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SR EN ISO 10993-1:2010

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

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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Status : Withdrawn
Approval date : 1/29/2010
Publish date : 1/31/2010
Withdrawal date : 1/29/2021
Number of pages : 32
ICS : 11.100.20 Biological evaluation of medical devices
Technical Committee : 377 - Medical devices

Relations with other standards: