GB/T 47143-2026 Sterilization of health care products—Low temperature vaporized hydrogen peroxide—Requirements for the development,validation and routine control of a sterilization process for medical devices

Scope

1.1 Applicability
1.1.1 This document specifies the requirements for the development, validation, routine monitoring, and control of the low-temperature sterilization process of medical devices using vaporized hydrogen peroxide (VH2O2) as a sterilization agent.
1.1.2 This document is applicable to process developers, manufacturers of sterilization equipment, manufacturers of sterile medical devices, organizations conducting validation of VH2O2 sterilization processes, and organizations responsible for the sterilization of medical devices.
Note: VH2O2 sterilizers can be used in both medical and industrial institutions. This document acknowledges the similarities and differences between these two applications.

Development Information

Referenced Standards

Adopt standards

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