BAS EN ISO 11138-2:2018
Sterilizacija proizvoda za zdravstvenu skrb – Biološki indikatori – Dio 2: Biološki indikatori za procese sterilizacije etilenoksidom
Opće informacije
Status: Važeći
Broj strana: 10
Jezik: Engleski
Izdanje: 3.
Metoda usvajanja: Proglašavanje
Nadnevak objave: 29.06.2018
Tehnički komitet:
...
Apstrakt
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.
Životni ciklus
...
Izvorni dokument i stepen usklađenosti
- EN ISO 11138-2:2017, identičan
- ISO 11138-2:2017, identičan