Skip to main content
Back

ISO 10993-7:2008

Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals

General information

Withdrawn from 20.04.2026
Directives or regulations
None

Standard history

Status
Date
Type
Name
20.04.2026
Main
09.12.2019
Amendment
12.11.2009
Corrigendum
13.10.2008
Main
Main
ISO 10993-7:1995
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.

Required fields are indicated with *

*
*
*
PDF
89.37 € incl tax
Paper
89.37 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN ISO 14155:2020

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Withdrawn from 04.05.2026
Main

EVS-EN ISO 20417:2021

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
Withdrawn from 15.04.2026
Main

EVS-EN ISO 20417:2026

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2026)
Newest version Valid from 15.04.2026
Main

EVS-EN ISO 14155:2026

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2026)
Newest version Valid from 04.05.2026