{"id":1418,"date":"2021-09-23T15:26:29","date_gmt":"2021-09-23T07:26:29","guid":{"rendered":"https:\/\/bmp.icpdas.com\/?page_id=1418"},"modified":"2022-02-22T10:22:06","modified_gmt":"2022-02-22T02:22:06","slug":"medical-application-policy","status":"publish","type":"page","link":"https:\/\/bmp.icpdas.com\/wordpress\/medical-application-policy\/","title":{"rendered":"Medical Application Policy"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1418\" class=\"elementor elementor-1418\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a28b894 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a28b894\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3fbbbb7\" data-id=\"3fbbbb7\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3dc7e4a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3dc7e4a\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b3dd479\" data-id=\"b3dd479\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1127613 elementor-widget elementor-widget-heading\" data-id=\"1127613\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-large\"><b>Medical Application Policy<\/b><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-caa88c5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"caa88c5\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-57c92b5\" data-id=\"57c92b5\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-dc32ac8 elementor-widget elementor-widget-text-editor\" data-id=\"dc32ac8\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"color: #000000;\">ICP DAS is a dedicated ISO13485:2016 certified manufacturer of medical grade TPU. We pay a high attention to consistency in terms of formulation as well as manufacturing process by maintaining the highest quality operational controls including change management system to ensure our commitment to meet and exceed our customers\u2019 expectations. ICP DAS medical grade TPUs have also been tested for biocompatibility conforming to standards such as ISO10993 and USP Class VI (Biological Safety Statement available upon request).<\/span><\/p><p><span style=\"color: #000000;\">The biocompatibility testing referenced above are only performed on ICP DAS TPU pellets and therefore make no representations regarding the suitability for use in any particular medical application. This Policy is intended to provide guidelines on whether ICP DAS supports the use of its products in customers\u2019 proposed medical applications requested through our Medical Application Screening Form.<\/span><\/p><p><span style=\"color: #000000;\">In reference to use of ISO 10993-1:2018 guidelines (Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process) on medical device categorization by contact duration, ICP DAS categorizes medical applications into the following three (3) categories:<\/span><\/p><ul><li><span style=\"color: #000000;\"><strong>Category A (Limited Contact)<\/strong>: Medical applications involving limited or transient contact (i.e., less than or equal to 24 hours) with a patient\u2019s skin, body fluids or tissues.<\/span><\/li><li><span style=\"color: #000000;\"><b>Category B (Prolonged Contact): <\/b>Medical applications involving prolonged contact (i.e., greater than 24 hours to 30 days) with a patient\u2019s skin, body fluids or tissues.<\/span><\/li><\/ul><p><span style=\"color: #000000;\">ICP DAS may support the use of ICP DAS medical grade TPU for Category A and Category B applications and will use its best business judgment to ensure specific corporate risk management conditions are met when supplying the materials.<\/span><\/p><ul><li><span style=\"color: #000000;\"><strong>Category C (Permanent Contact)<\/strong>: Medical applications involving permanent or long term contact (i.e., more than 30 days) with a patient\u2019s skin, body fluids, or tissues.<\/span><\/li><\/ul><p><span style=\"color: #000000;\">ICP DAS will <strong>not<\/strong> knowingly or implicitly support the use of ICP DAS medical grade TPU into any developmental or commercial component or product that is intended for Category C applications.<\/span><\/p><p><span style=\"color: #000000;\">While ICP DAS medical grade TPU pellets have been determined to be compliant with certain biocompatibility tests, ICP DAS makes no representations or warranties and accepts no responsibility, express or implied, concerning the suitability, safety or efficacy of any warning on losses or damages that may result from the use of ICP DAS medical grade TPU for any particular intermediate components or final products in medical applications. Any decision to determine any type of suitability (including biocompatibility) of ICP DAS medical grade TPU for its end use in any medical device applications should be solely based on the judgment of the manufacturer by conducting all necessary tests and evaluation under actual end-use requirements.<\/span><\/p><p><span style=\"color: #000000;\">Customers, distributors, or resellers shall neither use ICP DAS product names, trademarks and the ICP DAS name nor represent others that ICP DAS permits, recommends, or endorses the use of its products in any medical application.<\/span><\/p><p><span style=\"color: #000000;\">ICP DAS reserves the right to discourage their use of ICP DAS medical grade TPU if any identified or suspected act of non-compliance is discovered within the scope of this Policy.<\/span><\/p><p><span style=\"color: #000000;\">Revision date: 2-Aug-2021<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-c09667d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c09667d\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-86e2f98\" data-id=\"86e2f98\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-40410ab elementor-widget elementor-widget-image\" data-id=\"40410ab\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1\" height=\"1\" src=\"https:\/\/bmp.icpdas.com\/wordpress\/wp-content\/uploads\/2021\/09\/Medical-Application-Policy_20210903-1.jpg\" class=\"attachment-medium size-medium wp-image-1421\" alt=\"\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Medical Application Policy ICP DAS is a dedicated ISO13485:2016 certified manufacturer of medical grade TPU. We pay a high attention to consistency in terms of formulation as well as manufacturing<\/p><\/div>\n<div class=\"blog-btn\"><a href=\"https:\/\/bmp.icpdas.com\/wordpress\/medical-application-policy\/\" class=\"home-blog-btn\">Read More<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1418","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/bmp.icpdas.com\/wordpress\/wp-json\/wp\/v2\/pages\/1418","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bmp.icpdas.com\/wordpress\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/bmp.icpdas.com\/wordpress\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/bmp.icpdas.com\/wordpress\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bmp.icpdas.com\/wordpress\/wp-json\/wp\/v2\/comments?post=1418"}],"version-history":[{"count":67,"href":"https:\/\/bmp.icpdas.com\/wordpress\/wp-json\/wp\/v2\/pages\/1418\/revisions"}],"predecessor-version":[{"id":1644,"href":"https:\/\/bmp.icpdas.com\/wordpress\/wp-json\/wp\/v2\/pages\/1418\/revisions\/1644"}],"wp:attachment":[{"href":"https:\/\/bmp.icpdas.com\/wordpress\/wp-json\/wp\/v2\/media?parent=1418"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}