This standard has been revised by ISO 10993-1:2018
Abstract
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.
General information
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Status : WithdrawnPublication date : 2009-10
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Edition : 4Number of pages : 21
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- ICS :
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Biological evaluation of medical devices
Life cycle
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Previously
WithdrawnISO 10993-1:2003
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Now
Corrigenda / Amendments
WithdrawnISO 10993-1:2009/Cor 1:2010
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Revised by
PublishedISO 10993-1:2018
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