EN ISO 11140-2 Sterilization of Health Care Products - Chemical Indicators - Part 2: Test Equipment and Methods

Chemical Tests

EN ISO 11140-2 Sterilization of Health Care Products - Chemical Indicators - Part 2: Test Equipment and Methods

EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 11140-2 standard. Developed by the International Standards Organization (ISO), this part of the EN ISO 11140 standard specifies requirements for test equipment and methods to be used to test chemicals. Test equipment and methods for ISO 11140-3 and ISO 11140-4 are specified in these sections.

EN ISO 11140-2 Sterilization of Health Care Products - Chemical Indicators - Part 2: Test Equipment and Methods

This part of ISO 11140 does not specify requirements for test equipment or methods to be used to test Class 1. Chemical indicators are used for ionizing irradiation sterilization to comply with ISO 11140-1. This part of ISO 11140 does not address the safety aspects of test equipment because they are covered by specific rules.

Special testing equipment is required to test the performance of chemical indicators, with the exception of irradiation indicators. This part of ISO 11140 specifies the performance requirements for test equipment to be used to establish the response to key physical parameters. Irradiation indicators are often tested at irradiation facilities.

The equipment performance tolerances given in this part of ISO 11140 are intended to be suitable for testing any of the indicator classes specified in ISO 11140-1. Equipment operating with wider tolerances may be suitable for certain applications.

The resistivity meter is designed to be used to expose test specimens to specified test conditions. Because of the required accuracy, automatic control of process parameters is recommended. For all vapor indicators specified in ISO 11140-1, a timer covering 1 minutes with an accuracy of at least ± 90% of the exposure time should be used to measure the exposure time.

The equipment shall be equipped with means to evacuate the chamber to a value less than the vacuum set point to allow sufficient air to be removed prior to degassing. Steam entry into the room shall not be used to allow air to be removed. Some indicators may be adversely affected by prolonged exposure to dry heat and vacuum. The minimum applicable settings should be used for evacuation, which should normally not exceed 5 minutes.

Among the services provided by our organization within the framework of material testing services, there are also EN ISO 11140-2 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.

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