{"id":605544,"date":"2024-11-05T22:28:40","date_gmt":"2024-11-05T22:28:40","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-21474-22022\/"},"modified":"2024-11-05T22:28:40","modified_gmt":"2024-11-05T22:28:40","slug":"iso-21474-22022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-21474-22022\/","title":{"rendered":"ISO 21474-2:2022"},"content":{"rendered":"

Le pr\u00e9sent document donne les exigences g\u00e9n\u00e9rales de validation et de v\u00e9rification des tests mol\u00e9culaires multiplex qui identifient simultan\u00e9ment deux s\u00e9quences cibles d\u2019acide nucl\u00e9ique d\u2019int\u00e9r\u00eat ou plus. Le pr\u00e9sent document est applicable \u00e0 toutes les m\u00e9thodes multiplex utilis\u00e9es pour analyser les dispositifs m\u00e9dicaux DIV et les tests d\u00e9velopp\u00e9s en laboratoire (TDL). Il fournit des informations sur la d\u00e9tection qualitative et quantitative des s\u00e9quences cibles d\u2019acide nucl\u00e9ique.<\/p>\n

Le pr\u00e9sent document est con\u00e7u comme une recommandation pour les analyses multiplex qui d\u00e9tectent et\/ou quantifient les s\u00e9quences cibles d\u2019acide nucl\u00e9ique humain ou les s\u00e9quences cibles d\u2019acide nucl\u00e9ique pathog\u00e8ne microbien dans les \u00e9chantillons cliniques humains.<\/p>\n

Il est applicable aux analyses de diagnostic in vitro<\/em> (DIV) mol\u00e9culaires effectu\u00e9es par les laboratoires m\u00e9dicaux. Il est \u00e9galement destin\u00e9 \u00e0 \u00eatre utilis\u00e9 par des clients de laboratoires, des d\u00e9veloppeurs et fabricants de l\u2019industrie du DIV, ainsi que par des biobanques, des institutions et des organismes commerciaux sp\u00e9cialis\u00e9s en recherche biom\u00e9dicale, de m\u00eame que des autorit\u00e9s de r\u00e9glementation. Le pr\u00e9sent document n\u2019est pas applicable \u00e0 la m\u00e9tag\u00e9nomique.<\/p>\n

NOTE\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Un mode op\u00e9ratoire d\u2019analyse d\u00e9velopp\u00e9 pour le propre usage d\u2019un laboratoire est souvent appel\u00e9 \u00abtest d\u00e9velopp\u00e9 en laboratoire\u00bb, \u00abTDL\u00bb ou \u00abtest interne\u00bb.<\/p>\n","protected":false},"excerpt":{"rendered":"

Dispositifs m\u00e9dicaux de diagnostic in vitro \u2013 Tests mol\u00e9culaires multiplex pour les acides nucl\u00e9iques \u2014 Partie 2: Validation et v\u00e9rification<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
ISO<\/b><\/a><\/td>\n2022-05<\/td>\n24<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":605556,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[161,2634],"product_tag":[],"class_list":{"0":"post-605544","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\/605544","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\/605556"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=605544"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=605544"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=605544"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}