UNE-EN 285:2016+A1:2023 for
large steam sterilizers is now available. See the requirements and tests applicable to large steam sterilizers primarily used for the
sterilization of medical devices and their accessories contained in one or more sterilization modules.
Standard UNE-EN 285:2016+A1:2023 modifies EN 285:2015, highlighting the update of the standards for consultation in the Regulatory text, in addition to adding Annex ZA in relation to the general safety and operating requirements of Regulation (EU) 2017/745, including new tables.
The standard includes several representative diagrams of the device for various measurements, such as those of non-condensable gases and overheating, among others. It also includes the documentation and information to be supplied with the sterilizer.
The load testing described in this document are selected so that they represent lost of the loads (objects made of metal, rubber and porous materials).
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