Draft International Standard
ISO/DIS 10993-7
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
Reference number
ISO/DIS 10993-7
Edición 3
Draft
International Standard
ISO/DIS 10993-7
84824
Este borrador de Norma Internacional se encuentra en la fase de consultas con los miembros de ISO.
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

  •  : En desarrollo
    : DIS registrado [40.00]
  •  : 3
     : 118
  • ISO/TC 194
    11.100.20 
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