Norm

NEN-EN-ISO 10993-1:2009-10 en

Biologische evaluatie van medische hulpmiddelen - Deel 1: Evaluatie en beproeving met binnen risicomanagement proces

Volledig inclusief:

106,87

Over deze norm

Status Definitief
Aantal pagina's 21
Commissie Biocompatibiliteit en biologisch onderzoek
Gepubliceerd op 01-10-2009
Taal Engels
This part of ISO 10993 describes: - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of devices based on the nature and duration of their contact with the body; - the evaluation of existing relevant data from all sources; - the identification of gaps in the available data set on the basis of a risk analysis; - the identification of additional data sets necessary to analyse the biological safety of the medical device; - the assessment of the biological safety of the medical device. This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests, as indicated in the Foreword.

Details

ICS-code 11.100.20
Nederlandse titel Biologische evaluatie van medische hulpmiddelen - Deel 1: Evaluatie en beproeving met binnen risicomanagement proces
Engelse titel Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Vervangt
Gewijzigd door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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