Utrustning för sterilisering

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 11 dec 2018
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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 does not specify requirements for equipment 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 pathogenic substances or human tissues.

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.

This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.

NOTE Attention is drawn to the standards for quality management systems e. g. EN ISO 13485.

Planning and design of sterilizers applying to this European Standard should consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex A.