Usage

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Control of Ethylene Oxide (EO) sterilization processes.

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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.

Authorization

FDA 510(k)

K191021

 

Characteristics

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.

 

Transport

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.

 

Packing

250 strips per aluminum foil bag.

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