{"id":9651,"date":"2020-08-07T13:41:03","date_gmt":"2020-08-07T05:41:03","guid":{"rendered":"http:\/\/faradalemedia.com\/?p=2410"},"modified":"2020-08-07T13:41:03","modified_gmt":"2020-08-07T05:41:03","slug":"pendaftaran-dan-pemasaran-termometer-inframerah-di-malaysia-perlu-mematuhi-standard-ditetapkan","status":"publish","type":"post","link":"https:\/\/www.rakansarawak.com\/v4\/2020\/08\/07\/pendaftaran-dan-pemasaran-termometer-inframerah-di-malaysia-perlu-mematuhi-standard-ditetapkan\/","title":{"rendered":"Pendaftaran dan Pemasaran Termometer Inframerah di Malaysia Perlu Mematuhi Standard Ditetapkan"},"content":{"rendered":"<p><a href=\"http:\/\/faradalemedia.com\/v2\/wp-content\/uploads\/2020\/08\/art-352-01.jpg\"><img decoding=\"async\" class=\"aligncenter size-large wp-image-2411\" src=\"http:\/\/faradalemedia.com\/v2\/wp-content\/uploads\/2020\/08\/art-352-01-640x641.jpg\" alt=\"art-352-01\" \/><\/a><em>Termometer Inframerah Tanpa Sentuh<\/em><\/p>\n<p style=\"text-align: justify;\">Dalam keadaan darurat seperti semasa pandemik Covid-19, pengimportan dan pembekalan termometer inframerah tanpa sentuh adalah dibenarkan melalui lalulan akses khas tertakluk kepada syarat-syarat tertentu dan untuk jangka masa yang terhad.<\/p>\n<p style=\"text-align: justify;\">Bagi pendaftaran dan pemasaran termometer inframerah di Malaysia, ia perlu mematuhi pelbagai standard untuk menunjukkan keselamatan dan prestasinya.<\/p>\n<p style=\"text-align: justify;\">Antara standard yang perlu dipatuhi adalah seperti berikut;<\/p>\n<ul style=\"text-align: justify;\">\n<li>ISO 13485: <em>Medical devices &#8211; Quality management systems &#8211; Requirements for regulatory purposes<\/em><\/li>\n<li>ISO 14971:<em> Medical devices &#8211; Application of risk management to medical devices<\/em><\/li>\n<li>IEC 60601-1-11: <em>Medical electrical equipment &#8211; Part 1-11: General requirements for basic safety<\/em> <em>and essential performance &#8211; Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment<\/em><\/li>\n<li>ISO 14155: <em>Clinical investigation of medical devices for human subjects &#8211; Good clinical practice<\/em><\/li>\n<li>IEC 62366-1: <em>Medical devices &#8211; Part 1: Application of usability engineering to medical devices<\/em><\/li>\n<li>IEC 62304: <em>Medical devices software &#8211; Software life cycle processes<\/em><\/li>\n<li>EN 1041: <em>Information supplied by the manufacturer of medical devices<\/em><\/li>\n<li>ISO 80601: <em>Medical electrical equipment. Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement<\/em><\/li>\n<\/ul>\n<p style=\"text-align: justify;\">Setakat ini, sebanyak 64 jenama termometer inframerah tanpa sentuh telah didaftarkan serta menerima kebenaran untuk diimport dan dibekalkan ke Malaysia.<\/p>\n<p style=\"text-align: justify;\">Melalui laluan akses khas, tujuh jenama termometer inframerah tanpa sentuh lain telah diberikan kebenaran untuk tujuan sama bagi memenuhi keperluan semasa wabak Covid-19.<\/p>\n<p style=\"text-align: justify;\">Sehubungan itu, Kementerian Kesihatan Malaysia (KKM) tidak menafikan bahawa terdapatnya termometer inframerah tanpa sentuh yang tidak berdaftar atau mendapat kebenaran akses dalam pasaran.<\/p>\n<p style=\"text-align: justify;\">Berkenaan perkara ini, KKM melalui Pihak Berkuasa Peranti Perubatan (PBPP) akan terus memantau situasi ini dan akan mengambil tindakan terhadap mana-mana perlanggaran undang-undang sebagaimana yang diperuntukkan di bawah Akta 737.<\/p>\n<p style=\"text-align: justify;\">\n<p><em>\u00a0<\/em><\/p>\n<div style='text-align:center' class='yasr-auto-insert-visitor'><!