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| Standard
No. |
ISO 10993 - 1 : 2009 |
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| Title |
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| Edition |
2009 |
| No. of
Pages |
21 |
| ICS
Classification |
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| Comments |
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| Synopsis |
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.
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| Adoption |
ISO |
| Committee |
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| Preview
Document |
Not Available |
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| Status |
Current |
| Available
for Purchase |
For sale in Singapore only |
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