Објављен
ISO 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.
NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937.
NOTE 2 National or regional regulations can provide requirements for work place safety.
ПОВУЧЕН
ISO 11138-2:2006
ОБЈАВЉЕН
ISO 11138-2:2017
90.93
Одлука о потврђивању стандарда
9. 12. 2022.
Sterilizacija proizvoda za zaštitu zdravlja – Biološki indikatori – Deo 2: Biološki indikatori za postupke sterilizacije etilen-oksidom
60.60 Стандард објављен