NA 027

DIN Standards Committee Optics and Precision Mechanics

Project

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

Abstract

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.

Begin

2022-03-29

WI

00206093

Planned document number

DIN EN ISO 10993-7 rev

Project number

02703364

Responsible national committee

NA 027-07-12 AA - Biological evaluation of medical devices  

Responsible european committee

CEN/TC 206 - Biological and clinical evaluation of medical devices  

Responsible international committee

ISO/TC 194/WG 11 - Allowable limits for leachable substances  

previous edition(s)

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); German version EN ISO 10993-7:2008
2009-02

Order from Beuth Verlag

Contact

Dr.

Susann Minkwitz

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

Tel.: +49 30 2601-2765
Fax: +49 30 2601-42765

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