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ETO Chemical Indicator


Control of Ethylene Oxide (EO) sterilization processes.

Applicable Regulation

Designed under Quality Management Systems standards ISO 13485:2016/NS-EN ISO 13485:2016.

ISO 11140-1:2014.

Product Classification

Class 1, according to risk.


FDA 510(k)




Type 4 Chemical Indicator (according to ISO 11140-1). Double punched card strips printed with indicator ink.


Size: 200 x 15 mm.

Initial color: Purple/brown.

Final color: Green.

100 % Toxic Heavy Metals free

Environmental conditions during manufacture

T= 15-30 °C, RH= 30-80 %.

Storage conditions

T= 10-30 °C, RH= 30-80 %, keep out of direct light.



Storage conditions should be strictly followed.

Transport in closed and reinforced boxes in order to avoid damages. The transport of this product does not represent a risk for health.


Shelf life

5 years.



250 strips per aluminum foil bag.

Packing information: product description, instructions for use, classification according to regulation, storage conditions and manufacturer information.

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