This standard was last reviewed and confirmed in 2022. Therefore this version remains current.
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.
Status: PublishedPublication date: 2011-12
Corrected version (en): 2012-10
Edition: 1Number of pages: 585
Technical Committee: ISO/TC 215 Health informatics
- ICS :
- 35.240.80 IT applications in health care technology
This standard contributes to the following Sustainable Development Goals:
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A standard is reviewed every 5 years
Stage: 90.93 (Confirmed)
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