Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals, includes Errata (2010)

Publisher:
Association for the Advancement of Medical Instrumentation/International Org. for Standardization

Document status:

Active

Format:

Electronic (PDF)

Delivery time:

10 minutes

Delivery time (for Russian version):

200 business days

SKU:

Includes a January 2010 erratum at the end.

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, is 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.

ANSI :	ANSI Approved
File Size :	1 file , 1.7 MB
ISBN(s) :	1570203326
Note :	This product is unavailable in Ukraine, Russia, Belarus
Number of Pages :	112
Part of :	AAMI STBK10-3
Published :	12/10/2007

AAMI/ISO 10993-7:2008/(R)2012 PDF

Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals, includes Errata (2010)

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