ISO 10993-1:2009 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.
Status: WithdrawnPublication date: 2009-10
Edition: 4Number of pages: 21
Technical Committee: ISO/TC 194 Biological and clinical evaluation of medical devices
- ICS :
- 11.100.20 Biological evaluation of medical devices
ISO 10993-1:2009Stage: 95.99
Corrigenda / AmendmentsWithdrawn
ISO 10993-1:2009/Cor 1:2010
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