Norm

NEN-EN 1422:2013 2e Ontw. en

Sterilisatoren voor medische doeleinden - Ethyleenoxidesterilisatoren - Eisen en beproevingsmethoden

  • Deze norm is ingetrokken sinds 02-06-2014

35,70

Over deze norm

Status Ingetrokken
Aantal pagina's 47
Gepubliceerd op 01-01-2013
Taal Engels
This European Standard 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. These sterilizers are primarily used for the sterilization of heat labile medical devices. 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. This standard applies when the sterilizer manufacturer declares compliance with EN 1422 as a means of conformity assessment to the essential requirements of the MDD when intending to supply an EO sterilizer. 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 prEN ISO 11135. This European standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.

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
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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