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EN 1422:1997+A1:2009 Standard



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Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021


Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods


This European standard specifies the minimum performance requirements and test methods of two types of sterilizers employing ethylene oxide gas as the sterilant, either as a pure gas or in admixture with other gases (whether supplied ready mixed or mixed at the point of use) in a temporarily sealed chamber. These sterilizers are intended to be used for medical, dental, pharmaceutical, veterinary and industrial or related purposes. The two types of sterilizers have been designated Type A and Type B respectively using the following criteria: - Type A sterilizers are capable of being programmed by the user; - Type B sterilizers are of limited size and provided with one or more pre-set operating cycles which cannot be varied by the user.


Wednesday 25th of March 2020


This standard is an amendment for "EN 1422:1997"

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