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.
Текущий статус : WithdrawnДата публикации : 1995-10
Версия : 1
Технический комитет:Biological and clinical evaluation of medical devices