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AAMI/ISO 10993-7:2008 (R2012)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residualsMore info
AAMI/ISO 10993-7 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how this document is applied, are also included in informative annexes. EO-sterilized devices that have no patient contact (e. g., in vitro diagnostic devices) are not covered by this standard.
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2012-06-01 |
| ICS | 11.100.20 : Biological evaluation of medical devices |
| Replace | ANSI/AAMI/ISO 10993-7 (1995) |
| Cross references | ISO 10993-7 (2008-10), IDT |
| Year | 2008 |
| Document history | ANSI/AAMI/ISO 10993-7 (2008) |
| Country | USA |
| Keyword | ANSI 10993;ANSI/AAMI/ISO 10993;10993;ANSI/AAMI/ISO 10993-7-2008 (R2012) |