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dnaSRPS EN 10993-7:2022

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

General information

50.20     Nov 20, 2025

50.60    Jan 16, 2026

ISS

Z076

European Norm

11.100.20  

English  

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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Directive 2017/745

Life cycle

PREVIOUSLY

PUBLISHED
SRPS EN ISO 10993-7:2011

PUBLISHED
SRPS EN ISO 10993-7:2011/A1:2022

PUBLISHED
SRPS EN ISO 10993-7:2011

NOW

PROJECT
dnaSRPS EN 10993-7:2022
50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Nov 20, 2025

Related project

Adopted from FprEN ISO 10993-7 IDENTICAL

Adopted from ISO/FDIS 10993-7 IDENTICAL

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