Norm

NEN-EN 285:2016 en

Sterilisatie - Stoomsterilisatoren - Grote sterilisatoren

110,00

Over deze norm

Status Definitief
Aantal pagina's 101
Gepubliceerd op 01-01-2016
Taal Engels
NEN-EN-ISO 285 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 sterilizers 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. This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l. Large steam sterilizers can also be used during the commercial production of medical devices. This European Standard does not specify requirements for large steam sterilizers intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues. This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.

Details

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

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