Strip Integrator EO, 500/bg , 10 bag/Case , Terragene CD16
Usage
Control of Ethylene Oxide (EO) sterilization processes.
Conditions: 600 mg/l EO, RH 60%, 30 °C, 30 minutes // 600 mg/l EO,
RH 60%, 54 °C, 20 minutes.
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
ANMAT (Argentinean National Administration of Drugs, Food and
Medical Devices) PM 1614-4.
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