EN
SR EN ISO 11138-2:2017
Sterilizarea produselor de îngrijire a sănătăţii. Indicatori biologici. Partea 2: Indicatori biologici pentru procese de sterilizare cu oxid de etilenă
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.
Status :
In vigoare
Data aprobării : 31.08.2017
Număr de pagini : 19
ICS : 11.080.20 Dezinfectante si antiseptice
Comitet tehnic : 377 - Medicale
- Inlocuieste SR EN ISO 11138-2:2009