SS-EN ISO 10993-1:2009
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)
Hardcopy
English
26-10-2009
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This part of ISO 10993 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 |
TC 194
|
| DocumentType |
Standard
|
| Pages |
0
|
| PublisherName |
Standardiserings-Kommissionen I Sverige
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 10993-1:2009 | Identical |
| ISO 10993-1:2009 | Identical |
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