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NA 027

DIN Standards Committee Optics and Precision Mechanics

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

2022-03-22

WI

00206093

Planned document number

FprEN ISO 10993-7

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  

draft standard

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/FDIS 10993-7:2025)
2025-11
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previous edition(s)

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)
2022-01

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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)
2009-11

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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
2008-10

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