Résumé
ISO 12891-1:2015 specifies the method to be followed for the retrieval and handling of surgical implants and associated tissues and fluids. In particular, it specifies the essential steps to be followed for the safe and proper obtaining of the clinical history, pre-explantation checks and examinations, collection, labelling, cleaning, decontamination, documentation, packing and shipping. It also provides guidance on infection control.
NOTE National or other regulations, which can be more stringent, can apply.
ISO 12891-1:2015 does not apply in cases of explantation where there is no intention to collect retrieval data. However, many clauses give useful information which can apply in these cases also.
Informations générales
-
État actuel: PubliéeDate de publication: 2015-07Stade: Norme internationale à réviser [90.92]
-
Edition: 3
-
Comité technique :ISO/TC 150ICS :11.040.40
- RSS mises à jour
Cycle de vie
-
Précédemment
AnnuléeISO 12891-1:2011
-
Actuellement
PubliéeISO 12891-1:2015
Les normes ISO sont réexaminées tous les cinq ans
Stade: 90.92 (Sera révisée) -
Sera remplacée par
ProjetISO/AWI 12891-1