Standard: AAMI 10993-7

BIOLOGICAL EVALUATION OF MEDICAL DEVICES-PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS

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Scope:

This part of ISO 10993 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 the informative annexes.

EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this part of ISO 10993.

NOTE This part of ISO 10993 does not specify limits for ethylene glycol (EG).

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 10993-7
Publish Date: 2008-01-01
Page Count: 114
Change Type: REAF
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
AAMI 10993-7 Change Type: ERTA Update Date: 2008-01-01 Revision: 08 Status: ACTV

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