MEDICAL EQUIPMENT, ETHYLENE OXIDE, STERILIZATION, TESTS, BIOLOGICAL TESTS,BIOASSAY, DETERMINATION, CHEMICAL RESIDUES.
被代替标准
2007-12-21
适用范围
This National Standard of Canada is equivalent to International Standard ISO 10993-7:1995. 1 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
and guidance also is included in informative annexes. EO-sterilized devices that have no patient contact (e.g. in vitro diagnostic
devices) are not covered by this International Standard.