GB 18280.2-2015

GB 18280.2-2015 specifies the methods for establishing the sterilization dose for health care products subjected to radiation sterilization, such as gamma, electron beam, or X-ray irradiation. It is applied by medical device manufacturers and sterilization facilities to validate that a defined radiation dose effectively achieves a sterility assurance level (SAL) of 10⁻⁶, ensuring product safety. This standard is critical for quality control in the production of sterile medical devices, including surgical instruments, implants, and single-use supplies.