GB/T 47143-2026

This standard specifies the requirements for developing, validating, and routinely controlling low-temperature vaporized hydrogen peroxide sterilization processes for medical devices. It is applied in healthcare settings and medical device manufacturing facilities to ensure effective sterilization of heat-sensitive instruments, such as endoscopes and electronic components, that cannot withstand high-temperature methods. The standard provides a regulatory framework for process qualification, load monitoring, and cycle parameter verification to maintain sterility assurance levels.