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ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
| Author | ISO/TC 194 Biological and clinical evaluation of medical devices |
|---|---|
| Editor | ISO |
| Document type | Standard |
| Format | Paper |
| Edition | 3 |
| ICS | 11.100.20 : Biological evaluation of medical devices |
| Number of pages | 29 |
| Replace | ISO 10993-11:2006 |
| Weight(kg.) | 0.1493 |
| Year | 2017 |
| Country | Switzerland |