EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 11140-4 standard. This part of the EN ISO 11140 standard developed by the International Organization for Standardization (ISO) specifies the performance of a Class 2 indicator to be used as an alternative to the Bowie and Dick type test for steam sterilizers for wrapped healthcare products (instruments, etc. and porous loads).
A gauge conforming to ISO 11140-4 includes a specific material used as a test load. This test load may or may not be reusable. ISO 11140-4 does not specify requirements for the test load, but does specify the performance of the indicator with the test load it is intended to be used with. The indicator specified in ISO 11140-4:2007 aims to identify poor steam penetration, but does not necessarily indicate the cause of this poor steam penetration.
This part of ISO 11140 does not include test methods for determining the suitability of these indicators for use in sterilizers where the venting step does not include venting below atmospheric pressure.
The Bowie and Dick test is a performance test for steam sterilizers for wrapped products and porous loads. It is therefore performed as a routine performance test during the demonstration of compliance with EN 285 of steam sterilizers and in ISO 17665-1.
Failure of the Bowie and Dick test is symptomatic of a number of potential sterilizer problems that could compromise uniform sterilization of a load to be handled. This malfunction is not conclusive proof that the sterilizer is malfunctioning due to air trapping, air leakage or non-condensable gases, and other causes of malfunction may need to be investigated.
The Bowie and Dick test was designed as a test for successful air evacuation from high-vacuum porous load sterilizers used to sterilize healthcare products. A successful Bowie and Dick test demonstrates rapid and even penetration of steam into the test suite. The presence of air in the package due to an inefficient venting phase, an air leak during this phase, or non-condensable gases in the steam supply are all conditions that could cause the test to fail. The result of the test may also be affected by other factors that inhibit steam penetration. The test does not indicate that the required temperature has been reached or maintained for the time required to achieve sterilization.
A test suite for the Bowie and Dick test consists of two components:
Indicators intended as an alternative to the Bowie and Dick test use different materials for the test load and use gauge systems specifically formulated for use with a defined test load. The term "Bowie and Dick type testing" is used in this section of ISO 11140 because a number of different tests in different countries have historically been called the Bowie and Dick test.
This part of ISO 11140 specifies the performance of the indicator system with the test load it is intended to use. The test load can be offered with an already assembled and single use gauge system, or it can be designed for multiple use with a new gauge system to be placed before each use.
Among the services provided by our organization within the framework of material testing services, there are also EN ISO 11140-4 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
