ISO 10993-7:2008

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

Publication date: 13 tet 2008

General information

Current stage: 90.92 Effective date: 16 mar 2022

Originator: ISO

Owner: ISO/TC 194

Type: International Standard

ICS: 11.100.20

Gjuha: anglisht frëngjisht

Buying

Statusi: Publikuar

PDF - 24 988 Lekë

Paper - 24 988 Lekë

CD - 24 988 Lekë

Language

Language in which you want to receive the document.

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

WITHDRAWN
ISO 10993-7:1995

NOW

PUBLISHED
ISO 10993-7:2008
90.92 Standard to be revised
16 mar 2022

CORRIGENDA / AMENDMENTS

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

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

REVISED BY

IN_DEVELOPMENT
ISO/FDIS 10993-7