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Provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding materials samples finished as ready for clinical use.
Author | ANSI/AAMI/ISO |
---|---|
Editor | AAMI |
Document type | Standard |
Format | File |
Confirmation date | 2011-11-16 |
ICS | 11.100.20 : Biological evaluation of medical devices |
Cross references | ISO 10993-15 (2000-12), IDT |
Year | 2000 |
Document history | |
Country | USA |
Keyword | ANSI 10993;ANSI/AAMI/ISO 10993;10993;ANSI/AAMI/ISO 10993-15-2000 (R2011) |