{"id":639832,"date":"2024-11-06T01:13:37","date_gmt":"2024-11-06T01:13:37","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-tr-181122006\/"},"modified":"2024-11-06T01:13:37","modified_gmt":"2024-11-06T01:13:37","slug":"iso-tr-181122006","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-tr-181122006\/","title":{"rendered":"ISO\/TR 18112:2006"},"content":{"rendered":"
ISO\/TR 18112:2006 summarizes regulatory requirements and associated guidance for information supplied by the manufacturer with IVD medical devices intended for professional use. <\/p>\n
Information supplied by the manufacturer includes labels on the outer and immediate container as well as instructions for use. <\/p>\n
Current labelling regulations and regulatory guidance from Canada, the European Union, Japan and the United States are included.<\/p>\n
Labelling guidance from the Global Harmonization Task Force and proposed labelling regulations from Australia are included for comparison. <\/p>\n
IVD medical devices for self-testing are excluded. <\/p>\n","protected":false},"excerpt":{"rendered":"
Clinical laboratory testing and in vitro diagnostic test systems \u2014 In vitro diagnostic medical devices for professional use \u2014 Summary of regulatory requirements for information supplied by the manufacturer<\/b><\/p>\n\n\n
\n Published By<\/td>\n Publication Date<\/td>\n Number of Pages<\/td>\n<\/tr>\n \n ISO<\/b><\/a><\/td>\n 2006-01<\/td>\n 128<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":639845,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[161,2634],"product_tag":[],"class_list":{"0":"post-639832","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\/639832","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\/639845"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=639832"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=639832"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=639832"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}