Sterilization validation confirmation and monitoring

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. Strictly carry out installation validation (IQ), operation validation (OQ) and performance validation (PQ) in combination with customer products in accordance with ISO 11135:2014 and GB 18279-2015 Medical Device Ethylene Oxide Sterilization Confirmation and Routine Control Requirements.

3. The sterilization process validation adopts the half-cycle method. Routine release testing uses external PCD and self-contained biological indicators (BI).

4. Daily parameter records are automatically collected and recorded by computer, and the data is kept for no less than 5 years.

Storage conditions of ethylene oxide
Ethylene oxide needs to be stored in a dry, ventilated, light-proof, fire-proof and heat-proof place to prevent it from being heated, damp and exposed to the sun. At the same time, avoid mixing with oxidants, acids, alkalis and flammable substances to avoid danger.