{"id":521101,"date":"2024-11-05T15:02:48","date_gmt":"2024-11-05T15:02:48","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/csa-iso-tr-24971f21\/"},"modified":"2024-11-05T15:02:48","modified_gmt":"2024-11-05T15:02:48","slug":"csa-iso-tr-24971f21","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/csa\/csa-iso-tr-24971f21\/","title":{"rendered":"CSA ISO\/TR 24971:F21"},"content":{"rendered":"<p><strong>Pr\u00e9face CSA<\/strong><\/p>\n<p><\/p>\n<p>Ce document constitue la premi\u00e8re \u00e9dition de CSA ISO\/TR 24971, <em>Dispositifs m\u00e9dicaux \u2014 Recommandations relatives \u00e0 l\u2019application de l\u2019ISO 14971.<\/em> Il s\u2019agit de l\u2019adoption, sans modification, de la rapport technique ISO (Organisation internationale de normalisation) 24971 (deuxi\u00e8me \u00e9dition, 2020-06), qui porte le m\u00eame titre.<\/p>\n<p><\/p>\n<p>Groupe CSA tient \u00e0 souligner que l\u2019\u00e9laboration de cette norme a \u00e9t\u00e9 rendue possible, en partie, par le soutien financier des gouvernements de l\u2019Alberta, de la Colombie-Britannique, du Manitoba, du Nouveau-Brunswick, de Terre-Neuve-et-Labrador, des Territoires du Nord-Ouest, de la Nouvelle-\u00c9cosse, du Nunavut, de l\u2019Ontario, de l\u2019\u00cele-du-Prince-\u00c9douard, du Qu\u00e9bec, de la Saskatchewan et du Yukon, tel qu\u2019administr\u00e9 par l\u2019Agence canadienne des m\u00e9dicaments et des technologies de la sant\u00e9 (ACMTS).<\/p>\n<p><\/p>\n<p>Cette norme a \u00e9t\u00e9 \u00e9labor\u00e9e conform\u00e9ment aux exigences du Conseil canadien des normes concernant les Normes nationales du Canada. Cette norme a \u00e9t\u00e9 publi\u00e9e en tant que Norme nationale du Canada par Groupe CSA.<\/p>\n<p><\/p>\n<p><strong>Domaine d\u2019application<\/strong><\/p>\n<p><\/p>\n<p>Le pr\u00e9sent document fournit des recommandations relatives au d\u00e9veloppement, \u00e0 la mise en \u0153uvre et \u00e0 la tenue \u00e0 jour d\u2019un syst\u00e8me de gestion des risques pour les dispositifs m\u00e9dicaux conform\u00e9ment \u00e0 l\u2019ISO 14971:2019.<\/p>\n<p><\/p>\n<p>Le processus de gestion des risques peut faire partie d\u2019un syst\u00e8me de management de la qualit\u00e9 qui s\u2019appuie, par exemple, sur l\u2019ISO 13485:2016 [24], mais cela n\u2019est pas requis par l\u2019ISO 14971:2019. Certaines exigences de l\u2019ISO 13485:2016 (Article 7 relatif \u00e0 la r\u00e9alisation du produit et 8.2.1 relatives aux retours d\u2019information au cours de la surveillance et du mesurage) portent sur la gestion des risques et peuvent \u00eatre satisfaites en appliquant l\u2019ISO 14971:2019. Voir \u00e9galement le manuel ISO: ISO 13485:2016 \u2014 Medical devices \u2014 A practical guide[25].<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Dispositifs m\u00e9dicaux \u2014 Recommandations relatives \u00e0 l\u2019application de l\u2019ISO 14971<\/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>2021<\/td>\n<td>121<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":521108,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2674],"product_tag":[],"class_list":{"0":"post-521101","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-csa","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/521101","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\/521108"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=521101"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=521101"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=521101"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}