ISO 10993-1
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DIN EN ISO 10993-1 |
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| Area | Medical technology, testing laboratories |
| title | Biological assessment of medical devices - Part 1: Assessment and testing as part of a risk management process |
| Latest edition | 2010-04 |
| ISO | 10993-1 |
The ISO standard 10993-1 with the title "Biological assessment of medical devices - Part 1: Assessment and testing as part of a risk management process" is part of the ISO 10993 series of standards .
The aim of this part is to protect people from possible biological risks that result from the use of medical devices. The standard explains instructions for assessing medical devices as part of a risk management process . A review and evaluation from all accessible sources and, if necessary, from additional tests, is used for a complete assessment.