Norm

NEN-EN 1422:2014 en

Sterilisatoren voor medische doeleinden - Ethyleenoxidesterilisatoren - Eisen en beproevingsmethoden

74,30

Over deze norm

Status Definitief
Aantal pagina's 49
Gepubliceerd op 01-06-2014
Taal Engels
NEN-EN 1422 specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories. This European Standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) working at super or sub-atmospheric pressure for: - the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; - the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes. The test loads described in this European Standard are selected to represent a number of loads for the evaluation of the performance of EO sterilizers for medical devices. However, specific loads may require the use of other test loads.

Details

ICS-code 11.080.10
Nederlandse titel Sterilisatoren voor medische doeleinden - Ethyleenoxidesterilisatoren - Eisen en beproevingsmethoden
Engelse titel Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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