{"id":513486,"date":"2024-11-05T14:24:20","date_gmt":"2024-11-05T14:24:20","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/can-csa-iso-13488-f98\/"},"modified":"2024-11-05T14:24:20","modified_gmt":"2024-11-05T14:24:20","slug":"can-csa-iso-13488-f98","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/csa\/can-csa-iso-13488-f98\/","title":{"rendered":"CAN\/CSA-ISO 13488-F98"},"content":{"rendered":"<p><b>Domaine d&#039;application<\/b><\/p>\n<p>La pr\u00e9sente Norme internationale, conjointement avec l&#039;ISO 9002, prescrit les exigences relatives aux syst\u00e8mes qualit\u00e9 en mati\u00e8re de production, et lorsque c&#039;est appropri\u00e9, d&#039;installation des dispositifs m\u00e9dicaux et de prestations associ\u00e9es.<\/p>\n<p>La pr\u00e9sente Norme internationale, conjointement avec l&#039;ISO 9002, est applicable lorsqu&#039;il est n\u00e9cessaire d&#039;\u00e9valuer le syst\u00e8me qualit\u00e9 d&#039;un fournisseur de dispositifs m\u00e9dicaux.<\/p>\n<p>Dans le cadre de l&#039;\u00e9valuation par une tierce partie en ce qui concerne les exigences r\u00e9glementaires, il peut \u00eatre exig\u00e9 du fournisseur de permettre l&#039;acc\u00e8s \u00e0 des donn\u00e9es confidentielles pour d\u00e9montrer la conformit\u00e9 \u00e0 la pr\u00e9sente Norme internationale. Le fournisseur peut \u00eatre tenu de montrer ces donn\u00e9es mais n&#039;est pas oblig\u00e9 de fournir des copies pour conservation.<\/p>\n<p>NOTE &#8211; Dans la pr\u00e9sente Norme internationale, l&#039;expression \u00abs&#039;il y a lieu\u00bb est utilis\u00e9e plusieurs fois. Lorsque cette expression accompagne une exigence, on consid\u00e8re que celle-ci \u00abdoit \u00eatre respect\u00e9e\u00bb, sauf si le fournisseur peut justifier du contraire. Une exigence \u00abdoit \u00eatre respect\u00e9e\u00bb si son non-respect risque d&#039;avoir les cons\u00e9quences suivantes: <\/p>\n<ul>\n<li>  le produit n&#039;est pas conforme aux exigences prescrites; et\/ou<\/li>\n<li> le fournisseur n&#039;est pas en mesure de mener une action corrective.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p><b>Syst\u00e8mes qualit\u00e9 &#8211; Dispositifs m\u00e9dicaux &#8211; Exigences particuli\u00e8res relatives \u00e0 l\u2019application de l\u2019ISO 9002<\/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>2000-01-19<\/td>\n<td>21<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":513500,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[136,2674],"product_tag":[],"class_list":{"0":"post-513486","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\/513486","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\/513500"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=513486"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=513486"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=513486"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}