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.
Status : WithdrawnPublication date : 1995-10
Edition : 1Number of pages : 40
Technical Committee:Biological and clinical evaluation of medical devices