-iso-111352014","status":"publish","type":"post","link":"https:\/\/stp.poltekkes-smg.ac.id\/index.php\/pelatihan-iso-111352014\/","title":{"rendered":"Pelatihan ISO 11135:2014 terkait optimalisasi layanan Science Techno Park (STP) Poltekkes Kemenkes RI di\u00a0Kab.\u00a0Pekalongan"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">ISO 11135:2014 adalah standar internasional yang menetapkan persyaratan untuk pengembangan, validasi, dan kontrol rutin proses sterilisasi alat kesehatan dengan menggunakan gas etilena oksida (EtO). Standar ini menekankan pentingnya proses yang tervalidasi agar produk alat kesehatan benar-benar bebas dari mikroorganisme hingga mencapai tingkat jaminan sterilitas tertentu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Definisi ISO 11135:2014<br>ISO 11135:2014 mengatur seluruh tahapan penting sterilisasi, mulai dari persiapan (pra-kondisi), pelaksanaan sterilisasi, validasi proses, hingga pengendalian hasil secara rutin. Standar ini bersifat wajib khususnya untuk produsen alat kesehatan yang menggunakan sterilisasi EtO sebagai teknik utama untuk memastikan keamanan produk sebelum digunakan.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Manfaat untuk Science Techno Park<br>Penerapan ISO 11135:2014 di Science Techno Park (STP) memiliki beberapa manfaat strategis:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Mendukung proses inkubasi dan hilirisasi produk riset berupa alat kesehatan yang harus melalui tahap validasi sterilisasi sebelum diproduksi massal dan dipasarkan.<\/li>\n\n\n\n<li>Meningkatkan kredibilitas dan daya saing produk inovasi Poltekkes di pasar nasional maupun global dengan mematuhi standar mutu internasional.<\/li>\n\n\n\n<li>Memudahkan kolaborasi dengan industri alat kesehatan, karena kebutuhan pemenuhan standar ISO menjadi prasyarat kemitraan produksi atau ekspor.<\/li>\n\n\n\n<li>Menjamin keamanan dan efektivitas alat\/media riset yang digunakan atau dikembangkan di lingkungan STP sehingga meminimalkan risiko kontaminasi dan meningkatkan keberhasilan transfer teknologi dari riset ke produk siap pasar.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Implikasi Praktis di STP Poltekkes Kemenkes<br>Implementasi standar ini di STP dapat dilakukan dengan menyediakan fasilitas laboratorium sterilisasi berstandar ISO 11135:2014 untuk para peneliti, startup, dan mitra industri. Dengan begitu, proses pengujian dan validasi alat kesehatan bisa langsung dilakukan di lingkungan Poltekkes, mempercepat time-to-market inovasi dan memperkuat posisi universitas sebagai pusat transfer teknologi dan industri alat kesehatan.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>ISO 11135:2014 adalah standar internasional yang menetapkan persyaratan untuk pengembangan, validasi, dan kontrol rutin proses sterilisasi alat kesehatan dengan menggunakan [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1206,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[1],"tags":[],"class_list":["post-1205","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tak-berkategori"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - 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