0 Items
My account
Phone: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Standards sales: prodaja@iss.rs Education: iss-edukacija@iss.rs Information about standards: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Main menu

ISO/FDIS 10993-7

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

General information

50.20     Nov 21, 2025

ISO

ISO/TC 194

International Standard

11.100.20  

Scope

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.

Life cycle

PREVIOUSLY

PUBLISHED
ISO 10993-7:2008

PUBLISHED
ISO 10993-7:2008/Cor 1:2009

PUBLISHED
ISO 10993-7:2008/Amd 1:2019

NOW

PROJECT
ISO/FDIS 10993-7
50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Nov 21, 2025

National adoptions

dnaSRPS EN 10993-7:2022  
ISS

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/FDIS 10993-7:2025)

50.20   Proof sent to secretariat or FDIS ballot initiated: 8 weeks

Z076 more

Preview

To view the full content, you need to register or to log in to your account by clicking on the "Log in" button

Login