GB/T 18280.2-2025
GB/T 18280.2-2025 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose
Abstract
This document specifies the method of setting the minimum dose required to meet specific sterility requirements and verifying that the sterilization dose of 15 kGy, 17.5 kGy, 20 kGy, 22.5 kGy, 25 kGy, 27.5 kGy, 30 kGy, 32.5 kGy, or 35 kGy can achieve a sterility assurance level (SAL) of 10-6, as well as the method of reviewing the sterilization dose to demonstrate its continuous effectiveness. This document defines the product families used for establishing and reviewing sterilization doses. This document applies to the establishment and maintenance of radiation sterilization doses for medical devices. Note: This document applies to medical devices, but the establishment and maintenance of radiation sterilization doses can also be used for other products.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Pending |
| Standard Code | GB/T 18280.2-2025 |
| CCS | Public medical equipment |
| ICS | Integrated disinfection and sterilization |
| Implement Date | 2027-07-01 |