Sterilization of Medical Devices | Egyptian Standard ES 8138/2017

The Ministerial Decree No. 1307/2017 gives the producers and importers a six-month transitional period to abide by the Egyptian Standard ES 8138/2017 which specifies the essential 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 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 Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l. Worth mentioning is that this standard technically adopts EN 285:2015

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