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ISO 10993-1:2009
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
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Abstract
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.
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Edition: 4 (Monolingual) ICS: 11.100.20 Status: Published Stage: 60.60 (2009-10-13) TC/SC: ISO/TC 194 Number of Pages: 21 -
Revises: ISO 10993-1:2003
