{"id":608802,"date":"2024-11-05T22:43:37","date_gmt":"2024-11-05T22:43:37","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-236402011\/"},"modified":"2024-11-05T22:43:37","modified_gmt":"2024-11-05T22:43:37","slug":"iso-236402011","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-236402011\/","title":{"rendered":"ISO 23640:2011"},"content":{"rendered":"<p>ISO 23640:2011 is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. ISO 23640:2011 can also be applied to specimen collection devices that contain substances used  to preserve samples or to initiate reactions for further processing of the sample in the collection device.  <\/p>\n<p>ISO 23640:2011 specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in:<\/p>\n<ul>\n<li>       the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained; <\/li>\n<li>       the establishment of stability of the IVD reagent in use after the first opening of the primary container;<\/li>\n<li>       the monitoring of stability of IVD reagents already placed on the market;<\/li>\n<li>       the verification of stability specifications after modifications of the IVD reagent that might affect stability.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p><b>In vitro diagnostic medical devices \u2014 Evaluation of stability of in vitro diagnostic reagents<\/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\/iso\/\"><b>ISO<\/b><\/a><\/td>\n<td>2011-12<\/td>\n<td>12<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":608813,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[161,2634],"product_tag":[],"class_list":{"0":"post-608802","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-100-10","7":"product_cat-iso","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\/608802","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\/608813"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=608802"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=608802"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=608802"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}