ISO/FDIS 10993-7

This draft is in the approval phase.

Will replace ISO 10993-7:2008

Abstract

ISO 10993-7:2008 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 the standard 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 ISO 10993-7:2008.

General information

Status
: Under development

Stage
: Final text received or FDIS registered for formal approval [50.00]
Edition
: 3
Technical Committee :
ISO/TC 194

ICS :
11.100.20
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