{"id":513416,"date":"2024-11-05T14:23:57","date_gmt":"2024-11-05T14:23:57","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/can-csa-iso-10993-3-f97-c2006\/"},"modified":"2024-11-05T14:23:57","modified_gmt":"2024-11-05T14:23:57","slug":"can-csa-iso-10993-3-f97-c2006","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/csa\/can-csa-iso-10993-3-f97-c2006\/","title":{"rendered":"CAN\/CSA-ISO 10993.3-F97 (C2006)"},"content":{"rendered":"<p><strong>Domaine d\u2019application<\/strong><\/p>\n<p>La pr\u00e9sente partie de l\u2019ISO 10993 prescrit des essais pour les aspects biologiques suivants:<br \/>&#8211; g\u00e9notoxicit\u00e9,<br \/>&#8211; canc\u00e9rogenicit\u00e9, et<br \/>&#8211; toxicit\u00e9 sur la reproduction et au cours du d\u00e9veloppement.<\/p>\n<p>Ces aspects concernent l\u2019\u00e9valuation biologique de certaines cat\u00e9gories de dispositifs m\u00e9dicaux (voir note 1). Les lignes directrices pour le choix des essais sont donn\u00e9es dans l\u2019ISO 10993-1. Lorsque le besoin d\u2019\u00e9valuer le potentiel de g\u00e9notoxicit\u00e9, de canc\u00e9rog\u00e9nicit\u00e9 ou de toxicit\u00e9 sur la reproduction a \u00e9t\u00e9 identifi\u00e9, il convient que cette \u00e9valuation soit effectu\u00e9e conform\u00e9ment \u00e0 la pr\u00e9sente partie de l\u2019ISO 10993.<\/p>\n<p>La plupart des essais inclus dans la pr\u00e9sente partie de l\u2019ISO 10993 se r\u00e9f\u00e8rent aux lignes directrices de lOCDE pour les essais de produits chimiques. La r\u00e9f\u00e9rence \u00e0 ces essais est d\u00e9sign\u00e9e par les termes \u00ablignes directrices OCDE\u00bb suivis par le num\u00e9ro de l\u2019essai appropri\u00e9. Au cours des \u00e9valuations, ces essais seront accomplis conform\u00e9ment aux guides OCDE en cours de validit\u00e9.<\/p>\n<p><strong>NOTE 1<\/strong><br \/>Le terme \u00abdispositif\u00bb correspond \u00e0 la d\u00e9finition donn\u00e9e dans l\u2019ISO 10993-1 et couvre les mat\u00e9riaux, ainsi que les mat\u00e9riaux et dispositifs dentaires. La d\u00e9finition est conforme \u00e0 la norme CEN.<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>\u00c9valuation biologique des dispositifs m\u00e9dicaux &#8211; Partie 3: Essais concernant la g\u00e9notoxicit\u00e9, la canc\u00e9rog\u00e9nicit\u00e9 et la toxicit\u00e9 sur la reproduction<\/b><\/p>\n<table style=\"width: 100%\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>Published By<\/td>\n<td>Publication Date<\/td>\n<td>Number of Pages<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/pdfstandards.shop\/product-category\/publishers\/csa\/\"><b>CSA<\/b><\/a><\/td>\n<td>2000-01-18<\/td>\n<td>21<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":513430,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2674],"product_tag":[],"class_list":{"0":"post-513416","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-100-20","7":"product_cat-csa","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/513416","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/513430"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=513416"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=513416"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=513416"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}