{"id":513552,"date":"2024-11-05T14:24:40","date_gmt":"2024-11-05T14:24:40","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/can-csa-iso-14971-f07-c2017\/"},"modified":"2024-11-05T14:24:40","modified_gmt":"2024-11-05T14:24:40","slug":"can-csa-iso-14971-f07-c2017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/csa\/can-csa-iso-14971-f07-c2017\/","title":{"rendered":"CAN\/CSA-ISO 14971-F07 (C2017)"},"content":{"rendered":"<p><strong>Pr\u00e9face<\/strong><\/p>\n<p>Ce document constitue la deuxi\u00e8me \u00e9dition de la CAN\/CSA-ISO 14971, Dispositifs m\u00e9dicaux &#8211; Application de la gestion des risques aux dispositifs m\u00e9dicaux. Il s&#039;agit de l&#039;adoption, sans modifications, de la norme ISO (Organisation internationale de normalisation) 14971 (deuxi\u00e8me \u00e9dition, 2007-03-01), qui porte le m\u00eame titre. Cette norme remplace l&#039;\u00e9dition pr\u00e9c\u00e9dente publi\u00e9e en 2001 qui portait la d\u00e9signation CAN\/CSAISO 14971 (norme ISO 14971:2000 adopt\u00e9e) et la Modification 1:2003 \u00e0 la CAN\/CSA-ISO 14971:01 (Amendement 1:2003 de l&#039;ISO adopt\u00e9e).\u00a0<\/p>\n<p><strong>Domaine d&#039;application<\/strong><\/p>\n<p>La pr\u00e9sente Norme internationale sp\u00e9cifie un processus pour permettre au fabricant d&#039;identifier les ph\u00e9nom\u00e8nes dangereux et les situations dangereuses associ\u00e9s aux dispositifs m\u00e9dicaux, y compris les dispositifs m\u00e9dicaux de diagnostic in vitro (DIV), d&#039;estimer et d&#039;\u00e9valuer les risques, de ma\u00eetriser ces risques et de surveiller l&#039;efficacit\u00e9 de cette ma\u00eetrise.\u00a0<\/p>\n<p>Les exigences de la pr\u00e9sente Norme internationale s&#039;appliquent \u00e0 tous les stades du cycle de vie d&#039;un dispositif m\u00e9dical.\u00a0<\/p>\n<p>La pr\u00e9sente Norme internationale ne s&#039;applique pas \u00e0 la prise de d\u00e9cision clinique.\u00a0<\/p>\n<p>La pr\u00e9sente Norme internationale ne sp\u00e9cifie pas les niveaux d&#039;acceptabilit\u00e9 des risques.\u00a0<\/p>\n<p>La pr\u00e9sente Norme internationale n&#039;exige pas du fabricant qu&#039;il mette en place un syst\u00e8me de management de la qualit\u00e9. Toutefois, la gestion des risques peut faire partie int\u00e9grante d&#039;un syst\u00e8me de management de la qualit\u00e9.<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Dispositifs m\u00e9dicaux &#8211; Application de la gestion des risques aux dispositifs m\u00e9dicaux<\/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>2007<\/td>\n<td>106<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":513567,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[136,2674],"product_tag":[],"class_list":{"0":"post-513552","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-01","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\/513552","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\/513567"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=513552"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=513552"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=513552"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}