Norm

ISO 14971-1:1998 en

Medische hulpmiddelen - Risicomanagement - Deel 1: Toepassing van risico-analyse

  • Deze norm is ingetrokken sinds 01-12-2000

73,12

Over deze norm

Status Ingetrokken
Aantal pagina's 17
Commissie Medische hulpmiddelen - horizontale onderwerpen
Gepubliceerd op 01-10-1998
Taal Engels
Specifies a procedure for investigating, using available information, the safety of a medical device, including in vitro diagnostic devices (IVD) or accessories, by identifying hazards and estimating the risks associated with the device. It may be of particular assistance in areas where relevant standards are not available or not used. This part of ISO 14971 does not stipulate levels of acceptability because these are determined by a multiplicity of factors that cannot be set down in such a standard. This part of ISO 14971 is not intended to give guidance on all aspects of management of risks. Furthermore, it is not intended to cover decision-making processes regarding assessment of the indications and contra-indications for the use of a particular device.

Details

ICS-code 11.020
Nederlandse titel Medische hulpmiddelen - Risicomanagement - Deel 1: Toepassing van risico-analyse
Engelse titel Medical devices - Risk management - Part 1: Application of risk analysis
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