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Historical Revision

ISO 10993-1:2009

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
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ISO 10993-1:2009

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

PUBLISH DATE 2009
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.
SDO ISO: International Organization for Standardization
Document Number ISO 10993
Publication Date Oct. 15, 2009
Language en - English
Page Count
Revision Level
Supercedes
Committee
Publish Date Document Id Type View
Not Available ISO 10993-1:2025 Revision
Aug. 1, 2018 ISO 10993-1:2018 Revision
Oct. 15, 2009 ISO 10993-1:2009 Revision