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EN ISO 10993-7:2008/prA11

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals EN ISO 10993-7:2008/prA11

General information

10.99 New project approved   Feb 21, 2024

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

Scope

This part of ISO 10993 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 this document is applied, are also included in the informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this part of ISO 10993

Related legislation

Legislation related to this standard

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

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Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 10993-7:2008

NOW

IN_DEVELOPMENT
EN ISO 10993-7:2008/prA11
10.99 New project approved
Feb 21, 2024