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ISO 10993-1:2009

Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

General information
Withdrawn from 17.08.2018
Directives or regulations
None
Standard history
Status
Date
Type
Name
17.08.2018
Main
Main
ISO 10993-1:2003
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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