Standardization of Color Change Interpretation in Sterilization Chemical Indicators: A Multivariate Study Aligned with International Safety Colors

Objective To address the clinical challenges caused by inconsistent color change criteria among sterilization chemical indicators, this study proposes a standardized interpretation system based on international safety colors (e.g., green for "pass") to enhance the accuracy and global harmonization of sterilization monitoring. Methods A multicenter cross-sectional analysis (2021–2023) evaluated color transitions of 211 chemical indicators across four sterilization methods: steam (n=78), hydrogen peroxide plasma (n=69), ethylene oxide (n=36), and formaldehyde (n=28). Data were analyzed against ISO 11140-1:2014 and GB/T 18282.1-2015 standards using SPSS 26.0 for compliance rate calculations and chi-square tests (α=0.05). Results Significant heterogeneity was observed:Steam sterilization: External labels/tape showed 100% compliance (yellow/green→black), while internal indicators varied (66.67% yellow→black; 100% purple→green). Hydrogen peroxide plasma: External labels/tape exhibited 41.18% compliance (red→yellow); internal indicators achieved 52.17%.Ethylene oxide: 45.00% of external labels transitioned multi-colors to green; internal indicators reached 53.33%.Formaldehyde: External labels demonstrated 33.33% compliance (red/brown→green), while internal indicators achieved 71.43%. Conclusion Manufacturer-specific color standards contribute to an 8.3% clinical misjudgment rate. Adopting universal safety colors (e.g., green for sterilization success) and enforcing regulatory harmonization could reduce errors and improve global healthcare safety. This study provides actionable insights for standardizing sterilization monitoring protocols.