NEN-EN 285:2006+A1:2008 en

Sterilisatie - Stoomsterilisatoren - Grote sterilisatoren

  • Deze norm is ingetrokken sinds 13-05-2009


Over deze norm

Status Ingetrokken
Aantal pagina's 82
Gepubliceerd op 01-03-2008
Taal Engels
This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizer for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads. Large steam sterilizers can also be used during the commercial production of medical devices. This European Standard is not applicable to steam sterilizers designed to process a size of load less than one sterilization module or having a chamber volume less than 60 l. This European Standard does not describe a quality assurance system for the control of all stages of the manufacture of the sterilizer. Planning and design of products applying to this European Standard should consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex A.


ICS-code 11.080.10
Nederlandse titel Sterilisatie - Stoomsterilisatoren - Grote sterilisatoren
Engelse titel Sterilization - Steam sterilizers - Large sterilizers
Vervangen door
Gewijzigd door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen



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