Technical Services

Technical Services

The ethylene oxide sterilization process is as follows:

1. The company has established a quality management system in accordance with the requirements of ISO 11135:2014, ISO 13485:2016, ISO 9001:2015, en 550 and other international standards.

2. In strict accordance with ISO 11135:2014 and GB 18279-2015, the installation verification (IQ), operation verification (OQ) and performance verification (PQ) of medical device ethylene oxide sterilization confirmation and routine control requirements are carried out.

3. Half cycle method was used to verify the sterilization process. External PCD and self-contained biological indicator (BI) were used for routine release test.

4. The daily parameter records are automatically collected by computer, and the data are stored for no less than 5 years.