{"id":603400,"date":"2024-11-05T22:19:06","date_gmt":"2024-11-05T22:19:06","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-20166-42021\/"},"modified":"2024-11-05T22:19:06","modified_gmt":"2024-11-05T22:19:06","slug":"iso-20166-42021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-20166-42021\/","title":{"rendered":"ISO 20166-4:2021"},"content":{"rendered":"<p>Le pr\u00e9sent document sp\u00e9cifie des exigences et formule des recommandations concernant le pr\u00e9l\u00e8vement, la manipulation, la documentation, le transport, le stockage et le traitement durant la phase pr\u00e9analytique de pr\u00e9l\u00e8vements de tissus fix\u00e9s au formol et inclus en paraffine (FFPE) destin\u00e9s \u00e0 l\u2019analyse <em>in\u00a0situ<\/em> qualitative et\/ou (semi-)quantitative de la morphologie et de biomol\u00e9cules, telles que des m\u00e9tabolites, des prot\u00e9ines, l\u2019ADN et\/ou l\u2019ARN sur des coupes de tissu FFPE \u00e0 l\u2019aide de diff\u00e9rentes techniques de d\u00e9tection <em>in\u00a0situ<\/em>.<\/p>\n<p>Le pr\u00e9sent document s\u2019applique aux analyses de diagnostic <em>in\u00a0vitro<\/em>, utilisant des techniques de d\u00e9tection <em>in\u00a0situ<\/em>. Celles-ci englobent les analyses d\u00e9velopp\u00e9es en laboratoire r\u00e9alis\u00e9es par des laboratoires de pathologie (laboratoires d\u2019histopathologie) ainsi que par des laboratoires de pathologie mol\u00e9culaire et autres laboratoires de biologie m\u00e9dicale. Il est \u00e9galement destin\u00e9 \u00e0 \u00eatre utilis\u00e9 par des clients de laboratoires, des d\u00e9veloppeurs et fabricants de l\u2019industrie du diagnostic <em>in\u00a0vitro<\/em>, des biobanques, ainsi que par des institutions et des organismes commerciaux sp\u00e9cialis\u00e9s en recherche biom\u00e9dicale, de m\u00eame que des autorit\u00e9s de r\u00e9glementation.<\/p>\n<p>Le pr\u00e9sent document ne s\u2019applique pas \u00e0 la phase pr\u00e9analytique de l\u2019analyse d\u2019ARN, de prot\u00e9ines et d\u2019ADN extraits de tissus FFPE, ces biomol\u00e9cules \u00e9tant respectivement couvertes par les normes ISO\u00a020166-1, ISO\u00a020166-2 et ISO\u00a020166-3, Analyses de diagnostic mol\u00e9culaire <em>in\u00a0vitro<\/em>\u00a0\u2014 Sp\u00e9cifications relatives aux processus pr\u00e9analytiques pour l\u2019ARN extrait, les prot\u00e9ines extraites et l\u2019ADN extrait.<\/p>\n<p>Des mesures sp\u00e9ciales diff\u00e9rentes sont prises pour les processus pr\u00e9analytiques applicables aux pr\u00e9l\u00e8vements de biopsie \u00e0 l\u2019aiguille fine (BAF). Les mesures applicables aux diff\u00e9rents pr\u00e9l\u00e8vements BAF (ARN cellulaire extrait, prot\u00e9ines extraites, et ADN g\u00e9nomique extrait) sont respectivement trait\u00e9es par les CEN\u00a0WI\u00a000140128, CEN\u00a0WI\u00a000140126, et CEN\u00a0WI\u00a000140129, Molecular <em>in\u00a0vitro<\/em> diagnostic examinations\u00a0\u2014 Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) isolated cellular RNA, isolated proteins, and isolated genomic DNA (disponibles en anglais seulement).<\/p>\n<p>NOTE\u00a0\u00a0 Des r\u00e9glementations ou exigences internationales, nationales ou r\u00e9gionales peuvent \u00e9galement s\u2019appliquer \u00e0 des sujets sp\u00e9cifiques trait\u00e9s dans le pr\u00e9sent document.<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Analyses de diagnostic mol\u00e9culaire in vitro \u2014 Sp\u00e9cifications relatives aux processus pr\u00e9 analytiques pour les tissus fix\u00e9s au formol et inclus en paraffine (FFPE) \u2014 Partie 4: Techniques de d\u00e9tection in situ<\/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>2021-07<\/td>\n<td>36<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":603413,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[161,2634],"product_tag":[],"class_list":{"0":"post-603400","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\/603400","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\/603413"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=603400"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=603400"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=603400"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}