NEN-EN 1422:2011 Ontw. en

Sterilisatoren voor medische doeleinden - Ethyleenoxidesterilisatoren - Eisen en beproevingsmethoden

  • Deze norm is ingetrokken sinds 09-01-2013


Over deze norm

Status Ingetrokken
Aantal pagina's 48
Gepubliceerd op 01-11-2011
Taal Engels
This European Standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide gas (EO) as the sterilant, either as a pure gas or a mixture with other gases, being used in healthcare facilities, medical device companies or by contract sterilization companies for the sterilization of medical devices and their accessories. These sterilizers are primarily used for the sterilization of heat labile medical devices. This European Standard specifies requirements for ethylene oxide 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. This European standard does not specify those tests which are necessary to determine the probability of a processed product being sterile, nor the routine quality control tests required prior to release of sterile product. These topics are addressed in EN ISO 11135-1. This European standard does not specify requirements for occupational safety associated with the design and operation of ethylene oxide sterilization facilities.


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
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen



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