Norm

NEN-EN-ISO 10993-17:2009 en

Biologische evaluatie van medische hulpmiddelen - Deel 17: Vaststellen van toelaatbare grenzen voor uitlogende stoffen

106,87

Over deze norm

Status Definitief
Aantal pagina's 25
Commissie Biocompatibiliteit en biologisch onderzoek
Gepubliceerd op 01-05-2009
Taal Engels
This part of ISO 10993 specifies a method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. This part of ISO 10993 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices). Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. This part of ISO 10993 does not address the potential for exposure from such sources.

Details

ICS-code 11.100.20
Nederlandse titel Biologische evaluatie van medische hulpmiddelen - Deel 17: Vaststellen van toelaatbare grenzen voor uitlogende stoffen
Engelse titel Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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