HELIOS Automated IFA System | 合法醫療器材資訊網

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HELIOS HTC MODULE - STANDARDIZE YOUR IFA ENVIRONMENT

IFA instructions for use often include recommendations for reagent temperatures and for incubation humidity because the micro-climates in clinical laboratories vary, and sometimes can fall out of range. 

The World Health Organization (WHO) has guidelines for temperature and humidity in the working environment, and the International Standards Organization (ISO) and the US Food and Drug Administration (FDA) both provide humidity and temperature ranges for clinical laboratories.

These regulations describe the optimal range for temperature as 20-25 degrees Celsius. Humidity should be 35-50 percent. IFA standardization is a major concern across laboratories, and many standardization initiatives such as the GEAI, Easy Group, and ICAP have been launched to address this issue. Having consiste...