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ISO 10993-1:2009

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

Oct 13, 2009
95.99   Withdrawal of Standard   Aug 17, 2018

General information

95.99     Aug 17, 2018

ISO

ISO/TC 194

International Standard

11.100.20  

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Scope

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.


Life cycle

PREVIOUSLY

WITHDRAWN
ISO 10993-1:2003

NOW

WITHDRAWN
ISO 10993-1:2009
95.99 Withdrawal of Standard
Aug 17, 2018

CORRIGENDA / AMENDMENTS

WITHDRAWN
ISO 10993-1:2009/Cor 1:2010

REVISED BY

PUBLISHED
ISO 10993-1:2018