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The standard provides a classification of medical and dental devices that are intended for use in contact with blood based on the intended use and duration of contact as defined in ISO 10993-1, the fundamental principles governing the evaluation of the interaction of devices with blood, and the rationale for structured selection of tests.
Author | ANSI/AAMI/ISO |
---|---|
Editor | AAMI |
Document type | Standard |
Format | File |
Confirmation date | 2013-11-26 |
ICS | 11.100.20 : Biological evaluation of medical devices |
Cross references | ISO 10993-4 (2002-10), IDT |
Modified by | ANSI/AAMI/ISO 10993-4 AMD 1 (2006) |
Year | 2002 |
Document history | |
Country | USA |
Keyword | ANSI 10993;ANSI/AAMI/ISO 10993;10993;ANSI/AAMI/ISO 10993-4:2002 (R2013) |