UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

DIN EN 1422

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

active, Most Current
Buy Now
Organization: DIN
Publication Date: 1 August 2014
Status: active
Page Count: 51
ICS Code (Sterilizing equipment): 11.080.10
scope:

This European Standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories.

This European Standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) working at super or sub-atmospheric pressure for:

- the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices;

- the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.

The test loads described in this European Standard are selected to represent a number of loads for the evaluation of the performance of EO sterilizers for medical devices. However, specific loads may require the use of other test loads.

This European Standard does not specify those tests which are necessary to determine the probability of a processed product being sterile, nor the routine quality control tests required prior to release of sterile product. These topics are addressed in prEN ISO 11135:2012.

This European Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.

NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations can exist.

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

NOTE 2 See EN ISO 14937.

This European Standard is not intended as a checklist for suitability of an existing EO sterilizer when assessing compliance with prEN ISO 11135:2012. This standard is not intended to be applied retrospectively.

This European Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products.

NOTE 3 For further information see ISO 10993-7.

Document History

DIN EN 1422
August 1, 2014
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
This European Standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture...
August 1, 2009
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods (includes Amendment A1:2009)
A description is not available for this item.
February 1, 2009
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods; English version EN 1422:1997/prA1:2008
A description is not available for this item.
November 1, 1997
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
A description is not available for this item.

References

Advertisement