EN ISO 1422 Medical Sterilizers, Ethylene Oxide Sterilizers, Requirements and Test Methods

Medical Device Tests

EN ISO 1422 Medical Sterilizers, Ethylene Oxide Sterilizers, Requirements and Test Methods

EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 1422 standard. This European standard specifies requirements and related tests for self-controlled sterilizers used for sterilizing medical devices and accessories, using ethylene oxide (EO) gas as the sterilant, either pure gas or a mixture with other gases.

EN ISO 1422 Medical Sterilizers, Ethylene Oxide Sterilizers, Requirements and Test Methods

This European standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) operating at super- or sub-atmospheric 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.

This European standard does not specify occupational safety requirements for the design and operation of EO sterilization plants.

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

EUROLAB assists manufacturers with EN ISO 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.

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