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EN ISO 10993-7:2008

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

Publication date:   Aug 21, 2009

General information

60.60 Standard published   Oct 15, 2008

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

11.100.20   Biological evaluation of medical devices

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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 legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
more
93/42/EEC

Medical devices

Harmonized/Supporting
more

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 10993-7:1995

NOW

PUBLISHED
EN ISO 10993-7:2008
60.60 Standard published
Oct 15, 2008

CORRIGENDA / AMENDMENTS

PUBLISHED
EN ISO 10993-7:2008/A1:2022

IN_DEVELOPMENT
EN ISO 10993-7:2008/prA11

PUBLISHED
EN ISO 10993-7:2008/AC:2009

REVISED BY

IN_DEVELOPMENT
prEN ISO 10993-7 rev