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Specifies requirements and gives guidance on the procedures to be followed in the evaluation of the potential for medical devices and their materials to cause adverse systemic reactions.
Author | ANSI/AAMI/ISO |
---|---|
Editor | AAMI |
Document type | Standard |
Format | File |
Confirmation date | 2014-09-24 |
ICS | 11.100.20 : Biological evaluation of medical devices |
Replace | ANSI/AAMI/ISO 10993-11 (1993) |
Cross references | ISO 10993-11 (2006-08), IDT |
Year | 2006 |
Document history | ANSI/AAMI/ISO 10993-11 (2006) |
Country | USA |
Keyword | ANSI 10993;ANSI/AAMI/ISO 10993;10993;ANSI/AAMI/ISO 10993-11-2006 (R2014) |