Norm

NEN-EN 1441:1994 Ontw. en

Medische hulpmiddelen - Risico-analyse

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Over deze norm

Status Ingetrokken
Aantal pagina's 15
Commissie Medische hulpmiddelen - horizontale onderwerpen
Gepubliceerd op 01-10-1994
Taal Engels
This standard specifies a procedure to investigate, using available information, the safety of a medical device including in vitro diagnostic devices or accessories, by identifying hazards and estimating the risks associated with the device. It is of particular assistance in areas where appropriate harmonized standards are not available or not used. This standard does not stipulate levels of acceptability, which because they are determined by a multiplicity of factors, cannot by their nature be set down in such a standard. This standard is not intended to give detailed guidance on risk management. Furthermore, it is not intended to cover decision-making processes regarding assessment of the indications and contra-indications for these of a particular device.

Details

ICS-code 11.040.01
Nederlandse titel Medische hulpmiddelen - Risico-analyse
Engelse titel Medical devices - Risk analysis
Vervangen door
Normatieve verwijzingen
  • 90/385/EEG, Actieve implanteerbare medische hulpmiddelen (pacemaker richtlijn)

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