ISO 10993-7:1995

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

Publication date:   Oct 12, 1995

95.99 Withdrawal of Standard   Oct 13, 2008

General information

95.99 Withdrawal of Standard   Oct 13, 2008

ISO

ISO/TC 194 Biological and clinical evaluation of medical devices

International Standard

11.100.20   Biological evaluation of medical devices

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Scope

Specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices and procedures for the measurement of EO and ECH. Does not apply for EO-sterilized devices that have no patient contact such as in vitro diagnostic devices.

Life cycle

NOW

WITHDRAWN
ISO 10993-7:1995
95.99 Withdrawal of Standard
Oct 13, 2008

REVISED BY

PUBLISHED
ISO 10993-7:2008