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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Withdrawn from 17.08.2018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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