--Yasr Visitor Votes Shortcode--><div id='yasr_visitor_votes_d1465c9d14727' class='yasr-visitor-votes'><div class=\"yasr-custom-text-vv-before yasr-custom-text-vv-before-9651\">Click to rate this post!<\/div><div id='yasr-vv-second-row-container-d1465c9d14727'\r\n                                        class='yasr-vv-second-row-container'><div id='yasr-visitor-votes-rater-d1465c9d14727'\r\n                                      class='yasr-rater-stars-vv'\r\n                                      data-rater-postid='9651'\r\n                                      data-rating='0'\r\n                                      data-rater-starsize='16'\r\n                                      data-rater-readonly='true'\r\n                                      data-rater-nonce='0904ebcaba'\r\n                                      data-issingular='false'\r\n                                    ><\/div><div class=\"yasr-vv-stats-text-container\" id=\"yasr-vv-stats-text-container-d1465c9d14727\"><svg xmlns=\"https:\/\/www.w3.org\/2000\/svg\" width=\"20\" height=\"20\"\r\n                                   class=\"yasr-dashicons-visitor-stats\"\r\n                                   data-postid=\"9651\"\r\n                                   id=\"yasr-stats-dashicon-d1465c9d14727\">\r\n                                   <path d=\"M18 18v-16h-4v16h4zM12 18v-11h-4v11h4zM6 18v-8h-4v8h4z\"><\/path>\r\n                               <\/svg><span id=\"yasr-vv-text-container-d1465c9d14727\" class=\"yasr-vv-text-container\">[Total: <span id=\"yasr-vv-votes-number-container-d1465c9d14727\">0<\/span>  Average: <span id=\"yasr-vv-average-container-d1465c9d14727\">0<\/span>]<\/span><\/div><div id='yasr-vv-loader-d1465c9d14727' class='yasr-vv-container-loader'><\/div><\/div><div id='yasr-vv-bottom-container-d1465c9d14727' class='yasr-vv-bottom-container'><div class='yasr-small-block-bold'><span class='yasr-visitor-votes-must-sign-in'>You must sign in to vote<\/span><\/div><\/div><\/div><!--End Yasr Visitor Votes Shortcode--><\/div>","protected":false},"excerpt":{"rendered":"<p>Termometer Inframerah Tanpa Sentuh Dalam keadaan darurat seperti semasa pandemik Covid-19, pengimportan dan pembekalan termometer inframerah tanpa sentuh adalah dibenarkan melalui lalulan akses khas tertakluk kepada syarat-syarat tertentu dan untuk jangka masa yang terhad. Bagi pendaftaran dan pemasaran termometer inframerah di Malaysia, ia perlu mematuhi pelbagai standard untuk menunjukkan keselamatan dan prestasinya. Antara standard yang [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"yasr_overall_rating":0,"yasr_post_is_review":"","yasr_auto_insert_disabled":"","yasr_review_type":"","footnotes":""},"categories":[2582],"tags":[],"class_list":{"0":"post-9651","1":"post","2":"type-post","3":"status-publish","4":"format-standard","6":"category-news-and-events"},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.3 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Pendaftaran dan Pemasaran Termometer Inframerah di Malaysia Perlu Mematuhi Standard Ditetapkan - RAKAN Sarawak<\/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.rakansarawak.com\/v4\/2020\/08\/07\/pendaftaran-dan-pemasaran-termometer-inframerah-di-malaysia-perlu-mematuhi-standard-ditetapkan\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pendaftaran dan Pemasaran Termometer Inframerah di Malaysia Perlu Mematuhi Standard Ditetapkan - RAKAN Sarawak\" \/>\n<meta property=\"og:description\" content=\"Termometer Inframerah Tanpa Sentuh Dalam keadaan darurat seperti semasa pandemik Covid-19, pengimportan dan pembekalan termometer inframerah tanpa sentuh adalah dibenarkan melalui lalulan akses khas tertakluk kepada syarat-syarat tertentu dan untuk jangka masa yang terhad. 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