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

Current stage: 30.98 Project deleted Sep 19, 2024

Originator: CEN

Owner: CEN/TC 206 Biological and clinical evaluation of medical devices

Type: 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

Legislation 2017/745

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 10993-7:2008

NOW

ABANDON
EN ISO 10993-7:2008/prA11
30.98 Project deleted
Sep 19, 2024