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SN EN ISO 10993-1:2010

Current
Current

The latest, up-to-date edition.

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
Available format(s)

Hardcopy

Published date

03-01-2010

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.

Committee
INB/NK 129
DocumentType
Standard
Pages
0
PublisherName
Swiss Standards
Status
Current

Standards Relationship
EN ISO 10993-1:2009 Identical
ISO 10993-1:2009 Identical

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