SIST EN 285

SIST EN 285 standard addresses:

sterilisation

steam sterilisers

large sterilisers

This European Standard specifies requirements and the relevant tests for large steam sterilisers primarily used in health care for the sterilisation of medical devices and their accessories contained in one or more sterilisation 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 sterilisers 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 sterilisers designed to accommodate at least one sterilisation module or having a chamber volume of at least 60 l. Large steam sterilisers 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 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.
NOTE 1 Attention is drawn to the standards for quality management systems e.g. EN ISO 13485.
NOTE 2 Environmental aspects are addressed in Annex A.
Source: the Slovenian Standards Institute, taken from the website June 2022.