Résumé
ISO/TS 19218-1:2011 specifies requirements for a hierarchical coding structure for describing adverse events relating to medical devices. The codes are intended for use by medical device users, manufacturers, regulatory authorities, health care facilities and other organizations. The codes can be used for coding events that are not related to death or serious injury, or malfunctions that could lead to death or serious injury.
ISO/TS 19218-1:2011 is not intended to be used to decide whether an incident is reportable or not.
Informations générales
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État actuel: AnnuléeDate de publication: 2011-05Stade: Annulation de la Norme internationale [95.99]
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Edition: 1
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Comité technique :ISO/TC 210
- RSS mises à jour
Cycle de vie
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Précédemment
AnnuléeISO/TS 19218:2005
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Actuellement
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00
Préliminaire
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10
Proposition
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20
Préparation
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30
Comité
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40
Enquête
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50
Approbation
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60
Publication
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90
Examen
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95
Annulation
Rectificatifs techniques / Amendements
AnnuléeISO/TS 19218-1:2011/Amd 1:2013
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00
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