ISO 10993-7:2008

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

Publication date: Oct 13, 2008

General information

Current stage: 90.60 Effective date: Mar 14, 2022

Originator: ISO

Owner: ISO/TC 194

Type: International Standard

ICS: 11.100.20

Languages: English French

Buying

Status: Published

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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

Revises
ISO 10993-7:1995

NOW

PUBLISHED
ISO 10993-7:2008
90.60 Close of review
Mar 14, 2022

CORRIGENDA / AMENDMENTS

Corrected by
ISO 10993-7:2008/Cor 1:2009

Amended by
ISO 10993-7:2008/Amd 1:2019

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