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Specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of the ISO 10993 series. Includes extraction procedures and soluble polymer procedures.
Author | ANSI/AAMI/ISO |
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Editor | AAMI |
Document type | Standard |
Format | File |
Confirmation date | 2012-07-26 |
ICS | 11.100.20 : Biological evaluation of medical devices |
Replace | ANSI/AAMI/ISO 10993-12 (2007) |
Cross references | ISO 10993-12 (2012-07), IDT |
Year | 2012 |
Document history | ANSI/AAMI/ISO 10993-12 (2012) |
Country | USA |
Keyword | ANSI 10993;ANSI/AAMI/ISO 10993;10993;ANSI/AAMI/ISO 10993-12-2012 |