EN 1422 Medical Sterilizers - Testing for Requirements

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN 1422 testing. This standard specifies the requirements and related tests for self-controlled sterilizers that use ethylene oxide (EO) gas as a sterilant, either pure gas or a mixture with other gases, used for sterilization of medical devices and accessories.

This European Standard specifies requirements for ethylene oxide sterilizers operating at super or subatmospheric pressure for:

The performance and design of sterilizers to ensure that the process can sterilize medical devices;
Equipment and controls of these sterilizers required for validation and routine control of sterilization processes.

The test loads described in this European Standard have been chosen to represent a range of loads for evaluating the performance of EO sterilizers for medical devices. However, certain loads may require the use of other test loads.

This European Standard does not specify the tests required to determine the probability of a processed product being sterile, or the routine quality control tests required prior to placing the sterile product on the market. These issues are addressed in prEN ISO 11135:2012.

See the examples in the Bibliography for more information on security. National or regional regulations may exist.

This European Standard does not cover sterilizers that use the injection of EO or mixtures containing EO directly into packages or into a flexible chamber.

EUROLAB assists manufacturers with EN 1422 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.