ISO/HL7 27953-2:2011
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ISO/HL7 27953-2:2011
53825
Status : Published (Under review)
This standard was last reviewed and confirmed in 2022. Therefore this version remains current.
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Format Language
std 1 208 HTML
std 2 208 HTML on CD
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Abstract

ISO 27593-2:2011 seeks to create a standardized framework for international regulatory reporting and information sharing by providing a common set of data elements and a messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), infections, and incidents that can occur upon the administration of one or more human pharmaceutical products to a patient, regardless of source and destination.

General information

  •  : Published
     : 2011-12
     : 2012-10
    : International Standard confirmed [90.93]
  •  : 1
     : 585
  • ISO/TC 215
    35.240.80 
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