{"id":590307,"date":"2024-11-05T21:12:57","date_gmt":"2024-11-05T21:12:57","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-13408-22018\/"},"modified":"2024-11-05T21:12:57","modified_gmt":"2024-11-05T21:12:57","slug":"iso-13408-22018","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-13408-22018\/","title":{"rendered":"ISO 13408-2:2018"},"content":{"rendered":"

ISO 13408-2:2018 sp\u00e9cifie les exigences de filtration st\u00e9rilisante dans le cadre du traitement aseptique des produits de sant\u00e9, men\u00e9 conform\u00e9ment \u00e0 ISO 13408-1. Il propose \u00e9galement aux utilisateurs de filtres des recommandations concernant les exigences g\u00e9n\u00e9rales pour la configuration, la validation et les op\u00e9rations de routine d'un processus de filtration st\u00e9rilisante.<\/p>\n

ISO 13408-2:2018 ne concerne pas l'\u00e9limination des virus.<\/p>\n

La filtration st\u00e9rilisante ne s'applique pas aux fluides contenant volontairement des particules de taille sup\u00e9rieure \u00e0 la dimension des pores du filtre (par exemple: vaccins \u00e0 cellules bact\u00e9riennes enti\u00e8res).<\/p>\n

ISO 13408-2:2018 ne s'applique pas aux filtres HEPA (High Efficiency Particulate Air).<\/p>\n

ISO 13408-2:2018 ne sp\u00e9cifie pas d'exigences relatives \u00e0 l'\u00e9laboration, \u00e0 la validation et au contr\u00f4le de routine d'un processus d'\u00e9limination des agents de prolif\u00e9ration de l'enc\u00e9phalopathie spongiforme, telle que la tremblante du mouton, l'enc\u00e9phalopathie spongiforme bovine et la maladie de Creutzfeldt-Jakob. Des recommandations sp\u00e9cifiques ont \u00e9t\u00e9 r\u00e9dig\u00e9es dans des pays d\u00e9termin\u00e9s pour le traitement des mat\u00e9riaux potentiellement contamin\u00e9s par ces agents.<\/p>\n","protected":false},"excerpt":{"rendered":"

Traitement aseptique des produits de sant\u00e9 \u2014 Partie 2: Filtration st\u00e9rilisante<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
ISO<\/b><\/a><\/td>\n2018-01<\/td>\n42<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":590318,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2634],"product_tag":[],"class_list":{"0":"post-590307","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-01","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\/590307","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\/590318"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=590307"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=590307"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=590307"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}