ISO/FDIS 10993-7

En desarrollo

Este borrador está en fase de aprobación.

Reemplazará ISO 10993-7:2008

Resumen

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.

Informaciones generales

Estado
: En desarrollo

Etapa
: Texto final recibido o FDIS registrado para su aprobación formal [50.00]
Edición
: 3
Comité Técnico :
ISO/TC 194

ICS :
11.100.20
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