- February 22, 2018
- Egyptian OSQ
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
Link to Notification