Euronda Euronda Helix test including 250 indicator strips

The Euronda Helix test is a steam penetration test according to EN 867-5. It is used for process control of a steam sterilizer with fractionated pre-vacuum (Type B class). To safely sterilize medical devices and instruments with steam, the steam must penetrate them and reach all surfaces and cavities. Packaged sterile goods, tight pockets, and instruments with hollow bodies are not easily penetrated by steam.

What does the Helix test do

The Helix test body simulates a medical device with hard-to-reach cavities. It consists of a long plastic tube, the end of which is connected to an indicator sleeve. The Helix body, along with an indicator strip, is placed in the steam sterilizer and subjected to a sterilization cycle. After the cycle is complete, the test strip indicates whether the steam reached all areas and thus completely sterilized the instrument. Even tiny amounts of residual air lead to improper coloring of the strip.

The Helix test can be used for daily routine checks as well as for batch control. The specific procedure is determined during validation.

Helix Test for Routine Checks

The Helix test is performed with a new test strip every workday before the first sterilization. An existing Helix program in the autoclave can be used for this purpose (refer to the device's manual). Passing the test is a prerequisite for the reliable sterilization of medical instruments.

Helix Test as Batch Control

For batch control, a Helix test with a new indicator strip is added to the instrument load in the autoclave. The correct positioning within the loading pattern is documented during validation. The instruments are sterilized in a validated cycle, and the test strip is subsequently evaluated and documented as part of the release process. Each set of 250 indicator strips is supplied with a test piece. The helix test piece must be replaced after all 250 indicator strips have been used. Tip: Remember to document the execution of the helix test. This ensures legal compliance and can be verified by authorities. Euronda autoclaves can digitally document the helix test. For paper documentation, you will find a printable template in the Documents & Media tab on this page. Used helix strips can be affixed to the template for archiving purposes.