Décision du 19 août 2011 modifiant la décision du 20 octobre 2010 fixant la liste et les caractéristiques des produits sanguins labiles
Jurisdiction | France |
Date de publication | 02 octobre 2011 |
Enactment Date | 19 août 2011 |
Record Number | JORFTEXT000024614689 |
Publication au Gazette officiel | JORF n°0229 du 2 octobre 2011 |
Court | Ministère du travail, de l'emploi et de la santé |
ELI | https://www.legifrance.gouv.fr/eli/decision/2011/8/19/ETSM1120211S/jo/texte |
Le directeur général de l'Agence française de sécurité sanitaire des produits de santé,
Vu le code de la santé publique, notamment son article L. 1221-8 ;
Vu la décision du 20 octobre 2010 modifiée fixant la liste et les caractéristiques des produits sanguins labiles ;
Vu l'avis de l'Etablissement français du sang en date du 12 juillet 2011,
Décide :
La liste et les caractéristiques des produits sanguins labiles sont celles qui sont énoncées par la décision du 20 octobre 2010 susvisée, sous réserve des modifications suivantes qui sont introduites dans l'annexe II de ladite décision.
Dans les dispositions concernant le plasma frais congelé sécurisé, le point 4.4 intitulé « Plasma frais congelé viro-atténué par solvant-détergent » est remplacé par les dispositions suivantes :
« 4.4. Plasma frais congelé viro-atténué par solvant-détergent :
Dénomination courte : Plasma frais congelé viro-atténué par solvant-détergent.
Dénomination abrégée : PFC-SD.
Définition et description du plasma frais congelé d'aphérèse servant à préparer le PFC-SD :
― le volume minimal est de 200 ml en tenant compte du volume de la solution anticoagulante ;
― la teneur minimale en facteur VIII est de 0,7 UI/ml. La vérification de cette teneur doit être faite sur un mélange d'au moins 10...
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