ISO 10993-1:2009

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

Published By	Publication Date	Number of Pages
ISO	2009-10	28

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Categories: 11.100.20 - Biological evaluation of medical devices, ISO

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Description

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.

Additional information

Published Code	ISO
Published By	International Organization for Standardization
Publication Date	2009-10
Pages Count	28
Language	English
Edition	4
File Size	696.3 KB
ICS Codes	11.100.20 - Biological evaluation of medical devices