Norm

NEN-EN-ISO 27953-1:2009 Ontw. en

Medische informatica - Geneesmiddelenbewaking - Individuele meldingen van bijwerkingen - Deel 1: Het kader voor het melden van bijwerkingen

  • Deze norm is ingetrokken sinds 26-07-2010

58,21

Over deze norm

Status Ingetrokken
Aantal pagina's 108
Commissie Informatievoorziening in de zorg
Gepubliceerd op 01-06-2009
Taal Engels
Part 1 of this standard seeks to establish an international framework for data exchange and information sharing by providing a common messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), product problems and consumer complaints that may occur upon the administration or use of one or more products. Part 1 is based upon the HL7 Reference Information Model and can be extended or constrained to accommodate a variety of reporting requirements based upon ISO 27953-2 and other regional and international requirements summarized in the storyboard section of this ballot. It should be noted that Part 1 will be harmonized over time with other HL7 public health and patient safety incident reporting standards to help ensure messaging constructs and vocabulary are harmonized across the PORR domain. Furthermore, Part 1 of this standard does not govern or dictate reporting requirements for any product. The use cases (storyboards) described in this standard are for demonstration purposes only and are provided to help demonstrate the standard's scalability and interoperability across multiple stakeholders and product types. Future releases of this standard may be developed to include conformance profiles and vocabulary for all or a limited subset of the use cases.

Details

ICS-code 35.240.80
Nederlandse titel Medische informatica - Geneesmiddelenbewaking - Individuele meldingen van bijwerkingen - Deel 1: Het kader voor het melden van bijwerkingen
Engelse titel Health informatics - Pharmacovigilance - Individual case safety report - Part 1: The framework for adverse event reporting
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