Superseded
Standard
Historical
NBN EN ISO 10993-1 (12/2009):2009
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
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Summary
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.
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.
Technical characteristics
| Publisher | Bureau de Normalisation Belge (NBN) |
| Publication Date | 12/16/2009 |
| Cancellation Date | 04/30/2010 |
| Page Count | 0 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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