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Provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.
Author | ANSI/AAMI/ISO |
---|---|
Editor | AAMI |
Document type | Standard |
Format | File |
Confirmation date | 2014-10-08 |
ICS | 11.100.20 : Biological evaluation of medical devices |
Replace | ANSI/AAMI/ISO 10993-13 (1999) |
Cross references | ISO 10993-13 (2010-06), IDT |
Year | 2010 |
Document history | ANSI/AAMI/ISO 10993-13 (2010) |
Country | USA |
Keyword | ANSI 10993;ANSI/AAMI/ISO 10993;10993;ANSI/AAMI/ISO 10993-13-2010 (R2014) |