mesin membuat perubatan china<\/strong><\/a>\u00a0hendaklah dinyatakan, dan laporan pengesahan pensterilan hendaklah disediakan. Untuk produk yang akan disterilkan oleh pengguna akhir, proses pensterilan yang disyorkan (kaedah dan parameter) dan asas untuk kaedah pensterilan yang disyorkan hendaklah ditentukan. Jika etilena oksida digunakan untuk pensterilan, keperluan untuk sisa dan kaedah rawatan yang diterima pakai hendaklah dijelaskan, dan data penyelidikan hendaklah disediakan.<\/p>\n(Tiga) tarikh luput produk<\/p>\n
Asas untuk menentukan kesahihan sarung tangan perubatan dan data pengesahan yang berkaitan hendaklah disediakan. Rujuk EN 455-4-2009 \u201cKeperluan dan Ujian untuk Penentuan Jangka Hayat Sarung Tangan Perubatan Pakai\u201d. Dan data penyelidikan untuk mengekalkan integriti pakej semasa tempoh sah yang dinyatakan dan keadaan pengangkutan dan penyimpanan.<\/p>\n
05. Arahan produk dan keperluan pelabelan<\/p>\n
Penerangan dan label produk hendaklah mematuhi "Arahan Peranti Perubatan dan Peraturan Pengurusan Label" (Perintah Pentadbiran Makanan dan Ubat Negeri No. 6), "Simbol untuk pelabelan, penandaan dan penyediaan maklumat peranti perubatan untuk peranti perubatan. Bahagian 1: Keperluan am" (YY \/ T 0466.1-2009) dan piawaian yang berkaitan.<\/p>\n
(1) Pembungkusan dalam hendaklah ditanda dengan jelas:<\/p>\n
(1) saiz;<\/p>\n
(2) \u201cKiri\u201d atau \u201cKanan\u201d hendaklah ditanda pada pembungkusan dalam;<\/p>\n
(3) Sarung tangan serbuk harus mempunyai "Nota: Operasi aseptik harus digunakan untuk mengeluarkan serbuk permukaan sebelum pembedahan untuk meminimumkan risiko tindak balas tisu yang buruk." Atau "Setelah sarung tangan telah dirawat dengan apa-apa bahan serbuk permukaan, perlu ada amaran Serbuk permukaan hendaklah dikeluarkan secara aseptik sebelum pembedahan. "Atau yang setara;<\/p>\n
(4) Sarung tangan yang diperbuat daripada lateks getah asli hendaklah mempunyai "(produk) mengandungi lateks getah asli yang boleh menyebabkan tindak balas alahan" atau arahan yang setara;<\/p>\n
(5) Jika produk diisytiharkan mengandungi protein, had proses yang ditentukan hendaklah diberikan;<\/p>\n
(6) \u201cHypoallergenicity\u201d tidak boleh ditanda.<\/p>\n
(2) Pembungkusan unit secara amnya termasuk yang berikut:<\/p>\n
(1) nama atau tanda dagangan pengilang atau pembekal;<\/p>\n
(2) Bahan yang digunakan;<\/p>\n
(3) \u201cJari lurus\u201d atau \u201cjari melengkung\u201d, atau perkataan serupa yang menunjukkan kandungan reka bentuk sarung tangan;<\/p>\n
(4) perkataan "permukaan hem" atau "permukaan berkilat", "dengan serbuk" atau "tiada serbuk", atau kesan serupa pada jenis sarung tangan;<\/p>\n
(5) saiz;<\/p>\n
(6) Nombor kelompok pengeluaran, tarikh pengeluaran, tempoh penggunaan atau tarikh luput;<\/p>\n
(7) Nyatakan status produk: \u201cdisterilkan melainkan bungkusan dibuka atau rosak\u201d atau \u201ctidak steril\u201d;<\/p>\n
(8) "Penggunaan sekali sahaja";<\/p>\n
(9) perkataan \u201csarung tangan pembedahan\u201d atau \u201csarung tangan pemeriksaan\u201d;<\/p>\n
(10) Bagi sarung tangan kategori 1, perkataan "Produk diperbuat daripada lateks getah asli yang boleh menyebabkan tindak balas alahan" ditandakan.<\/p>\n
(11) Semasa penyimpanan produk, jangan sentuh minyak, asid, alkali, kuprum, mangan atau pelarut organik lain. Elakkan cahaya matahari atau cahaya buatan yang mengandungi sinaran ultraungu. Gudang hendaklah bebas daripada peranti penjana ozon dan dijauhkan daripada bahan radioaktif.<\/p>\n
(Tiga) pembungkusan berbilang unit<\/p>\n
Pembungkusan berbilang unit ialah kotak produk dengan bilangan unit sarung tangan yang telah ditetapkan dengan saiz yang sama. Tujuannya adalah untuk memudahkan pengangkutan dan penyimpanan yang selamat. Pakej berbilang unit dilabelkan sebagai pakej tunggal, dan bilangan sarung tangan serta arahan penyimpanan tambahan hendaklah ditunjukkan.<\/p>","protected":false},"excerpt":{"rendered":"
04, Keperluan proses pengeluaran (I) Keperluan berkaitan untuk pembuatan produk Proses pengeluaran produk sarung tangan perubatan hendaklah dinyatakan. Proses utama dan proses khas hendaklah dicatatkan dalam carta alir proses, dan titik kawalan prosesnya hendaklah dijelaskan. Jelaskan penggunaan pelbagai alat bantu pemprosesan dan [\u2026]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"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":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"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":""},"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-17262","post","type-post","status-publish","format-standard","hentry","category-blog"],"acf":[],"yoast_head":"\n
Classification, Production and Testing Requirements of Medical Gloves (Part 2) - Fengwang<\/title>\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.gloveequipment.com\/ms\/peristiwa-berita\/production-and-testing-requirements%20.html\" \/>\n<meta property=\"og:locale\" content=\"ms_MY\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Classification, Production and Testing Requirements of Medical Gloves (Part 2) - Fengwang\" \/>\n<meta property=\"og:description\" content=\"04, Production process requirements (I) Relevant requirements for product manufacturing The production process of medical glove products should be specified. Key processes and special processes should be noted in the process flow chart, and their process control points should be explained. 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<\/p>\n